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Crospovidone

PVP (polyvinyl pyrrolidone, povidone, polyvidone) is a water-soluble polymer made from the monomer N-vinyl pyrrolidone: more...

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From Pharmaceutical Technology, 10/1/04

AAI Development Services

2320 Scientific Park Dr.

Wilmington, NC 28405

Tel. 800.575.4AAI or 910.254.7000

Fax 910.815.2300

Services@aaidevelopment.com

www.aaidevelopment.com

Description

AAI Development Services, a division of aaiPharma Inc., offers a full spectrum of pharmaceutical product development solutions, including analytical, bioanalytical, pharmaceutics, clinical trials, and regulatory affairs services. AAI finds solutions to pharmaceutical product development challenges every daB helping its clients get to market faster. Since 1979, pharmaceutical, biotechnology, and medical device companies worldwide have benefited from its complete spectrum of resources.

Products and services

Analytical services

* stability

* analytical testing

* microbiology

* physical chemistry

Bioanalytical services

* bioanalytical testing

Pharmaceutical services

* formulation development

* manufacturing (small scale)

Clinical trial services

* data management

* biostatistics

* monitoring and clinical affairs

* clinical trial supplies

Regulatory affairs services

* validation

Circle/eINFO 243

AAPS Career Services

2107 Wilson Blvd., Suite 700

Arlington, VA 22201-3042

Tel. 703.243.2800

Fax 703.243.9532

CareerCenter@aaps.org

www.aapspharmaceutica.com/careercenter

Description

AAPS Career Services began in 2000 by connecting employers looking to fill career opportunities to its growing membership of 12,000. Today, AAPS is the premiere resource to recruiters and employers within the pharmaceutical sciences. Top pharmaceutical and biotechnology companies looking to hire know to find the best-qualified candidates within AAPS membership.

Products and services

AAPS provides an online career center complete with up-to-date job listings, resume submission, job matching, internship opportunities, and professional development resources. AAPS Newsmagazine, the official publication of the American Association of Pharmaceutical Scientists, provides job listings and professional development resources to every subscriber. AAPS Career Centers provide onsite professional development opportunities to attendees during AAPS conferences and in conjunction with the AAPS Annual Meeting and Exposition.

Circle/eINFO 244

Admix, Inc.

234 Abby Rd.

Manchester, NH 03103

Tel. 603.627.2340

Fax 603.627.2019

mixing@admix.com

www.admix.com

Description

Admix provides solutions to your toughest mixing challenges. Admix understands your mixing applications and has the field service experience and ingredient blending expertise to assist you with your formulations. Improve productivity and consistency while lowering formulation costs with Admix's high performance mixing equipment.

Admix's sanitary mixers suit all your mixing, blending, and particle-size reduction needs whether you require in-tank batch mixing, inline mixing and milling, or powder induction. Increase profitability and reduce maintenance costs with our mixing equipment.

Products and services

Admix's sanitary high-speed dispersers; high-shear emulsifiers; in-line emulsifiers and wet mills; sanitary static mixers and blenders; low-speed stainless batch mixers; and vacuum conveying and powder delivery mix stations are designed to meet the newest and toughest hygienic and safety standards for GMP facilities. Many of Admix's products have received the new 3-A third-party verification certification and comply with CGMP stringent standards. Factory acceptance testing, QA, and validation documentation packages are available.

Available in corrosion-free stainless steel configurations, including the motor and drive frame, from 0.5-hp laboratory models through 100-hp production sizes.

Alconox, Inc.

30 Glenn St., Suite 309

White Plains, NY 10603

Tel. 914.948.4040

Fax 914.948.4088

cleaning@alconox.com

www.alconox.com

Description

Alconox, Inc. has been a manufacturer for more than 60 years of a flail line of critical cleaning detergents for the pharmaceutical, medical device, and research laboratory industries. Alconox detergents are available worldwide with consistent formulations, ingredient disclosure, lot number tracking, and validation support.

Products and services

Alconox offers effective acidic, neutral, or alkaline biodegradable detergents that meet typical disposal requirements. The detergents clean capsule fillers, centrifuges, compactors, conveyors, dryers, filters, filling lines, granulators, kettles, mills, mixers, reactors, or any other pharmaceutical or biotechnology production machinery that must be flee of interfering residues. Technical service is provided for cleaning validation procedures.

Circle/eINFO 246

Alexanderwerk, Inc.

427 Sargon Way, Unit E

Horsham, PA 19044

Tel. 215.442.0270

Fax 215.442.0271

alexanderwerk@erols.com

www.alexanderwerkinc.com

Description

The subsidiary of Alexanderwerk AG, a 115-year-old enterprise that prides itself as a global supplier of industrial machinery and plant engineering, Alexanderwerk, Inc. provides the North American market with these same products and services. The company specializes in process equipment and services exclusively for the pharmaceutical, nutraceutical, and chemical industries.

Products and services

Alexanderwerk offers a complete line of processing equipment, which includes our roller compaction, size reduction, extrusion, moist granulation, and grating-shredding machinery. Its Horsham facility offers a machine rental and testing program, spare parts, and technical services. Its two new test stations offer small-scale feasibility studies to larger production runs.

Circle/eINFO 247

Asahi Kasei Chemicals Corp.

1-2, Yurakucho 1-chome, Chiyoda-ku

Tokyo 100-8440, Japan

Tel. +81 33507 2519

Fax +81 3 3507 2375

kaneko.nb@om.asahi-kasei.co.jp

www.asahi-kasei.co.jp

Description

Established in 1931, Asahi Kasei Corporation is a leading chemical company in Japan. Its core chemical operation company, Asahi Kasei Chemicals, is one of the foremost manufacturers of microcrystalline cellulose (MCC) and other excipients in the Asia Pacific region. Asahi Kasei Chemicals has established a good reputation as a manufacturer of high-performance excipients.

Products and services

Asahi's high-performance MCC provides excellent opportunities for the pharmaceutical industry such as:

* CEOLUSR KG-802, a compactible dry binder, facilitates lower compression force suitable for the tableting of pressure-sensitive drugs and film-coated granules

* CELPHERER, MCC spherical starting core, is an optimum core for a wide range of aqueous drug layering and coating systems, and ensures easy manufacturing of coated granules.

Circle/eINFO 248

AssurX, Inc.

305 Vineyard Town Center, Suite 374

Morgan Hill, CA 95037

Tel.408.778.1376

Fax 408.776.1267

info@assurx.com

www.assurx.com

Description

AssurX, Inc. provides companies with enterprise-wide global solutions for their quality management and regulatory compliance needs. CATSWeb is a comprehensive "all-in-one" solution designed to help regulated firms track issues and actions from identification through disposition and corrective action. Companies use the application to manage customer complaints, CAPAs, safety issues, regulatory commitments, supplier quality, audits and findings, plus much more.

Products and services

AssurX, Inc. provides CATSWeb, the only true zero-client, 100% Web-based enterprise quality management system that is fully 21 CFR Part 11 compliant and used by major FDA-regulated companies worldwide. CATSWeb lets you combine all of your quality processes into a single, reliable, enterprise-wide solution. AssurX also offers business process consulting, implementation, training, and validation services.

Circle/eINFO 249

BASF

3000 Continental Dr. North

Mount Olive, NJ 07828-1234

Tel. 800.443.0627

Fax 973.426.5535

pharmasolutions@basf.com

www.basf.com/pharma

Description

BASF Pharma Solutions offers the pharmaceutical industry a wide range of products and services, including high-quality active ingredients, multifunctional excipients, pharmaceutical finishing, and contract manufacturing-all supported by the experience and expertise of its technical service center staff. All BASF Pharma Solutions products are manufactured to CGMP standards; BASF also works closely with FDA, DEA, and other regulatory agencies to provide products that are fully compliant in every respect.

Products and services

BASF Pharma Solutions offers actives such as ibuprofen, pseudoephedrine, ephedrine, caffeine, and theophylline; highly functional excipients such as povidone, crospovidone, and copolyvidone, which are sold under the trade names Kollidon[R] and Ludipress[R]; Kollicoat[R] coatings; PVP-iodine; retinoids; soinbilizers and surfactants including Cremophor[R], Lutrol[R], Solutol[R] HS 15, and Soluphor[R] P.

BASF Pharma Solutions offers pharmaceutical finishing at its Shreveport, Louisiana facility. This facility offers full-service tablet manufacturing and packaging as well as liquids and creams manufacturing.

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Baxter Healthcare Corp.

Route 120 and Wilson Roads

Round Lake, IL 60073

Tel. 800.353.0887

Fax 812.332.3079

busdev@baxter.com

www.baxterdrugdelivery.com

Description

Baxter Healthcare Corporation's BioPharma Solutions business offers contract services and technologies for parenteral drugs. The company has partnered with more than 250 clients, including the top pharmaceutical and biotech companies. For Small Biotech to Big Pharma, Baxter offers development and manufacturing expertise with a portfolio of best-in-class services and proprietary technologies, from development through commercialization. Baxter's two proprietary formulation technologies are NANOEDGE dispersion technology for solubility challenges and PROMAXX protein microsphere technology for immediate or sustained release and for various administration routes. Baxter's technologies and services also include biopharmaceutical active ingredient development and manufacturing, enhanced packaging, and contract services such as form-fill-finish of drug product into syringes, vials, and cartridges as well as cytotoxic chemical synthesis (API) to scale-up for commercial production. Baxter's Bloomington, Indiana, facility has increased capacity for syringe and vial filling-finishing, lyophilization, and added new capability for cartridge filling-finishing and automated kitting.

Circle/eINFO 251

BD Pharmaceutical Systems

1 Becton Dr.

Franklin Lakes, NJ 07417

Tel. 201.847.4017 or 800.225.3310

Fax 201.847.4847

BDPS_Marketing@bd.com

www.bdpharma.com

Description

BD Medical Pharmaceutical Systems is the industry leader in providing quality, prefillable parenteral drug delivery systems for the pharmaceutical industry. Whether it is a prefillable syringe, nasal drug delivery system, intravenous infusion system, diluent syringe, dry-drug reconstitution system, a safety needle, or the latest in self-injection technology, BD delivers.

Products and services

Prefills can be added at any point during a product's life cycle to make it more desirable. BD provides cost-effective alternatives to conventional drug delivery, innovative designs that meet healthcare professionals' demands, and patientfriendly products to fulfill home healthcare needs. With more than 100 years of experience, BD provides the expertise and experience you need in your drug delivery partner. BD customizes its delivery systems to the unique requirements of each product, and provides the support and resources to help you achieve your goals.

Circle/eINFO 252

Ben Venue Laboratories

PO Box 46568

Bedford, OH 44146

Tel. 440.232.3320

Fax 440.439.6398

phansbury@cle.boehringer-ingelheim.com

www.benvenue.com

Description

Ben Venue Laboratories provides contract manufacturing and development of sterile products, from clinical to commercial. Since 1938, Ben Venue has provided contract manufacturing and developed liquid and lyophilized parenteral products. More than 800 products have been successfully produced.

Products and services

* 8 aseptic fill lines

* 21 production lyophilizers, totaling more than 5400 [ft.sup.2] of shelf space

* vacuum drying from nonaqueous solvents

* terminal sterilization of liquids

* product-specific process validation

* product and process development of sterile products

* formulation development

* cycle development for lyophilization

* performance of stability studies

* analytical methods development

* chemical and microbiological control laboratories

* methods validation

* audited by FDA, EMEA, and MCA.

Circle/eINFO 253

Boston Analytical, Inc.

8 Industrial Way, Unit D3

Salem, NH 03079

Tel. 603.893.3758

Fax 603.893.1268

info@bostonanalytical.com

www.bostonanalytical.com

Description

High-quality, fast, accurate testing. Since 1987, Boston Analytical has provided superior contract analytical testing services to pharmaceutical manufactures worldwide. Personal contact, friendly, effective communications, quality service, competitive pricing, and rapid turnaround are the cornerstones of Boston's business. All work is performed in Boston's greatly expanded CGMP-compliant laboratory located near Boston.

Products and services

Specialties include method development and validation of stability indicating analytical procedures, stability testing and storage under ICH guidelines, automated dissolution testing, product release testing, HPLC-GC, AA, FT-IR, fluorescence, polarimetry, and UV-spectrometry. Boston Analytical currently is building a new state-of-the-art microbiology laboratory that will feature microbial identification performed using the applied Biosystems MicroSeq Genetic Analyzer[R].

