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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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].
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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].
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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.
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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.
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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.
Circle/eINFO 275
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.
Circle/eINFO 306
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.
Circle/eINFO 307
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.
Circle/eINFO 308
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.
Circle/eINFO 309
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.
Circle/eINFO 310
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.
Circle/eINFO 311
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.
Circle/eINFO 312
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).
Circle/eINFO 313
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.
Circle/eINFO 314
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.
Circle/eINFO 315
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.
Circle/eINFO 317
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.
Circle/eINFO 318
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.
Circle/eINFO 319
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.
Circle/eINFO 320
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.
Circle/eINFO 322
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.
Circle/eINFO 323
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.
Circle/eINFO 324
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.
Circle/eINFO 325
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.
Circle/eINFO 326
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.
Circle/eINFO 327
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.
Circle/eINFO 328
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.
Circle/eINFO 329
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.
Circle/eINFO 330
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.
Circle/eINFO 331
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.
Circle/eINFO 332
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.)
Circle/eINFO 333
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.
Circle/eINFO 334
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.
Circle/eINFO 337
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.
Circle/eINFO 338
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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