Circle/eINFO 254

Brevetti C.E.A.

Victor International Marketing, Inc.

Morristown, NJ 07960

Tel. 973.267.8900

Fax 973.267.0098

www.BrevettiUSA.com

www.Victorlnternational.com

Description

Brevetti, located in Sovizzo, Italy, has been manufacturing vision inspection equipment since 1957. Brevetti inspection systems provide maximum flexibility in software configuration, operational parameters, vision tool adjustment, and programming. Brevetti continues to invent new machines and inspection parameters to meet tomorrow's demand for higher quality products. Brevetti has more than 600 machines installed and validated worldwide.

Products and services

* vision inspection machines for particle and cosmetic inspection of liquid and freeze-dried products in parenteral containers, including leak detection equipment

* state-of-the-art software with algorithms capable of discerning between bubbles and actual extraneous matter

* on-screen "live" image of inspected containers (graphic and color display of defects)

* one camera per board guarantees image acquisition and processing that's real time, all the time.

Circle/eINFO 255

Buender Glas GMBH

Erich-Martens-Strasse 26-32

D-32257 Buende

Tel. +49 5223 164 0

Fax +49 5223 164 211

buenderglas@gerresheimer.com

www.buenderglas.com

Description

Gerresheimer pharmaSystems (i.e., Buender Glas Gmbh and Polfa SA), is an internationally operating manufacturer of pharmaceutical systems and packaging solutions.

Products and services

Gerresheimer pharmaSystems offers pharmaceutical packaging concepts, like prefillable syringes, where nurses, medical doctors, and patients profit from optimum application and dosage reliability in line with their precise needs.

Circle/eINFO 256

Cardinal Health

14 Schoolhouse Rd.

Somerset, NJ 08873

Tel. 732.537.6200

Toll-free 866.720.3148

Fax 732.537.5945

PTS@cardinal.com

www.cardinal.com/pts

Description

Cardinal Health is a leading provider in product development, drug delivery technologies, contract manufacturing, packaging, and healthcare marketing services, serving the global pharmaceutical and biotechnology industry. With proven expertise and innovation, Cardinal Health brings its customers innovative expertise throughout a drug's development, launch, and entire life cycle.

Products and services

Cardinal offers a full range of drug development services, such as discovery support, synthesis, pharmaceutics, analytical chemistry, microbiology, structural chemistry, clinical manufacturing, and clinical supply services as well as product development for both small and large molecules. The company also has expertise in inhalation and radiopharmaceutical product development, and can offer innovative cell-line development using its proprietary GPEx[TM] technology.

Cardinal also provides manufacturing for nearly every dose form on the market today. Along with its proprietary dose forms, the company also manufactures traditional oral dose forms (tablets, capsules, liquids), sterile dose forms (lyophilization, fill/finish manufacture in vials, ampoules, preffilled syringes, and blow-fill-seal aseptic technology), and topical and inhaled forms. Cardinal also produces biologics for preclinical and clinical studies, and both clinical and commercial radiopharmaceuticals and can also help improve yields in commercial biologics production using its proprietary GPEx[TM] technology.

Circle/eINFO 257

Central Research Laboratories

250 Highway 19

Red Wing, MN 55066

Tel. 651.388.3565

Fax 651.388.1232

sales@centres.com

www.centres.com

Description

Central Research Laboratories (CRL) is a worldwide leader in remote material handling solutions, including telemanipulators, gloveports, and double-door transfer systems for contained environments. CRL products are used by pharmaceutical manufacturers using isolator technology that offers solutions to the twin challenges of maintaining sterility and containing potent compounds.

Products and services

CRL has recently developed a special patented technology known as "dry-heat" technology for use with its sterilizing transfer ports. Industry experts recognize it as the most reliable and effective sterilization technology available today for material transfers in aseptic barrier systems or isolators. Testing has shown CRL's sterilizable ports achieve a six-log spore reduction. This technology is part of an FDA-approved process and is used by the top North American pharmaceutical manufacturers.

Circle/eINFO 258

Charles Ross & Son Co.

710 Old Willets Path, PO Box 12308

Hauppauge, NY 11788

Tel. 800.243.ROSS

Fax 631.234.0691

sales@mixers.com

www.mixers.com

Description

Ross has more than 150 years of growth and leadership in specialty mixing worldwide. Ross mixers and blenders are built on five continents and sold in most industrialized nations, for use in nearly all process industries. In the United States alone, Ross products are engineered and built in five plants totaling nearly 200,000 [ft.sup.2] dedicated to engineering, R&D, manufacturing, and process testing.

Products and services

Ross offers a broad line of sanitary rotor-stator mixers, ultra-high shear inline mixers, multiagitator mixers and granulators, vacuum mixers and homogenizers, and sanitary blenders. Turn-key systems are available with advanced multiagitator mixing systems, combined with side phase preparation vessels, powder induction capability, Vacuum and temperature control, CIP and SIP, all controlled by advanced PLC-based control systems.

Circle/eINFO 259

Chemir Pharma Services

10320 USA Today Way

Miramar, FL 33025

Tel. 866.286.2333

Fax 954.432.9015

www.chemirpharma.com

Description

Chemir Pharma Services provides con tract drug development services for the following pharmaceutical entities in a CGMP and FDA registered facility:

* drug substances and excipients

* oral dosage forms

* topicals

* transdermals

* liquids and semisolids

* inhalation dosage forms.

Products and services

* synthetic chemistry: reference standards and intermediates, mg to kg

* characterization services: isolation, purification, structure elucidation, and establishment of purity

* preformulation evaluations: compatibility studies, prototype evaluations, physical-chemical properties determination

* formulations development: supporting Phase I clinical studies

* methods development and validation: potency, dissolution, impurities, cleaning per ICH guidelines

* quality, control: global release of APIs, excipients, finished products

* stability: storage and testing for APIs, finished products

* clinical supplies: expedited via Phase I Express.

Circle/eINFO 260

Coating Place Inc.

200 Paoli St., PO Box 930310

Verona, WI 53593

Tel. 608.845.9521

Fax 608.845.9526

coatings@encap.com

www.encap.com

Description

The Coating Place Inc. is a privately owned contract manufacturer specializing in Wurster fluid bed coating services for the microencapsulation of a variety of solid particles. Dr. Dale Wurster patented this coating process in the 1950s. Researchers from his group founded Coating Place in 1976. With more than 30 years of Wurster coating experience, Coating Place can take on your toughest projects.

Products and services

The company's recently expanded 110,O00-[ft.sup.2] CGMP facility services include formulation development, technology transfer, scale-up, and commercial manufacturing with laboratory support. Applications include controlled and sustained release, enteric, and taste-masked and moisture barrier coatings. Facilities process solvent and aqueous formulations. Coating Place call accommodate batch sizes ranges from 0.01 to more than 600 kg.

Circle/eINFO 261

Cole-Parmer Instrument Co.

625 East Bunker Court

Vernon Hills, IL 60061

Tel. 847.549.7600 Toll Free 800.323.4340

Fax 847.247.2929

info@coleparmer.com

www.coleparmer.com

Description

Cole-Parmer has grown to be one of the leading worldwide sources for fluid handling, laboratory equipment, and industrial instrumentation needs. Cole-Parmer combines technical expertise with a broad selection of products backed by a dedicated staff of customer service representatives and highly trained application specialists.

Products and services

The New 2005/06 Cole-Parmer[R] General Catalog features more than 60,000 products--including 10,000 new products and 20 new product sections. Inside, find 2500 pages filled with hard-to-find items as well as everyday basics, including brand names. Innovative products for applications in fluid handling, industrial technology, research, biotechnology, chemical processing, pharmaceuticals, and more.

Circle/eINFO 262

Covance Laboratories Inc.

3301 Kinsman Blvd.

Madison, WI 53704

Tel. 888.COVANCE

Fax 608.241.7227

info@covance.com

www.covance.com

Description

For more than 50 years, Covance has been an industry leader in providing quality data and scientific expertise to the pharmaceutical and biotechnology industries. Covance has an unparalleled combination of global scope and breadth of expertise, as well as scientists who are committed to providing solutions for our customers' development needs.

Products end services

Covance offers complete analytical and stability testing services that include method feasibility, development and validation; stability and release testing; and specialty services for inhaled products, nitrosamines, closure and container analysis, and extractables and leachables.

Circle/eINFO 263

Croda Inc.

300-A Columbus Circle

Edison, NJ 08837

Tel. 732.417.0800

Fax 732.417.0804

marketing-pharmaceutical@crodausa.com

www.crodausa.com

Description

Croda is a manufacturer of lipid-based excipients for parenteral, topical, and oral dosage form design. At this year's meeting, we will be offering information about a new product, Super Refined PEG 400 NF, that is virtually free of polar impurities. New clinical data also will be available for our ultra-purity, medical-grade lanolin products.

Circle/eINFO 264

DataTrace Division of Mesa Laboratories, Inc.

12100 W. 6th Ave.

Lakewood, CO 80228

Tel. 303.987.8000

Fax 303.987.8989

datatracesales@mesalabs.com

www.mesalabs.com

Description

The DataTrace Division of Mesa Laboratories, Inc. develops, manufactures, and markets high-quality, computer-based electronic measurement instruments for use in industrial, pharmaceutical, and food applications in the United States and worldwide.

Products and services

The Micropack III Tracer is a wireless temperature-monitoring system. The MPIII delivers precise measurements ([+ or -] 0.1[degrees]C) throughout a wide temperature range from -20 to + 140[degrees]C. This precision, combined with its very small size, allows the MPIII to provide extremely accurate profiles without disrupting manufacturing, storing, shipping, testing, and other processes. The Tracers are NIST traceable, and the system complies with FDA 21 CFR Part 11. Field calibration, field replaceable battery, and the Tracer's battery-life indicator help save the customer time and money.

Circle/eINFO 265

Degussa Corporation

2 Turner Pl.

Piscataway, NJ 08855

Tel. 877.ROHMUSA ext. 5383 or 732.981.5383

Fax 732.981.5484

Andrew.Honeycheck@degussa.com

www.rohmamerica.com

Description

Degussa Pharma Polymers offers a complete range of EUDRAGIT, acrylic polymers, and technologies for controlled release oral solid dosage forms, including targeted enteric delivery systems via pH-dependent acrylic polymers and sustained-release coating systems with pH-independent acrylic polymers. The complete range of EUDRAGIT, acrylic polymers are available as aqueous dispersions or solid polymers depending on your specific product requirements.

Products and services

* gastroresistent coating with EUDRAGIT[R] L 30 D-55 and EUDRAGIT[R] L 100-55

* controlled-release formulation technology with EUDRAGIT[R] RS 30-D, EUDRAGIT[R] RL 30-D, and EUDRAGIT[R] NE 30-D

* transdermal therapy systems with EUDRAGIT[R] E-100

* protective, insulation, and taste-masking coatings with EUDRAGIT[R] E-100, EUDRAGIT[R] EPO, and EUDRAGIT[R] RL 30-D

* EUDRACOL[TM] colon-targeted, sustained-release drug delivery technology.

Circle/eINFO 266

DMV International

PO Box 13

NL-5460 BA Veghel

The Netherlands

Tel. +31 413 372222

Fax +31 413 372360

pharma@dmv-international.com

www.dmv-international.com

Description

DMV International develops, produces, and markets excipients for the pharmaceutical industry worldwide. DMV's commitment is to supply top-quality products that comply with the latest CGMP standards and to specialize in technical sales support that ensures DMV's customers receive the full advantage of the latest excipient technologies.

Products and services

DMV offers a range of pharmaceuticalgrade lactose products. The brand Pharmatose[R] includes a range of milled, sieved, and direct-compressible (DCL) products, whereas Respitose[R] represents a range of inhalation lactose products. DMV also offers superdisintegrants, Primellose[R] and Primojel[R].

Circle/eINFO 267

Domino Specialty Ingredients

1100 Key Highway East

Baltimore, MD 21230-5180

Tel. 800.446.9763

Fax 410.783.9710

dominospecialtyingredients@

dominofoods.com

www.dominospecialtyingredients.com

Description

Domino--a name known by consumers for filling the nation's sugar bowls--is known among drug manufacturers as a leading source of innovative, sophisticated sugar products that solve problems, reduce production costs, and help to improve end-product performance. The story of Domino Specialty Ingredients shows how a pure and simple ingredient like sugar can he transformed into a whole array of unique excipient technologies for the pharmaceutical industry and can help drug manufacturers develop new and appealing products in a variety of markets.

Products and services

Domino Specialty Ingredients offers ingredient materials appropriate for branded ethical pharmaceuticals, generic drugs, over-the-counter pharmaceuticals, vitamins and supplements, including Di-Pac[R] direct compacting and tableting sugar, and a full line of NF Sugars.

Circle/eINFO 268

The Dow Chemical Company

Midland, MI 48674

Tel. 800.477.4369

Fax 989.832.1465

www.dow.com

Description

Dow is a leading science and technology company that provides innovative chemical, plastic, and agricultural products to many essential consumer markets. With annual sales of $33 billion, Dow serves customers in 180 countries in a wide range of markets.

Products and services

* excipients include Methocel[TM] and Ethocel[TM] cellulose ethers, Polyox[TM] water-soluble resins NF, and Dow polyethylene glycols

* process development and contract manufacturing of biologicals, APIs/ drug substances, and intermediates through Dow's pharmaceutical services

* contract development and manufacturing of complex therapeutic proteins through Dow plant-based biopharmaceuticals

* technologies in biotargeted radiopharmaceuticals and enhanced drug solubility

* Angus Chemical Company nitroparaffin derivatives

* Versene[TM] and other specialty chelating agents

* functional emulsifiers, humectants, and viscosifiers.

Circle/eINFO 269

DPT Laboratories, Ltd.

318 McCullough

San Antonio, TX 78215

Tel. 866.CALL.DPT (225-5378)

Fax 210.829.8733

confidence@dptlabs.com

www.dptlabs.com

Description

DPT specializes in the full-service development, manufacturing, packaging, and worldwide distribution of semisolid and liquid, prescription, OTC, and biotech products. From preformulation through validation and stability, DPT affords you full-service commercial production of creams, lotions, ointments, gels, aerosol foams, oral suspensions and solutions, and nasal sprays through its advanced development services offerings.

Products and services

DPT provides confidence in turnkey and stand-alone outsourcing solutions: Advanced development solutions

* technical expertise in semisolids and oral liquids

* formulation development and analytical chemistry expertise

* distinctive platform technologies available for licensing.

Specialized production solutions

* manufacturing of semisolids and liquids

* ability to manage hard-to-handle ingredients

* explosion-resistant manufacturing

* state-of-the-art compartmentalized manufacturing services.

Innovative packaging solutions

* thermo- and cold-form blister packaging

* tube, cup, bottle, and jar filling

* pouch packaging

* specialty dosage delivery forms.

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DSM Pharmaceuticals Inc.

5900 NW Greenville Blvd.

Greenville, NC 27834

Tel. 252.707.2307

Fax 252.707.7046

info.dsmpharmaceuticals@dsm.com

www.dsmpharmaceuticals.com

Description

DSM Pharmaceuticals, Inc., a leading provider of contract manufacturing services to the pharmaceutical and biotechnology industries, is located in Greenville, North Carolina. Capabilities include manufacturing of sterile liquids and lyophilized products to solid, semisolid, and liquid forms. Using proprietary technologies such as LyoAdvantage[TM] and LiquidAdvantage[TM], DSM Pharmaceuticals can deliver unparalleled quality assurance in sterile manufacturing.

Products and services

DSM Pharmaceuticals offers performance unparalleled in the industry by providing leading systems for manufacturing, quality, regulatory compliance, and project management. DSM Pharmaceuticals ensures a seamless transfer of operations through most phases of production. DSM Pharmaceuticals is approved by both FDA and EMEA thereby allowing your products to be launched globally from one manufacturing site.

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EaglePicher Pharmaceutical Services, LLC

13605 W. 96th Terrace

Lenexa, KS 66215

Tel. 913.541.0525

Fax 913.888.3582

inquiry.pharmaceuticalservices@

eaglepicher.com

www.eaglepicher.com

Description

EaglePicher Pharmaceutical Services specializes in the custom CGMP synthesis of preclinical, investigational, and commercial APIs, radiolabeled compounds, and cytotoxic and high-potency pharmaceuticals at FDA-inspected, US-based facilities.

Products and services

EaglePicher's complete line of services includes custom radiolabeling (carbon-14, tritium, and stable isotopes), CGMP active ingredient and intermediates synthesis, reference standards and metabolite synthesis, process development and validation, analytical services, process scale-up, CGMP radiolabeling, clinical API supply, commercial API supply, and regulatory expertise. With state-of-the-art facilities and unsurpassed expertise, EaglePicher Pharmaceutical Services can support every stage of any drug development project.

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Eastman Chemical Company

PO Box 431

Kingsport, TN 37662-5280

Tel. 800.EASTMAN, ext. 2987

excipients@eastman.com

www.eastman.com

Description

Eastman Chemical Company is a global company that produces more than 1200 chemicals, fibers, and plastics. With corporate headquarters in Kingsport, Tennessee, Eastman has approximately 15,800 employees with annual sales of $5.4 billion.

Products and services

Eastman Chemical Company features an extensive line of products for controlled drug delivery and pharmaceutical processing, including vitamin E TPGS NF for bioenhancement, enteric polymers, acrylic emulsions, and cellulose esters. The products are used in pharmaceutical, veterinary, and other controlled-release applications. Eastman also offers custom manufacturing of pharmaceutical intermediates and raw materials.

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Eisai Machinery U.S.A. Inc.

3 University Plaza

Hackensack, NJ 07601

Tel. 201.287.2111

Fax 201.692.1972

emu@eisai.com

www.eisaiusa.com

Description

Eisai distributes pharmaceutical production systems and equipment that are highly regarded by pharmaceutical manufacturers all over the world for their superb quality, safety, efficiency, and accuracy.

Guided by a corporate philosophy that defines our role as a human healthcare company, Eisai continues to improve and expand our range of pharmaceutical and medical products. Research into industry requirements has yielded Eisai's most advanced line of particulate, cosmetic de fect, lyophilized inspection equipment, and syringe inspection machines.

Products and services

Eisai provides automated inspection machines for the detection of particulate matter and cosmetic defects in parenteral solutions. Eisai proudly announces a new P-LIM (prelyophilized inspection machine), in addition to its latest state-of-the-art vision systems for all lyophilized vial products. Other machines include syringe inspection machines; leak detection machines for ampoules and vials; capsule and tablet weight inspection machines; and semi automatic machines for both liquid and tablets. Complete validation and technical service packages are available by highly trained staff.

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Emerson Process Management

12301 Research Blvd.

Austin, TX 78759

Tel. 800.PlantWeb

Fax 512.832.3443

info@easydeltav.com

www.EasyDeltaV.com

Description

Emerson Process Management is a leading global supplier of products, services, and solutions that measure, analyze, control, automate, and improve process and batch-related operations. Emerson's company evolved from the business previously knows as Fisher-Rosemount, which was already a recognized leader in automation products and technology.

Products and services

Emerson Process Management offers broad capabilities to help customers control, connect, validate, and manage their business. Specifically, Emerson has augmented its best-in-class measurement, analytical, and control products, and innovative PlantWeb[R] architecture with a broad array of engineering, consulting, maintenance, and project management services.

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ErtelAlsop

PO Box 3358

Kingston, NY 12402-3358

Tel. 800.553.7835 or 845.331.4552

Fax 845.339.1063

sales@ertelalsop.com

www.ertelalsop.com

Description

ErtelAlsop is a leading US manufacturer of liquid depth filter media and machinery for pharmaceutical and biotech applications. With a unique product line, three manufacturing facilities, and an international network of sales representatives and distributors, ErtelAlsop is well positioned to serve the global market.

Products and services

ErtelAlsop has been an innovative manufacturer of superior quality filter media, lenticular filter cartridges, and housings, plate and frame filter presses, and laboratory filter equipment for more than 83 years. ErtelAlsop is proud to be an exclusive manufacturer of media impregnated with Celpure[R] high-purity diatomaceous earth and an exclusive supplier of P-grade filter paper. From laboratory scale-up to full-size production, ErtelAlsop provides the product your application demands.

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Eurand Inc.

845 Center Dr.

Vandalia, OH 45377

Tel. 937.898.9669

Fax 937.264.2656

www.eurand.com

Description

Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug delivery technologies. As an industry leader, Eurand has constructed state-of-the-art manufacturing facilities capable of delivering innovative expertise in the following areas:

* fluid bed technology (solvent and aqueous capabilities)

* tableting and capsule filling

* taste-masking (leading industry expert)

* granulating and drying

* process development

* controlled-release drug delivery

* analytical methods development and validation

* stability testing and storage

* pilot- to commercial-scale capabilities

* DEA licensed for scheduled substances.

With more than 30 years of industry experience, Eurand is the choice when quality, service, and expertise matter.

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Exygen Research

3058 Research Dr.

State College, PA 16801

Tel. 800.281.3219

Fax 814.272.1019

info@exygen.com

www.exygen.com

Description

Exygen Research is a CRO providing CGMP- and GLP-compliant analytical support to the pharmaceutical industry. Since its inception in 1986, Exygen has maintained a reputation for delivering high-quality, innovative, and cost-effective analytical solutions. Exygen provides a heroic level of service to the clients who place their trust in its laboratory.

Products and services

Exygen offers a full range of analytical services including:

* analytical method development, validation, and transfer

* bioanalytical chemistry

* chromatographic analysis

* characterization of analytical reference standards

* dissolution testing

* elemental analysis

* identification of impurities and degradation products

* metabolite isolation, identification, and structural elucidation

* radiochemical determinations

* stability and release testing

* stability storage

* thermal analysis.

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Fette America, Inc.

400 Forge Way

Rockaway, NJ 07866

Tel. 973.586.8722

Fax 973.586.0450

sales@fetteamerica.com

www.fetteamerica.com

Description

Recognized worldwide for its precision tablet press machinery, Fette is an industry leader in innovation and design. With unmatched service and support, Fette offers complete services, including new and used machine sales, technical assistance, machine installations, training classes and seminars, validation, maintenance, troubleshooting, repairs, spare parts, and tooling.

Products and services

The Fette Contained Wash-in-Place (WiP) Tabletting System includes Fette's proven WiP tablet press, a fully integrated alpha-beta charge valve, and isolator units to house the deduster, metal check, and IPC unit. With operator exposure levels, registered in nanograms, the system can safely process even the most toxic of products. Overall benefits include enhanced employee safety, faster changeover times, and savings in labor, space, and operator costs.

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The Fitzpatrick Company

832 Industrial Dr.

Elmhurst, IL 60126

Tel.630.530.3333

Fax 630.530.0832

info@fitzmill.com

www.fitzmill.com

Description

The Fitzpatrick Company has main rained a reputation as a global leader in process technology for six decades. Every machine Fitzpatrick sells is customized to specific requirements. Fitzpatrick is a solutions provider, helping companies do business more efficiently and profitably. Once purchased, Fitzpatrick machines are backed by a responsive team of support technicians.

Products and services

The FitzMill comminutor is ideal for your size reduction needs. This equipment can be configured for delumping, comminution to a specific particle range, or fine-grinding applications. Equipment is available to meet your capacity and configuration needs.

The Chilsonator dry-granulation system granulates pharmaceutical powders, providing precise control of particle size and density without adding liquids or binders.

The FitzSieve is designed for gentle size reduction and delumping. Applications include sizing and delumping material that has been granulated in a high-shear granulator or dried in a fluid bed or tray dryer.

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Flexicon America, Inc.

156 College St.

Burlington, VT 05401

Tel. 802.657.3232

Fax 802.657.3202

flexicon@flexiconamerica.com

www.flexiconamerica.com

Description

Flexicon America, Inc. offers Flexicon precision-engineered peristaltic liquid filling and capping systems for injection liquids, infusion liquids, cough medicine, floating vitamins, eye drops, blood products, antiseptics, serums, lyophilization, diagnostic kits, biotechnologicals, herbal medicines, and other products. Flexicon, a world leader in peristaltic filling, features sterility, fast changeover, quick validation, reliability, and the ability to handle live cells.

Products and services

Flexicon liquid filling technology simplifies pharmaceutical and biotechnology cleaning validation with a new state-of-the-art peristaltic pump technology that results in significant cost savings.

One hundred percent security against product cross contamination is attained by disposing of the entire fluid path. For each production batch, a new sterile disposable tubing fluid path is used. In most cases product changeovers can be accomplished in less than 5 minutes.

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Fulcrum Pharma Developments, Inc.

2803 Slater Rd., Suite 125

Morrisville, NC 27560

Tel. 919.226.1440

Fax 919.226.1441

www.fulcrumpharma.com

Description

Fulcrum Pharma Developments is a complete drug development and management company with a highly experienced team of scientists from relevant disciplines and multiple therapeutic areas in the pharmaceutical and biotech industry. Fulcrum customizes and manages confidential drug development programs to complement your capabilities and accelerate your drug candidates towards commercial success.

Products and services

Fulcrum delivers tailor-made drug development services to meet and exceed your goals. Fulcrum's in-house drug development expertise and network of qualified suppliers provide a uniquely personalized drug development service for pharmaceutical and biotech companies. Fulcrum can design, implement, and manage the entire drug development process or provide specialists to complement your internal resources for maximum productivity without duplication of effort.

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Galbraith Laboratories, Inc.

2323 Sycamore Dr.

Knoxville, TN 37921-1700

Tel. 865.546.1335 or 877.449.8797 (toll free)

Fax 865.546.7209

labinfo@galbraith.com

www.galbraith.com

Description

Galbraith Laboratories, Inc., was founded in 1950 by Dr. Harry W. Galbraith as an independent microanalytical laboratory. Today, Galbraith is recognized as one of the largest and most experienced microanalytical laboratories in the world. With a staff of 75 employees, our laboratory performs more than 250,000 analyses per year for 7000 clients worldwide. Galbraith's client base is a blend of businesses, universities, and government agencies, including most of the top Fortune 500 companies.

Products and services

Galbraith provides a full range of analytical services, from fast turnaround-high volume routines to complex and specialized analyses, including tests for all elements, trace and microchemical analyses, organic and inorganic analyses, assays and monographs, physical property testing, regulatory compliance, method development, method validation, customized support services, and pharmaceutical, environmental, and industrial testing.

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GE Fanuc Automation

325 Foxborough Blvd.

Foxborough, MA 02035

Tel. 508.698.3322

Fax 508.698.6973

salessupport@gefanuc.com

www.gefanuc.com

Description

GE Fanuc is dedicated to bringing a wide range of solutions to the life science industry. GE leverages its software and hardware technologies with expertise in addressing the unique requirements of the industry, including compliance, documentation, and validation. By addressing these important issues, GE helps manufacturers grow their business by reducing costs, mitigating risks, and bringing increased visibility from the factory floor to the business system.

Products and services

GE Fanuc delivers manufacturing excellence and GMP-compliant solutions to customers in the pharmaceutical, biotechnology, medical devices, and medical equipment industries, including:

* solutions for GMP Compliance (including our "Designed for 21 CFR Part 11'" applications)

* change management solutions

* plant performance analysis and execution software

* plant floor data collection and analysis

* batch execution and operator workflow

* visualization and control, trending and alarming

* innovative automation technology.

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GELITA USA Inc.

2445 Port Neal Industrial Rd.

Sergeant Bluff, IA 51054

Tel.712.943.5516

Fax 712.943.3372

service.na@gelita.com

www.gelita.com

Description

The Gelita Group, a world market leader in the gelatin market, supplies a full range of pharmaceutical gelatin types. The multifunctional technological properties of Gelita pharmaceutical gelatin are appreciated especially in the production of hard and soft capsules and as a matrix component for vitamin powders. Special Gelita collagen-hydrolysates are used in health and nutrition products to promote joint health.

Products and services

The main gelatin types provided by Gelita for the manufacture of soft capsules are:

* limed bone or limed hide gelatin, 150-175 bloom

* acid pigskin gelatin, 190-210 bloom

* a blend of limed bone and limed hide gelatin, 150-170 bloom

* a blend of acid pigskin, limed bone and limed hide gelatin, 150-170 bloom.

Gelita's gelatin types for the production of hard capsules include:

* limed bone gelatin, 220-260 bloom

* a blend of limed bone and limed hide gelatin, 220-260 bloom

* a blend of limed bone, limed hide and acid pigskin gelatin, 220-260 bloom.

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Glatt Pharmaceutical Services

20 Spear Rd.

Ramsey, NJ 07446

Tel. 201.825.8700

www.glattair.com

Description

Glatt Pharmaceutical Services, a Division of Glatt Air Techniques, Inc., is a leading provider of solid-dosage form development and manufacturing services to the pharmaceutical industry, including proprietary drug delivery technologies available through specific license agreements. With many years of experience and innovation, Glatt has been partnering with pharmaceutical companies to bring both immediate and complex controlled-release products to market. Glatt is expanding its CGMP facility with additional processing systems and capabilities, including the processing with organic solvents. All of Glatt's services are provided with the greatest attention to quality and customer service.

Products and services

* formulation development

* process development

* clinical trial material production

* full-scale CGMP manufacturing

* process validation studies

* analytical testing

* client-site process consulting

* client-site process and operator training

* CPS[TM], a proprietary drug delivery technology

* Cellets[TM], MCC core spheres.

GlobePharma, Inc.

PO Box 10837

New Brunswick, NJ 08906-9998

Tel. 732.819.0381

Fax 732.777.5129

sanni@globepharma.com

www.globepharma.com

Description

GlobePharma is a supplier of new and used quality pharmaceutical equipment, specializing in unit-dose powder samplers.

Products and services

The products offered include unit-dose and bulk samplers for powders, liquids, and semisolids; tabletop rotary tablet presses; tablet-press instrumentation packages; tabletop blenders with interchangeable shells; powder flow and segregation testers; remote swabbing and microbiological sampling tools; cleaning-validation coupons; manual tablet compaction machines; semiautomatic capsule-filling machines; capsule polishers; empty-capsule eliminators; tablet de-dusters; tap density testers; disintegration test apparatus; friability testers; and used pharmaceutical equipment.

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Hach Ultra Analytics

481 California Ave.

Grants Pass, OR 97526

Tel. 541.472.6500 or 800.866.7889

Fax 541.479.3057

infodesk@hachultra.com

www.hachultra.com

Description

Hach Ultra Analytics creates advanced laboratory and process instrumentation for critical measurements in air, liquid, and gas, providing full compliance to the latest standards for leading pharmaceutical, biotechnology, and semiconductor companies around the world. Hach's legacy includes the combined industry experience of Anatel, Pacific Scientific Instruments, and Orbisphere.

Products and services

* Anatel TOC analyzers, offering USP <643> and <645> compliance and automated system suitability

* Met One particle counters with Long Life Laser technology have an average service life greater than 10 years

* Orbisphere ozone analyzers, industry-leading with proven accuracy

* Facility monitoring systems, combining its outstanding instrumentation with easy-to-use software for flexibility and easy compliance.

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HollisterStier Contract Manufacturing

3525 N. Regal St.

Spokane, WA 99207

Tel. 800.992.1120

Fax 509.484.4320

contract_mfg@hollister-stier.com

www.thinkhs.com

Description

HollisterStier Contract Manufacturing focuses on parenteral contract manufacturing services. Capabilities include aseptic liquid fill-finishing and lyophilization in three distinct areas: clinical trial manufacturing, small volume parenterals, and small-lot manufacturing for large- and small-scale projects. HollisterStier has an extensive background in fill-finishing and small-lot manufacturing. New services and products include a BOC Edwards 200 [ft.sup.2] lyophilizer and Bosch MRF 1010 filler.

Products and services

Products and services include fill-finishing; lynphilization; analytical and microbiological testing; validation; project management; and regulatory services. Clinical trial manufacturing:

* preclinical-phase III

* Jot sizes up to 5000 vials.

Small volume parenterals:

* phase I-commercial

* lot sizes up to 180,000 vials. Small lot manufacturing:

* phase I-commercial

* lot sizes up to 8000 vials.

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Honeywell Process Solutions

2500 W. Union Hills

Phoenix, AZ 85027

Tel. 877.466.3993

Fax 602.313.4040

www.acs.honeywell.com

Description

Honeywell Process Solutions is dedicated to serving the pharmaceutical and life science industries. Honeywell's mission is to improve its customers' business performance and peace of mind by delivering leading edge automation and control solutions, equipment, and services.

Products and services

With Honeywell, you can take control of processes and the environment in your regulated manufacturing facility. Honeywell's pharmaceutical solutions integrate best practices in key areas such as process control, building control, manufacturing execution systems, environmental monitoring, compliance, validation, and metrology-every cost center in your plant. Honeywell can help you achieve total enterprise integration and significantly improve your bottom-line performance.

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Horiba Instruments, Inc.

17671 Armstrong Ave.

Irvine, CA 92614

Tel. 949.250.4811

Fax 949.250.0924

labinfo@horiba.com

www.horiba.com

Description

Horiba Instruments is a global supplier of analytical instruments, including particle characterization analyzers and systems for the pharmaceutical and biotechnology markets. The equipment is backed by a full technical and applications support team to provide a complete solution to the user's requirements.

Products and services

Horiba Instruments offers a wide range of particle characterization analyzers, measuring particle sizes from 1 [micro]m to 30 mm, using a range of analytical techniques including light scattering and digital image processing. A range of accessories are available to optimize the system for the desired measurement or to automate the analysis task.

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Hospira Inc.

275 N. Field Dr.

Lake Forest, IL 60045

Tel. 224.212.2267

Fax 224. 212.3210

one2one@hospira.com

www.hospira.com

Description

Hospira's One 2 One Global Pharmaceutical Services is a full-service parenteral contract manufacturer. One 2 One's approach focuses on developing a sound development and commercialization strategy then delivering your product to market as quickly as possible. One 2 One has a focus on long-term relationships that allow it to add or develop resources specific to your outsourcing strategy. Working with One 2 One also gives you peace of mind knowing that you have selected a contract manufacturer that has 70 years of experience with a continued focus on security of supply.

Products and services

One 2 One offers:

* vials, bottles, and ampules

* intravenous flexible containers

* prefilled syringes

* cartridges

* aseptic fill (SVP and LVP)

* terminal sterilization

* lyophilization including biologics

* controlled substances capabilities

* secondary packaging

* global regulatory support.

Facilities:

Five of One 2 One's plants in the United States and one in Europe combine to provide a global solution to contract manufacturing needs.

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Huber Engineered Materials, part of J.M. Huber Corporation

907 Revolution St.

Havre de Grace, MD 21078

Tel.410.939.7251 (inside sales)

Fax 410.939.7313

hubermaterials@huber.com

www.rxcipients.com

Description

Huber is a manufacturer of excipients and inorganic specialty powders for use as fast dissolve promoters, glidants, and carriers. The company also specializes in granulation for tableting for oral dosage forms.

Products and services

Rxcipients advanced pharmaceutical excipients are precisely engineered to ensure formulation quality in oral dosage formulations.

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International Centre for Diffraction Data

12 Campus Blvd.

Newtown Square, PA 19073

Tel. 610.325.9814

Fax 610.325.9823

marketing@icdd.com

www.icdd.com

Description

With 63 years serving the scientific community, the International Centre for Diffraction Data (ICDD), a not-for-profit corporation, is dedicated to the collection, editing, and publication of the Powder Diffraction File (PDF). The ICDD's mission is to be the world center for quality diffraction data meeting the needs of the technical community.

Products and services

PDF-4/Organics 2005 database contains 265,208 organic and organomettalic entries. It is designed for rapid materials identification targeted for the pharmaceutical and specialty chemical industries. Its design allows for easy interface with diffractometers and data analysis systems of leading software developers and manufacturers of X-ray equipment. The database is useful for scientists working in consumer products, catalysis, forensic science, analytical laboratories, drug discovery, and production.

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Ionics Instruments

6060 Spine Rd.

Boulder, CO 80301

Tel. 800.255.6964 or 303.444.2009

Fax 303.444.9543

marketing@IonicsInstruments.com

www.IonicsInstruments.com

Description

Ionics Instruments is a leading manufacturer of instruments used to measure total organic carbon (TOC) in pharmaceutical water. Pharmaceutical companies worldwide rely on the company's highly sensitive, selective, easy-to-use, Sievers[R] brand TOC Analyzers. Applications include monitoring waters for USP, ER or JP compliance, and sampling for cleaning validation, integrated or add-on 21 CFR Part 11 compliance support software also is available.

Products and services

Ionics Instruments offers:

* Sievers line of TOC Analyzers, including the new 900 Series (900 Laboratory, 900 On-Line, 900 Portable, and 900 Autosampler) and the 400 ES On-Line Pharma

* Sievers DataGuard[TM] software for 21 CFR Part II compliance

* Sievers Certified Reference Materials (TOC and conductivity standards)

* Extensive instrument training, technical support, validation support packages, and preventive maintenance contracts.

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Johnson Matthey Pharmaceutical Materials--USA

2003 Nolte Dr.

West Deptford, NJ 08066

Tel. 800.444.8544

Fax 856.384.7276

jmpharma@jmusa.com

www.jmpharma.com

Description

Johnson Matthey Pharmaceutical Materials Division is a foil service provider of active pharmaceutical ingredients.

Johnson's production unit in West Deptfbrd, New Jersey, is registered with FDA and DEA for the manufacture of APIs. It provides contract process scale-up and large scale CGMP manufacturing services to both generic and branded products.

Johnson's research and development unit, Pharm-Eco, with facilities in North Andover and Devens, Massachusetts, provides contract research, process development, and small-scale synthesis.

Johnson's European unit, Macfarlan Smith (located in Edinburgh, Scotland), is a world leader in the production of alkaloid opiates and other controlled drugs. It also has synthetic capabilities and facilities for the extraction and purification of APIs from natural products.

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Lancaster Laboratories, Inc.

2425 New Holland Pike, PO Box 12425,

Lancaster, PA 17605-2425

Tel. 717.656.2300

Fax 717.656.3772

pha@lancasterlabs.com

www.lancasterlabs.com

Description

Lancaster Laboratories, one of the nation's leading analytical testing laboratories, serves pharmaceutical and biopharmaceutical clients worldwide. Lancaster has delivered analytical laboratory services in chemistry and microbiology with exceLlent quality and service since 1961. With a large laboratory capacity, extensive technical expertise, and a multiple-shift staff, Lancaster can handle projects of any size.

Products and services

* drug substance and drug product stability testing and storage

* release testing and product retain programs

* excipient testing (USP/NF, EP, JP)

* container testing on plastic and glass (USP <6615>)

* extractables and leachates

* microbiology: sterile products, non-sterile products, facility, support testing

* analytical method development and validation

* comparator product testing

* consulting services.

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L.B. Bohle, Inc.

700 Veterans Circle, Suite 100

Warminster, PA 18974

Tel. 215.957.1240

Fax 215.957.1237

www.lbbohle.com

Description

L.B. Bohle has a proven reputation for meeting the development and manufacturing equipment needs of the pharmaceutical industry. Systems include laboratory- and production-scale high-shear and fluid bed granulators, bin-blenders, tablet coaters, mills, and mobile and stationary lifting units. Also available are a new BCG continuous granulator, an automatic vision inspection tablet checking system, and the BCS containment valve for potent product handling.

Products and services

Highlighted at the AAPS exposition will be the company's application of PAT for powder blending. Incorporated in a Bohle 10-KG laboratory-scale blender, the new fully integrated NIR System provides real-time monitoring of blend homogeneity and end-point determination during blending operations. Fluid bed systems and a laboratory-scale mobile tablet coater also will be exhibited along with other Bohle products.

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Lyne Laboratories

10 Burke Dr.

Brockton, MA 02301

Tel. 508.583.8700

Fax 508.583.9120

cms@lyne.com

www.lyne.com

Description

Lyne provides contract manufacturing services to large- and mid-size ethical pharmaceutical companies, small biotech start-ups, and virtual companies. Lyne specializes in the manufacture of liquids: syrups, solutions, suspensions, alcohol-based, and topical. Lyne also offers specialty packaging: dropper bottles, liquid unit-dose cups, and tubes. In addition, Lyne manufactures tablets, semisolids, and powders.

Lyne's services include clinical manufacturing (late stage), technical transfer, commercial manufacturing, analytical services, ICH stability programs, validation services, regulatory support for NDAs and ANDAs, and hospital unit-dose liquid packaging. Lyne is FDA and EPA registered, DEA licensed, and ISO 9001:2000 certified.

Lyne's outstanding regulatory history is matched by smooth and efficient product transfer and highly flexible, superior quality manufacturing services.

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Mallinckrodt Pharmaceuticals Outsourcing

172 Railroad Ave., PO Box P

Hobart, NY 13788

Tel. 607.538.9124 ext. 3109

Fax 607.538.9857

dale.dyer@tycohealthcare.com

www.mallinckrodt.com

Description

Mallinckrodt Pharmaceuticals Outsourcing is a contract manufacturer specializing in high-quality oral solid dose and oral liquid products. Mallinckrodt's diverse clientele ranges from leading established pharmaceutical companies to virtual and emerging ones. To date, Mallinckrodt has added more than 200,000 [ft.sup.2] of manufacturing and packaging suites, liquid-production capability, additional packaging lines, and several high-speed encapsulation and tablet presses. These investments in facilities and equipment have allowed Mallinckrodt to increase its capacity more than 500%. Mallinckrodt's facility also is FDA and DEA I-V compliant and operates under CGMP conditions.

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MDS Pharma Services

2350 Cohen Street

Montreal, Quebec

Canada

H4R 2N6

Tel. 514.333.0033

Fax 514.333.8861

info@mdsps.com

www.mdsps.com

Description

MDS Pharma Services offers a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotechnology industries: early stage including lead optimization, pre-IND research, early clinical research (bioequivalence, phases I-IIa) and bioanalysis; late stage including global clinical development (phases IIb-IV) and central laboratory.

Products and services

MDS Pharma Services Pharmaceutics leverages scientific expertise and novel technology across an integrated line of services to offer solutions at every stage of the drug discovery/development cycle. MDS services include:

* preformulation studies

* dosage form development

* analytical services

* clinical trial manufacturing

* product reformulation and life cycle management

* product stability and photostability

* microbiological services.

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MECO

1615 Poydras St., Suite 1400

New Orleans, LA 70112

Tel. 504.599.4000

Fax 504.599.4100

jfarrell@meco.com

www.mecobiopharm.com

Description

MECO is setting the standard in purified water and pure steam systems for the biopharmaceutical industry. Whether you need equipment, a specific service, or an entire water plant, MECO delivers. MECO's integrated team of engineers, craftsmen, and service professionals offers in-depth expertise with a focus on detail to ensure a quality solution-on time and on budget. The kind that earns MECO repeat business from major pharmaceutical companies.

Products and services

When it comes to big ideas for critical utilities, you can depend on MECO to deliver. Although MECO has a strong background in distillation, it has grown to provide expert guidance and proven solutions for every phase of water and pure steam generation. This includes all services and products related to:

* engineering design

* product manufacturing

* installation

* service

* validation.

The bottom line? MECO is an optimal choice whether you need assistance with one aspect of your purification system or you want an entire water plant designed and built from scratch.

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Microfluidics

30 Ossipee Rd.

Newton, MA 02464

Tel. 617.969.5452 or 800.370.5452

Fax 617.965.1213

mixinginfo@mfics.com

www.microfluidicscorp.com

Description

Microfluidics provides patented and proprietary high performance Microfiuidizer[R] materials processing equipment to the biotechnology, pharmaceutical, chemical, cosmetics/personal care, and food industries. Microfluidics applies its 20 years of high pressure processing experience to produce the most uniform and smallest liquid and suspended solid structures available, and has provided manufacturing systems for nanopartide products for more than 15 years.

Products and services

The company is a leader in advanced materials processing equipment for laboratory, pilot-scale and manufacturing applications, offering innovative technology, and comprehensive solutions for nanoparticles and other materials processing and production. More than 3000 systems are in use and afford significant competitive and economic advantages to Microfluidics equipment customers.

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Micromeritics

One Micromeritics Dr.

Norcross, GA 30093-1877

Tel. 770.662.3633

Fax 770.662.3696

ussales@micromeritics.com

www.micromeritics.com

Description

Micromeritics was founded more than 40 years ago to fulfill the analytical instrumentation needs of companies in the emerging field of particle science and technology. With US corporate headquarters in Norcross (Atlanta), Georgia, tile company has direct offices in England, Germany, Belgium, France, Italy, and China. In addition, the company's customers are served by a representative network covering more than 65 countries and worldwide service and applications support. Micromeritics is ISO 9001:2000 certified and offers software that addresses 21 CFR Part II requirements.

Products and services

Micromeritics manufactures automated analytical laboratory instruments that measure the physical characteristics of powders and solids for R&D, QA/QC, production, and process control applications. Characteristics measured include particle size, surface area, pore volume, pore size and pore size distribution, absolute density, envelope density, bulk density, chemisorption, and TPD/TPR. Micromeritics also has a materials analysis laboratory that provides sample analysis on a contract basis.

Micron Technologies Inc.

435 Creamery Way

Exton, PA 19341

Tel. 610.425.5100

Fax 610.425.5104

bhausner@microntechnologies.com

www.microntech.com

Description

Micron Technologies offers contract particle-size reduction and analytical services exclusively for the pharmaceutical industry. With two modern, directly compatible facilities in the United Kingdom and the United States, Micron Technologies offers global capabilities. Primary capabilities include micronization in addition to other particle-reduction techniques new pinmilling.

Products and services

Micron offers the capability to micronize gram, kilo, and ton quantities. Processing takes place in segregated independent isolated suites, providing the ability to handle controlled substances and potent and cytotoxic compounds. Contract analytical services include material characterization (XRD, surface area, and particle size), release testing, stability testing, and method development and validation. Both facilities are FDA inspected and operate under CGMP regulations.

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Mikart, Inc.

1750 Chattahoochee Ave.

Atlanta, GA 30318

Tel. 404.351.4510

Fax 404.350.0432

sales@mikart.com

www.mikart.com

Description

Since 1975, Mikart has been a recognized leader in contract pharmaceutical manufacturing. Mikart specializes in the development, manufacturing, and packaging of solid dose and liquid oral dose products. Mikart's services include formulation development; analytical, manufacturing, packaging, regulatory services; and complete project management.

Products and services

* formulation development

* analytical methods development

* methods and process validation

* stability testing

* clinical supplies packaging

* immediate- and controlled-release tablet manufacturing

* capsule manufacturing

* oral liquid manufacturing

* CII-CV controlled drug manufacturing film coating

* solid dose and liquid bottle packaging

* laminated foil pouch packaging

* regulatory services.

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Monarch Analytical Laboratories, Inc.

349 Tomahawk Dr.

Maumee, OH 43537

Tel. 419.897.9000

Fax 419.897.9111

testing@monarchlab.com

www.monarchlab.com

Description

Monarch Analytical Laboratories, Inc., is among the world's leading contract research laboratories for the analysis of pharmaceutical and medical packaging, plastics, and glass materials. Monarch's business is solving problems through the chemical analysis and testing of materials. Monarch is accredited to ISO 17025 standards and registered with FDA and DEA.

Products and services

Monarch is a CGMP laboratory specializing in the analysis of packaging leachables and extractables. Monarch performs testing for packaging control according to CFR, USP, EP, and custom protocols. Monarch develops and validates analytical methods for stability-release testing;, identification, and other pharmaceutical-related purposes.

Monarch serves the pharmaceutical packaging and medical device markets. Monarch supplies contract analytical chemistry services for research, methods validation, and stability testing for packaging control.

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Morflex, Inc.

2110 High Point Rd.

Greensboro, NC 27403

Tel. 336.292.1781

Fax 336.854.4058

skennedy@morflex.com

www.morflex.com

Description

Morflex, Inc. is a global leader in Citroflex[R] citric acid esters. Morflex is a member of SOCMA and has maintained ISO 9001 registration since 1994. Morflex started in 1927, when the company was founded as Morton Chemical Company. Today, Morflex operates as a wholly owned subsidiary of Reilly Industries. Morflex offers complete toxicological, technical, and regulatory support.

Products and services

Morflex, Inc. manufacturers a series of esters that perform as excipient plasticizers in pharmaceutical coatings. The esters include four citrates and one sebacate. The plasticizers have excellent compatibility with resins for controlled release of drug actives in solvent and aqueous formulations. The release profile may be customized by selection of a plasticizer with desired solubility characteristics. The plasticizers offer excellent enteric coating protection in acidic media with improved toughness and strength.

Morflex pharmaceutical-grade plasticizers are manufactured in compliance with CGMP guidelines and meet requirements of their respective compendial monographs.

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MOVA Pharmaceutical Corporation

PO Box 8639

Caguas, Puerto Rico 00726

Tel. 800.468.5201,787.258.1661, 787.746.8500

Fax 787.258.6405

busdev@movapharm.com

www.movapharm.com

Description

MOVA has more than 15 years of experience in the pharmaceutical industry and has earned the trust of leading pharmaceutical companies and emerging biotechnology companies as a high-quality provider of pharmaceutical manufacturing and product development services.

MOVA can perform selected activities in the manufacturing process and serve as a one-stop shop for converting raw materials into your finished product, ready for timely distribution.

Products and services

Manufacturing services include

* raw materials procurement

* raw materials testing

* full-scale testing

* product release testing

* stability testing

* regulatory services

* project and data management

* process improvement.

MOVA has three manufacturing facilities, totaling 840,000 [ft.sup.2], that provide services for solid, liquid, and sterile dosage forms; solvent solutions; controlled substances; bottle and blister packaging; cephalosporin solid dosage forms; and development.

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Natoli Engineering Company, Inc.

28 Research Park Circle

St. Charles, MO 63304

Tel. 636.926.8900

Fax 636.926.8910

marketing@natoli.com

www.natoli.com

Description

Natoli manufactures punches and dies with quality and cost in mind. Natoli's valuable experience and ability to troubleshoot gives it the ability to improve on original designs. Natoli is confident in its commitment to continually offer its customers the newest technological advances at a fraction of the expected cost.

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Nelson Laboratories, Inc.

6280 S. Redwood Rd.

Salt Lake City, UT 84123

Tel. 800.859.7594

Fax 801.963.2630

sales@nelsonlabs.com

www.nelsonlabs.com

Description

Nelson Laboratories is a premiere test services provider. Its services include more than 400 microbiological and analytical tests ill its state-of-the-art laboratory. Nelson welcomes clients and auditors to visit its facility and see for themselves the excellent quality and test systems it has to offer.

Products and services

For the pharmaceutical industry Nelson specializes in: microbiology, sterilization validations, lot release tests (e.g., sterility, bioburden, B/F, pyrogen), biocompatibility, filter validations, disinfectant validations, and much more. Nelson has 80 laboratories and offers both cleanroom and isolator facilities for product sterility testing within its 62,000 [f.sup.2] facility.

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Niro Inc.

9165 Rumsey Rd,

Columbia, MD 21045

Tel. 410.997.8700

Fax 410.997.5021

info@niroinc.com

www.niroinc.com

Description

Niro offers a comprehensive and innovative range of pharmaceutical processing equipment and systems that are designed and manufactured in house.

Products and services

Solid processing:

* spray dryers and congealers

* fluid-bed processors

* tablet presses

* high-shear granulators

* containment valves and systems

* intermediate bulk containers

* tumble mixers and blenders

* extruders and spheronizers.

Liquid processing:

* high-pressure pumps and homogenizers

* cross-flow membrane filtration systems

* evaporators

* CIP systems.

Services:

* product (and process) development and testing

* process integration and automation

* documentation and validation

* custom fabrication

* installation, commissioning, and training

* after-sales service and spare parts.

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Northview Biosciences, Inc.

Northbrook, IL

Hercules, CA

Spartanburg, SC

Tel. 847.564.8181

Fax 847.564.8269

info@northviewlabs.com

www.northviewlabs.com

Description

Northview is an independent laboratory that has been providing high-quality GMP and GLP testing services to biotechnology, biopharmaceutical, pharmaceutical, and medical-device manufacturers since 1972. Northview's experienced and conscientious staff of more than 160 professionals is dedicated to providing reliable testing and fast results with rigorous quality assurance. Northview is known for its friendly, responsive customer service, and encourages direct communication between clients and technical staff. All Northview facilities are FDA registered and ISO certified by BSI. Its toxicology facilities are AAALAC accredited.

Products and services

* GMP-GLP testing services

* analytical chemistry

* method development and validation

* stability studies

* USP, EP, JP testing

* container-closure testing

* microbiology

* LAL testing

* water system validation

* preclinical toxicology

* pharmacokinetics (ADME).

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Noveon, Inc.

9911 Brecksville Rd.

Cleveland, OH 44141

Tel. 800.379.5389 or 216.447.5000

Fax 216.447.5740

www.pharma.noveoninc.com

Description

Noveon, Inc., is a global chemical company with a world-class R&D organization that provides innovations in chemical technology. The pharmaceutical business unit supplies a versatile line of pharmaceutical ingredients in three categories: pharmaceutical excipients, actives-intermediates, and custom manufacturing.

Products and services

Noveon offers various grades of Carbopol polymers, Noveon polycarbophils, and Pemulen polymeric emulsifiers, which are cross-linked acrylic acid polymers used in the pharmaceutical industry for various applications.

Carbopol polymers are used to thicken topical lotions, creams, and gels, thereby providing rheology control, elegant skin feel, and consistent drug delivery. Noveon polycarbophil is a bioadhesive component for products that require extended mucosal contact. Pemulen polymeric emulsifiers are used to form stable oil-in-water emulsions with essentially no need for surfactants.

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O'Hara Technologies Inc.

20 Kinnear Ct.

Richmond Hill, ON L4B 1KB Canada

Tel. 905.707.3286

Fax 905.763.6749

sales@oharatech.com

www.oharatech.com

Description

O'Hara is a designer and manufacturer of tablet coating systems and related process equipment for the global pharmaceutical, nutritional, and confectionery markets. O'Hara offers totally integrated systems to include air handling units, spray systems, and dust collection, all with the required level of controls necessary to meet product and production requirements.

Products and services

* tablet coating systems with perforated drums range from 36 to 70 in.

* laboratory coating systems with drum sizes from 10 to 30 in. including three or four interchangeable drums

* tray-drying ovens from 100 to 400 K

* V-shell and conical blenders

* fluid bed dryer granulators, available in both laboratory and production sizes

* conventional coating pans and spray systems.

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OSG Norwich Pharmaceuticals, Inc.

6826 State Highway 12

Norwich, NY 13815

Tel. 607.335.3000

Fax 607.335.3100

info@norwichpharma.com

www.norwichpharma.com

Description

OSG Norwich Pharmaceuticals provides outsourcing solutions to the pharmaceutical industry in the areas of manufacturing, packaging, and quality services. OSG Norwich has the knowledge and capabilities of a large pharmaceutical manufacturer supported by a unique culture of accountability and focus on the customer's needs. This combination of skills and values makes the company last, flexible, and capable to bring products to market with maximum efficiency, quality, and consistency. OSG provides services for development through commercial launch and has a 117-year pharmaceutical heritage. OSG's plant is 27-years-old, has 375,000 [ft.sup.2] of space, and is fully capitalized. OSG does not market any of its own products and is routinely audited by its customers, FDA, and MHRA, with excellent results.

Products and services

* manufacturing and packaging

* development, clinical, commercial

* tablets and capsules

* liquids and semisolids

* PK, Bohle, and tote blending

* fluid bed and high shear

* bottles, blisters, and carding

* intermediate potency

* schedule II, III, IV, and V

* analytical, stability, micro

* MRP II, SAP, and metrics.

Pall Life Sciences

2200 Northern Blvd.

East Hills, NY 11548

Tel. 800.717.7255 or 516.484.5400

Fax 516.801.9548

biotech@pall.com

www.pall.com

Description

Pall is a leading global provider of filtration, purification, and separation techno]ogles to the diverse and rapidly expanding life sciences market. Its products are used from the earliest stages of discovery and development of new drugs, through production and delivery of therapies for the prevention, diagnosis and treatment of disease.

Products and services

Pall designs and installs automated systems for every aspect of filtration, separation, and purification. Pall engineers systems tot applications that require automation of multiple direct flow cartridge filters, plate-and-frame sheet filters, centrifugal discharge systems, integrated crystallizer filter dryers, as well as for separations applications that use tangential flow filtration separation systems. Automated chromatography and filtration systems provide process repeatability and allow monitoring of critical process conditions.

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Pharmadule Inc.

500 Hills Dr.

Bedminster, NJ 07921

Tel. 908.470.1023

Fax 908.470.1024

www.pharmadule.com

Description

Since 1986, Pharmadule, a division of Pharmadule Emtunga, has supplied nearly 50 high-tech modular facilities to the biotech and pharmaceutical industry worldwide. The head office is located in Stockholm, Sweden, and a sales office in New Jersey. The company has three production sites in the southwest region of Sweden.

Products and services

Pharmadule offers a quality and speed approach to fabricating pharmaceutical and biotech facilities. Quality is assured by using only prequalified components and equipment, installed by skilled and experienced craftsmen.

Construction time can be cut in half compared with conventional approach because of overlapping and parallel activities applied in our modular concept. Value is assured by a guaranteed fixed price.

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Pilgrim Software Inc.

2807 West Busch Blvd., Suite 200

Tampa, FL 33618

Tel. 813.915.1663

Fax 813.915.1948

info@pilgrimsoftware.com

www.pilgrimsoftware.com

Description

With more than 10 years of domain expertise, Pilgrim Software is a leading provider of Enterprise Quality and Compliance Management solutions. Pilgrim Software is a global organization headquartered in Tampa, Florida, with offices across North America, Europe and Asia.

Pilgrim's fully integrated solutions streamline corrective and preventive actions, complaint handling, document management and SOP enforcement, internal and external assessments, and employee training/certification processes.

Pilgrim solutions provide out-of-the-box industry best practices, enabling organizations to rapidly implement proven processes to ensure regulatory compliance and improve productivity. Pilgrim's solutions also are highly configurable to meet specific customer requirements.

With Pilgrim Software, organizations can drive continuous improvement across the entire enterprise, thus providing a distract competitive advantage, enhancing customer satisfaction and, ultimately improving shareholder value.

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Pyramid Laboratories, Inc.

3505 Cadillac Ave.

Building C

Costa Mesa, CA 92626

Tel. 714.435.9800

Fax 714.435.958S

info@pyramidlabs.com

www.pyramidlabs.com

Description

Pyramid Laboratories, Inc., is a state-of-the-art contract manufacturing and analytical service organization for the pharmaceutical and biotechnology industries. Pyramid's manufacturing services include formulation, processing, filling, and lyophilization capabilities for both liquid and syringe applications. Pyramid's team is experienced in product development, formulation, manufacturing, and in supporting laboratory services compliant with applicable GLP and CGMP guidelines. Pyramid's focus is on quality, performance, and integrity. Pyramid has a solid foundation in fundamental laboratory methodologies and techniques and has extensive experience in FDA compliance testing.

Products and services

* vial and syringe sterile fill-finish

* lyophilization capabilities

* product development-formulation

* in-process-final release testing

* method development-validation

* stability study services

* compliant with GLPs/CGMPs

* regulatory support.

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Quantitative Technologies, Inc.

291 Route 22 East, Salem Industrial Park,

Building 5 / PO Box 470

Whitehouse, NJ 08888

Tel. 908.534.4445

Fax 908.534.1054

Info@QTIonline.com

www.QTIonline.com

Description

QTI is an FDA- and DEA- registered contract analytical research and development laboratory, operating under CGMP regulations. QTI provides complete analytical solutions to the pharmaceutical, biotechnology, chemical, device, and diagnostic industries. Since 1989, QTI has supported approximately 80% of the world's top 50 pharmaceutical companies. QTI's services support all phases of drug development, from discovery through manufacturing.

Products and services

QTI's Pharmaceutical Support Division specializes in: method development and validation; stability studies including dissolution; revalidation of legacy drug methods; comprehensive reference standard characterization and requalification; comparator studies; cleaning validations; extractables and leachables; and release of finished products and clinical supplies.

QTI's Elemental Division specializes in: comprehensive elemental analysis for research and CGMP applications; trace metals analysis; identification and quantitation of inorganic components; toxicology screening; product profiling; release and stability; determining contaminants in packaging materials; and residue characterization.

Quintiles Consulting

1801 Rockville Pike, Suite 300

Rockville, MD 20852

Tel. 866.591.3966

Fax 301.272.2149

qcon.web@quintiles.com

www.quintiles.com/QuintilesConsulting

Description

Quintiles Consulting provides regulatory compliance and validation consulting services to the life science industries. Quintiles offers a unique combination of former government and industry experts to assure that what needs to get done gets done. Quintiles former FDA staff can provide an FDA perspective of your state of compliance combined with the extensive hands-on experience of industry veterans skilled in the practical aspects of implementing policies and procedures that meet regulatory requirements while meeting your company's business needs.

Products and Services

* quality system development and process optimization

* gap analyses, audits, and mock FDA inspections for GMP, QSR, GCP, GLP compliance with corrective action plan development and implementation

* validation consulting services including process validation, method validation, cleaning validation, software validation and 21 Part CFR 11 compliance

* training programs covering all aspects of GMP, QSR, GCP, GLP, validation, and FDA inspection readiness

* specializing in consent decrees, warning letters, and FDA-483 responses.

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Quintiles Preclinical and Pharmaceutical Sciences

10245 Hickman Mills Dr.

Kansas City, MO 64137

Tel. 816.767.3900,

Fax 816.767.3950

qkan.busdev@quintiles.com

www.quintiles.com

Description

Quintiles Preclinical and Pharmaceutical Sciences' discovery support and development services are based on state-of-the-art facilities and globally recognized expertise. Our pharmaceutical development, contract manufacturing, and clinical supplies facilities total more than 800,000 [ft.sup.2] in the United States and Europe.

Products and services

Quintiles offers a full range of custom-designed development services with professional standards. We have extensive experience in the formulation and process development of oral solids and liquids, semisolids, aerosols, and parenterals. Additional development services include analytical chemistry, stability testing, ADME, bioanalysis, DMPK, clinical PK-PD, safety, and general pharmacology and toxicology.

Quintiles offers full clinical manufacturing capabilities (aseptic/nonaseptic) and has the resources to expand small-scale processing for clinical batches into full-scale commercial production.

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Saint-Gobain Performance Plastics

3910 Industrial Drive

Beaverton, MI 48612

Tel. 989.435.9533

Fax 989.435.2355

biopharmmarketing@saint-gobain.com

www.biopharm.saint-gobain.com

Description

Saint-Gobain Performance Plastics is a leader in pioneering silicone extruded and molded products, fluoropolymer hoses, thermoplastic vessels and piping, and specialty engineered polymers. With such trusted brands as Sani-Tech[R], Tygon[R], Pure-Fit[R], Pharmed[R], SaniPure[TM], Pharmapure[TM] and Versilic[TM] the company's goal is to provide its customers with global solutions to critical applications.

Products and services

SaniPure[TM] 60 is clear, flexible tubing with unsurpassed biocompatibility that is heat sealable, bondable, weldable, and moldable for custom assembly fabrications. It has an ultra-smooth inner bore, superior peristaltic pump life, and is fully autoclavable and sterilizable. SaniPure[TM] 60 has low absorption rate and protein binding characteristics. It complies fully with the requirements of USP Class VI, EP 3.2.6, and FDA criteria.

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Sartorius Corporation

Biotechnology Division

131 Heartland Blvd.

Edgewood, NY 11717

Tel. 800.368.7178 or 631.254.4249

Fax 631.253.5428

www.sartorius.com

Description

Sartorius Corporation, headquartered in Goettingen, Germany, is an international market and technology leader in biotechnology. Sartorius's expertise covers applications for biomolecular and bioseparations, concentration, purification, fermentation, and cell culture technology from R&D to process-scale applications. Sartorius's production facilities, called Plant 2001, are setting global standards for the high-quality manufacture of separation products. The facilities are designed according to our integrated cleanroom concept to meet the current and future quality requirements of the biotech industry.

Products and services

Sartorius filter products are critical components in the CGMP-regulated production processes of its customers in the biotechnology industry. Plant 2001 represents a new dimension in membranefilter production and fulfills current and anticipated future quality and hygiene requirements of the biotechnology industry. Plant 2001 means state-of-the-art production, increased capacity, highly skilled and trained personnel, and an advanced organization to serve the growing needs of the biotechnology industry.

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Schwarz Pharma Manufacturing, Inc.

1101 C Ave.West

Seymour, IN 47274-0328

Tel. 800.457.9856 ext. 490

kdavis@schwarzusa.com

Description

Schwarz Pharma Manufacturing's GMP manufacturing facility in Seymour, Indiana, consists of 280,000 [ft.sup.2] of manufacturing, warehouse, laboratory, and office space. Schwarz has the facility, equipment, professional and experienced staff, and the commitment to be a full-service contract manufacturer. The company's services include all phases of manufacture, from product development to the distribution of your product. Schwarz can assure you of a well-trained team, modern facilities, and product quality that meet your specifications.

Products and services

Product capability

* tablets

* capsules.

Packaging capability

* solid dose

* kit assembly.

Support activities

* product development

* clinical trial materials

* analytical method development

* regulatory

* stability

* warehousing and distribution.

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Sensient Pharmaceutical Technologies

107 Wade Ave.

South Plainfield, NJ 07080

Tel. 908.757.4500

Fax 908.754.3222

sensient-pharma@sensient-tech.com

www.sensient-tech.com

Description

Sensient Pharmaceutical Technologies has been a leading provider of colors for more than 90 years. Sensient has taken its basic color knowledge and grown into a leading tablet coating manufacturer. With offices all over the world, Sensient has a broad knowledge of the global pharmaceutical markets and can find suitable color and coating to solve tablet coating needs.

Products and services

In addition to being the largest color manufacturer in the world, Sensient offers a line of coating systems including Spectrablend[TM], the complete film coating system. Also available is Spectracel[TM] HPMC for creating a variety of viscosities to suit your formulation and Spectracyl[TM] for methacrylic acid copolymers.

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SGM Biotech, Inc.

10 Evergreen Dr., Suite E

Bozeman, MT 59715

Tel. 406.585.9535

Fax 406.585.9219

info@sgmbiotech.com

www.sgmbiotech.com

Description

SGM Biotech is a global supplier of-biological indicators for use in validation and monitoring routine sterilization processes in the production of sterile pharmaceutical and medical devices.

Products and services

SGM Biotech offers a complete line of biological indicators for steam, ethylene oxide, hydrogen peroxide, and custom sterilization needs. D-value studies also can be performed on your pharmaceutical products and medical devices. Bin logical indicators integrate all the physical parameters of the sterilization process and are required by international standards.

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Shionogi Qualicaps, Inc.

6505 Franz Warner Parkway

Whitsett, NC 27377

Tel. 336.449.3900

Fax 336.449.3333

info@qualicaps.com

www.qualicaps.com

Description

Shionogi Qualicaps is a global manufacturer of empty two-piece hypromellose (HPMC) and gelatin capsules used in the pharmaceutical and biotech industries. Shionogi Qualicaps also has its own product line of capsule-filling equipment and sealing technologies, positioning the company as a full-service provider for the solid dosage industry. With locations around the world, Shionogi Qualicaps is positioned to meet the global demand for two-piece capsules.

Products and services

* Quali-V[R] capsules: HPMC nongelatin two-piece capsule alternatives with superior dissolution properties

* liquid filling capabilities: Shionogi's capsules and encapsulation equipment allows encapsulation of semisolids, pastes, oils, and liquids into two-piece capsules

* FS machine: fully automated capsule filling and sealing machine featuring an enclosed automatic transfer system which immediately delivers filled capsules directly into the sealing machine.

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Smiths Detection

30 Technology Dr.

Warren, NJ 07059

Tel.908222.9100

Fax 908.222.0586

lifesciences@smithsdetection.com

www.smithsdetection.com

Description

Smiths Detection develops and manufactures trace detection equipment based on ion mobility spectrometry. The accuracy and dependability of our products have made us a worldwide leader in the detection of explosives at airports. In addition, this state-of-the-art technology is used in pharmaceutical and chemical markets for cleaning validation and quality control.

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SOTAX Corporation

411 Caredean Dr., Suite A

Horsham, PA 19044

Tel. 215.442.1500

Fax 215.442.1514

sotaxusa@sotax.com

www.sotax.com

Description

SOTAX has specialized in developing and manufacturing sophisticated tablet dissolution and physical testing equipment for more than 30 years. SOTAX focuses on very high quality standards in all levels of operation and is continuously improving the quality of its systems. Directly represented in 8 countries (e.g. Canada and United States) and with a comprehensive distributor network, SOTAX's presence is worldwide.

Products and services

Dissolutions systems for USP 1-6 methods range from manual through semiautomatic to fully automated models. The brand new ceramic-headed model CP 7 piston pump has been designed to meet the ever-changing needs of today's dissolution user. In addition to testers for disintegration, friability, tap density, and powder flow, SOTAX has recently introduced a unique line of hardness testers.

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Southern Testing & Research Laboratories

3809 Airport Dr.

Wilson, NC 27896

Tel. 252.237.4175

Fax 252.237.9341

www.southerntesting.com

Description

Southern Testing & Research is a full-service contract analytical laboratory with more than 100 chemists, microbiologists, and support personnel providing personalized service for the pharmaceutical industry. Capabilities also include foods and feeds, environmental, agricultural, and microbiological sciences. The company's GLP-CGMP laboratory is FDA inspected and uses USP, EP, JP, BP, FCC, client, and in-house validated methods.

Products and services

Southern offers a full range of analytical support--from preclinical to postapproval. Southern has a broad range of expertise in analytical development, release testing, and stability testing. Capabilities include HPLC with UV/vis, diode array, fluorescence, ELSD, and detection; GC with FID, TCD, ECD, FPD, NPD, and ELCD detection; GC/MS, HPLC/MS, ICP/MS, AA, and ICP. GC capabilities include headspace analysis.

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Sparta Systems, Inc.

Holmdel Corporate Plaza

2137 Highway 35

Holmdel, NJ 07733

Tel. 732.203.0400 or 888.261.5948

Fax 732.203.0375

sales@sparta-systems.com

europe-sales@sparta-systems.com

www.sparta-systems.com

Description

Founded in 1994, Sparta Systems, Inc. is an enterprise software manufacturer that has developed leading edge, 21 CFR Part 11-compliant quality management system software for logging, tracking, reporting, and trending of all quality assurance and GxP compliance needs. Its product, TrackWise[R], has been a leading solution for the FDA-regulated industries since 1998. TrackWise is an off-the-shelf, fully configurable system, which offers businesses a versatile, powerful, and proven solution for all compliance needs. With the wide acceptance of its products and services, Sparta Systems has been expanding rapidly, adding products, solutions, and services in the United States, Europe, and the Far East.

Products and services

Along with maintaining technological leadership, Sparta Systems has been providing its customers with its proven professional services based on best practices it has acquired in the industry since 1998. Sparta's team has been involved in numerous project rollouts, providing services to ensure efficient deployment, facilitating all aspects of implementation, from requirements definition, through installation, configuration, and assistance during validation. (Sparta Systems also offers a complete IQ/OQ validation documentation package.)

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Specialty Measurements Inc.

1309 Route 22 East

Lebanon, NJ 08833

Tel. 908.534.1500

Fax 908.534.1546

mkulawiec@smitmc.com

www.smitmc.com

Description

A leader in compaction instrumentation since the introduction of its first system in 1984, SMI continues to advance the technology of solid dosage equipment in tablet presses, granulators, roller compactors, extruders, and encapsulators. SMI produces the finest, most cost-effective, solid dosage equipment for R&D through production in today's pharmaceutical marketplace.

Products and services

* tablet presses

* roller compactors

* granulators

* data acquisition systems

* formulation development

* calibration

* validation

* engineering/consulting

* new 1-mm R&D tablet press.

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STS duoTEK, Inc.

7500 W. Henrietta Rd.

Rush, NY 14543

Tel. 800.836.4850

Fax 585.533.1796

info@stsduotek.com

www.stsduotek.com

Description

For more than 25 years, STS has been serving the medical device and pharmaceutical industries through an array of testing and support services. STS experts serve clients one-on-one to ensure that marketing and regulatory needs are met efficiently and effectively. From research to release, our core services include laboratory testing, material qualification, biocompatibility, validation and sterilization, regulatory approval, and release testing. Biological indicators and manufacturing support add even greater value.

Circle/eINFO 335

Teledyne Tekmar

4736 Socialville Foster Road

Mason, Ohio 45040

Tel. 800.874.2004

Fax 513.229.7050

tekmarinfo@teledyne.com

www.teledynetekmar.com

Description

Teledyne Tekmar provides cutting-edge instruments for Pharmaceutical Applications including residual solvent and organic volatile impurity analysis, and cleaning validation and water-for-injection. More than just productivity-enhancing instruments, we provide the expert support you need to take the worry out of cleaning validation and other pharmaceutical quality processes.

Products and services

The rugged and dependable 7000HT static headspace system accurately identifies residual solvents and organic volatile impurities in bulk pharmaceuticals and excipients as prescribed in US Pharmacopeia <467>.

The Phoenix 8000[TM] meets detection limit requirements while providing a true TOC measurement for standardization and validation. TOC analysis with NDIR detection provides the flexibility to do cleaning validation and water-for-injection analysis in half the time versus other TOC analyzers.

Circle/eINFO 336

TELSTAR USA, Inc.

Three Neshaminy Interplex, Suite 301

Trevose, PA 19053

Tel. 215.245.2280

Fax 215.245.2281

jtconnor@etelstar.com

www.etelstar.com

Description

Founded in 1964 at Terrassa (Spain), the TELSTAR INDUSTRIAL headquarters remain there today as the company continues to expand and accept the newest challenges in the market. Rapid growth over the last five years now places TELSTAR INDUSTRIAL into the forefront as a truly international firm with stature among the finest systems manufacturers in the world. TELSTAR INDUSTRIAL conducts business globally, in over 250 countries, with branch offices in Pennsylvania (USA), Beijing and Hong Kong (China) and Belmont (Switzerland).

Products and services

Throughout the pharmaceutical and biotech industries, Telstar lyophilizers are now the systems of choice for a wide range of applications in lyophilization.

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Thermo Electron Corp.

81 Wyman Street

Waltham, MA 02454-9046

Tel. 877.THERMOU or 781-622-I 000

Fax 781.622.1207

sales@thermo.com

www.thermo.com

Description

Thermo Electron enables customers to advance scientific knowledge and to improve manufacturing processes with analytical instruments, laboratory equipment, software, and services. Thermo offers application solutions for drug discovery and development, pharmaceutical testing, quality control, and production.

Products and services

* chromatography/mass spectrometry

* robotics and laboratory automation

* sample preparation/liquid handling systems

* controlled environment laboratory equipment

* elemental analysis instruments

* informatics and software solutions

* clinical chemistry equipment and supplies

* professional laboratory services in volving installation, compliance, data management, project management, training, financing, asset management, and site assessment.

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Tunnell Consulting

900 E. 8th Ave., Suite 106

King of Prussia, PA 19406

Tel. 610.337.0820

Fax 610.337.1884

tunnell@tunnellconsulting.com

www.tunnellconsulting.com

Description

Tunnell Consulting, founded in 1962, integrates technical, process, business, and organizational skills to boost the operating performance of manufacturing and service firms with a focus in the pharmaceutical industry. Tunnell has a highly credentialed staff of scientists, engineers, and technical experts who help the pharmaceutical industry meet regulatory, legislative, and competitive demands.

Products and services

Tunnell is a full-service firm offering expertise in the areas of

* PAT and process capability and control

* QA and regulatory compliance

* process and method development and validation

* technology transfer

* product development

* manufacturing and production support

* quality laboratory and analytical support

* process improvement

* organizational change

* education and training

* project management

* supply chain optimization

* distribution systems and modeling.

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UPM Pharmaceuticals, Inc.

6200 Seaforth St.

Baltimore, MD 21224

Tel. 410.843.3738

Fax 410.633.4438

ryzenga@upminc.com

www.upm-inc.com

Description

UPM is a contract provider of technical formulation services, preclinical and clinical manufacturing, and analytical services for our pharmaceutical and biotechnology clients. The company serves development-stage drug discovery companies, biotech start-ups, and established pharmaceutical companies. UPM is distinguished by creating innovative solutions to drug formulation challenges using our proprietary formulation and drug delivery technologies. UPM's contract services and intellectual property both expedite product development and extend product life cycles.

Products and services

Capabilities include formulation and process development, analytical development and validation, preclinical and clinical CGMP manufacturing, CGMP release, stability-testing, and related QA and regulatory services. UPM specializes in solid dosage forms, including immediate- and extended-release tablets and capsules; oral liquids, including suspensions, emulsions, and solutions; and semisolids.

UPM also offers characterization, formulation, and analytical development for proteins and peptides. UPM's facility is DEA-certified for controlled drug substances, and equipped to handle high-potency compounds.

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Veltek Associates, Inc.

15 Lee Blvd.

Malvern, PA 19355-1234

Tel. 610.644.8335

Fax 610.644.8336

via@sterile.com

www.sterile.com

Description

Veltek Associates, Inc. is an EPA- and FDA-registered manufacturing facility with four divisions: sterile chemical manufacturing, environmental control monitoring, disposable products manufacturing, and VAI Laboratories, which has serviced the pharmaceutical, biotechnology, semiconductor, and electronics industries for more than 23 years.

Products and services

Production consists of a complete range of sterile pharmaceutical-grade disinfectants, sporicides, lubricants, buffer solutions, hand sanitizers, environmental monitoring systems, sprayer-mop-fogger systems, disposable garments, and textile products. Other services include consulting, laboratory testing, and worldwide distribution.

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Viscotek Corp.

15600 W. Hardy Rd.

Houston, TX 77060

Tel. 800.375.5966 or 281.445.5966

Fax 281.9331.4336

sales@viscotek.com

www.viscotek.com

Description

Viscotek Corporation was founded in 1983 by Dr. Max Haney, the inventor of the four-capillary differential viscometer detector. Since its inception, Viscotek has pioneered innovative technologies and products for the characterization of natural and synthetic polymers and proteins, allowing us to become a market leader in the manufacture of detectors and software for GPC/SEC/GFC/FPLC[R] applications.

Products and services

The triple detector array (TDA) is the first fully integrated TDA for maximum information with greater flexibility and fewer limitations. It combines a refractomer, viscometer, and light-scattering detector to determine absolute molecular weight, molecular structure, and molecular size ([less than or equal to] 1 nm). It is now available with low-angle light scattering for absolute molecular characterization without extrapolation or correction.

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VWR International

1310 Goshen Parkway

Westchester, PA 19380

Tel. 800.932.5000

solutions@vwr.com

www.vwr.com

Description

VWR International is a global leader in the distribution of scientific supplies, with worldwide sales of $2.8 billion. VWR's business is highly diversified across a spectrum of products and services, customer groups and geography. The company offers more than 750,000 products, from more than 5000 manufacturers, to more than 250,000 customers throughout North America and Europe.

Products and services

VWR International offers a wide range of laboratory and cleanroom chemicals, ,equipment, supplies, and global services to meet the diverse needs of research laboratories and production facilities. With more than 150 years experience in supply chain management, VWR provides access to the products, services, and technical support companies require to operate at peak efficiency.

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Watson-Marlow Bredel Inc.

37 Upton Technology Park

Wilmington, MA 01887-1018

Tel. 800.282.8823

Fax 978.658.0041

support@wmbpumps.com

www.watson-marlow.com

Description

For years, Watson-Marlow Bredel's pumping solutions have brought the highest degree of sterility and precision to pharmaceutical and biotechnology processes, ensuring zero contamination, easy cleaning, clean low-shear action, and reliability resulting in end product quality and integrity.

Watson-Marlow Bredel's peristaltic pumps are used in pharmaceutical and biotechnology applications, including bioreactors-fermentors; nutrient feed, harvesting, antifoam, perfusion, pH adjustment; ultrafiltration and diafiltration; chromatography; and media preparation.

Pumpsil[R], a platinum-cured silicone tubing featuring LaserTraceability[TM] sets the standard with absolute traceability. With full biopharmaceutical certification (USP Class VI, ISO10993) and Class J cleanroom manufacture, Pumpsil[R] offers high purity and clarity. Pumpsil[R] offers variations in bore size, wall thickness, reel length, and packaging, and is available to meet requirements for 50 or 50,000 ft and beyond.

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Weiler Engineering, Inc.

1395 Gateway Dr.

Elgin, IL 60123

Tel. 847.697.4900

Main fax 847.697.4944

Sales fax 847.697.4915

solutions@weilerengineering.com

www.weilerengineering.com

Description

Weiler Engineering, Inc is a leading provider of advanced aseptic liquid processing technology to the world's major pharmaceutical and healthcare companies. Weiler manufactures Asep-Tech blow-fill-seal systems, incorporating the three-step process of blow molding, aseptic filling, and hermetic sealing of liquid products in one sequential operation on a compact machine frame.

Products and services

The Asep-Tech model 640 blow-fill-seal machine from Weiler Engineering represents advanced aseptic liquid processing technology for injectable products and is ideally suited for high-volume production. The model 640 has the flexibility to produce complete sterile, liquid-filled, tamper-evident packages in sizes ranging from 0.5 to 500 mL.

Weiler also offers assistance with conceptual container design and prototyping and can provide integrated finishing lines for your full production needs.

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Wellspring Pharmaceutical

400 Iroquois Shore Rd.

Oakville, Ontario L6H 1M5 Canada

Tel. 866.337.4500

Fax 905.337.7239

salesinfo@wellspringpharm.ca

www.wpcoutsourcing.com

Description

WellSpring Pharmaceutical is a full-service provider of contract clinical and commercial manufacturing and packaging solutions for virtually all finished nonsterile solid and semisolid dose products, including tablets, capsules, creams, lotions, ointments, gels, and oral suspensions and solutions. WellSpring also provides clinical manufacturing, over-encapsulation, labeling, packaging, storage, distribution, and returned goods management to support its clients' most complex clinical trial requirements.

Products and services

WellSpring capabilities include blending, fluid bed granulation, tablet compression, encapsulation, film coating, and topicals and liquids processing to accommodate requirements of any size. Extensive packaging capabilities enable tablets or capsules to be bottled or blister-sealed in virtually any quantity or presentation. Liquids, creams, or ointments can be supplied in varying sizes of bottles, jars, tubes, and enema formats.

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West Pharmaceutical Services, Inc.

101 Gordon Dr.

Lionville, PA 19341

Tel. 610.594.2900 or 800.231.3000

Fax 610.594.3000

webmaster@westpharma.com

www.westpharma.com or

www.westdrugdelivery.com

Description

West designs and manufactures medical device and pharmaceutical packaging components using elastomer, metal, plastic, and multimaterial technologies.

Products and services

West's FluroTec[R] components meet the needs of today's high-performance drugs. West's LyoTec[TM] stoppers meet drug manufacturers' need for components that do not stick to lyophilization chamber shelves. West's D-I-D[R] buttons and seals meet industry need for anticounterfeiting pharmaceutical vial closures.

West's Westar RS[R] processing capabilities in the United States and Europe provides drug manufacturers with pharmaceutically clean, validated stoppers, and syringe components.

Through West's CGMP, FDA-registered analytical laboratory, customers have access to West's packaging expertise for the analysis of container closures and pharmaceutical packaging. West's global technical support services include elastomeric formulation and packaging recommendations, compatibility analysis, and extractable studies.

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Yamanouchi Pharma Technologies, Inc.

3300 Marshall Ave.

Norman, OK 73072

Tel. 888.236.5553

Fax 405.217.6561

info@ypharma.com

www.ypharma.com

Description

Yamanouchi Pharma Technologies, Inc. (YPT) is committed to discovering, developing, and commercializing novel drug delivery systems and providing contract manufacturing services to the pharmaceutical industry. Yamanouchi is meeting healthcare challenges and improving the quality of life for its customers through increasing convenience, compliance, and efficacy.

Products and services

YPT's current portfolio offers innovative solutions in proprietary oral solid dose technologies to enhance efficacy and improve patient compliance:

* "WOWTAB" quick-dissolving tablets

* "OCAS" oral-controlled absorption system

* "CODES" colon-targeted delivery system.

YPT's capabilities include: spray drying, taste masking, granulation, blending, tablet compression, tablet coating, capsule filling, technology transfer/scale up, full analytical and regulatory support, bottle and blister packaging, clinical and commercial manufacturing.

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COPYRIGHT 2004 Gale Group

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