Company Showcase
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3M Drug Delivery Systems Manufacturing Services
With more than 50 years of global pharmaceutical manufacturing experience, 3M Drug Delivery Systems is equipped to satisfy your inhalation and transdermal manufacturing requirements, including controlled substance (CII-CV) capabilities. With small order flexibility and cGMP compliant facilities capable of producing the necessary volumes from clinical through commercial supply, we have the capacity to meet your needs. Our supply chain management and lean six sigma expertise ensure timely delivery of products worldwide.
3M Center
St. Paul, MN 55144
Phone: 800-643-8086
Fax: 651-737-5265
Web: www.3M.com/dds
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Advinus Therapeutics
Advinus Therapeutics provides preclinical and early clinical drug development services to the pharmaceutical and biotech industry. We offer a comprehensive and integrated development platform from discovery to IND filing. Our capabilities include Process Chemistry, DMPK/Clinical Pharmacology, Regulatory Toxicology, Safety Pharmacology and Analytical R&D including Bioanalytical. We are GLP certified by the German, Dutch and Indian authorities. Advinus has the largest multi-species contract vivarium in India and has been AAALAC accredited since 2001.
21 & 22 Phase II, Peenya Industrial Area
Bangalore 560058, India
Phone: +91-80-28394959
Fax: +91-80-28394015
Email: bda@advinus.com
Web: www.advinus.com
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Agilent Technologies
Agilent Life Sciences and Chemical Analysis is a leader in instrumentation, supplies, software and services. LSCA generated about 37% of Agilent’s $5.4 billion of total revenue in 2007. Its 4,000 employees serve about 25,000 customers in 100 countries. Agilent’s laboratory workflow solutions are popular in life science research, pharmaceutical development, forensics, food safety, petrochemical processing and other critical applications. Core platforms are GC, GC/MS, LC, LC/MS, ICP-MS, DNA microarrays and microfluidic bioanalyzers.
2850 Centerville Road
Wilmington, DE 19808
Phone: 408-345-8886
Fax: 408-345-8474
Web: www.chem.agilent.com
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Almac
Almac has the most unique and extensive range of integrated drug development services available to the biopharmaceutical industry. Our world-class pharmaceutical solutions, used by over 600 companies worldwide, extend from research, through development to the commercialization of product. Our services range from R&D, diagnostic/microarray services, radiolabeling, API manufacture, formulation development, clinical supplies, IVRS/Web/EDC, commercial scale manufacture and supply chain management.
Almac House
20 Seagoe Industrial Estate
Craigavon, UK BT63 5QD
Phone: ++44(0)28 3833 2200 (Europe)
Phone: 610-666-9500 (U.S.)
Email: info@almacgroup.com
Web: www.almacgroup.com
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Aptuit
Aptuit is a company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators. We are the first provider to combine industry-leading drug development consulting expertise, state-of-the-art GMP/GLP facilities, innovative technologies designed specifically to expedite the development process, complete project management capabilities, and comprehensive regulatory compliance services, all in one package. Customers can select distinctive parts of the mix, or an end-to-end solution.
Two Greenwich Office Park
Greenwich, CT 06831
Phone: 816-767-3900
Fax: 816-767-3950
Email: info@aptuit.com
Web: www.aptuit.com
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Asahi Kasei Medical America
Asahi Kasei Medical America Inc. is the USA-based affiliate responsible for Planova Filters. Planova filters are the world’s first process filters designed specifically for virus removal by Asahi Kasei Medical. Used in commercial processes since 1989, Planova filters significantly enhance safety in biopharmaceuticals and plasma-derived therapeutics worldwide. Planova representatives can also speed-up your development steps with a free evaluation, laboratory visits, or assistance with your virus validations. We can provide consultation during process scale-up activities including filter sizing, skid design, and process integration. Asahi Kasei Medical is committed to manufacture all its products in a manner that is safe for our environment.
1600 Stewart Avenue, Suite 602
Westbury, NY 11590
Phone: 516-620-3130
Fax: 516-620-3135
Email: planova1@ak-america.com
Web: www.PlanovaFilters.com
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Aseptic Technologies
Aseptic Technologies has developed a new technology for aseptic filling: the ready-to-fill closed vial. The Crystal® closed vial is provided clean and sterile, with the stopper in place. Thanks to such container design, the most complex filling operations of classical open vials (vial washing, stopper washing, sterilization and stoppering) are simply eliminated. Filling of Crystal® closed vial is done by means of a specific needle that pierces the stopper and dispenses the liquid. After withdrawal, the puncture trace is immediately resealed with a laser to restore closure integrity.
Rue Camille Hubert 7
B-5032 Gembloux
Phone: +32 (0) 81 409 410
Fax: +32 (0) 81 409 411
Email: info@aseptictech.com
Web: www.aseptictech.com
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Asterand
Asterand plc is the leading global supplier of high quality, well characterized human tissue and human tissue-based research services to pharmaceutical researchers. Our mission is to provide human tissues and services to accelerate the identification and validation of drug targets and enhance the selection of drug candidates with an increased likelihood of clinical success.
440 Burroughs, Tech One, Suite 501
Detroit, MI 48202
Phone: 313-263-0960
Phone: +44(0) 1763-211-600
Fax: 313-263-0961
Email: advantage@asterand.com
Web: www.asterand.com
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Azopharma Product Development Group
Azopharma Product Development Group provides full product development and stand-alone services for the pharmaceutical, biotech and medical device industries. From preclinical to late phase development projects, Azopharma provides total product development services. Our capabilities include: Full IND Development; Full NCE Development; Full ANDA Development; and Full Medical Device Development. Please contact us to review your project requirements.
Two Oakwood Boulevard, Suite 170
Hollywood, FL 33020
Phone: 954-433-7480
Email: development@azopharma.com
Web: www.azopdogroup.com
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BASi
BASi provides contract research services and unique products for the pharmaceutical industry. BASi also provides contract services under FDA GLP and cGMP for drug metabolism, pharmacokinetics studies, pharmacology, toxicology, pharmaceutical product analysis, stability program support. Bioanalytical chemistry using the latest 96-well robotics, LC/MSMS (40 instruments) is one specialty. BASi works with laboratory animal models from mice to primates, supports all phases of human clinical trials, and is a leading manufacturer of specialized instrumentation for automated in vivo sampling, veterinary medicine and electrochemistry.
2701 Kent Ave.
West Lafayette, IN 47906
Phone: (765) 463-4527
Fax: (765) 497-1102
Web: www.bioanalytical.com
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Ben Venue Laboratories
Ben Venue Laboratories develops and manufactures sterile liquid and lyophilized products under contract. The company has expertise in handling complex formulations and has contributed to the creation of many significant pharmaceutical products for nearly 70 years. The company’s flexibility enables it to handle cytotoxic and non-cytotoxic products with batch sizes from pilot-scale to large production volume. Products from Ben Venue Laboratories are distributed globally. Ben Venue Laboratories is a wholly
owned subsidiary of Boehringer Ingelheim Corporation.
300 Northfield Rd., P.O. Box 46568
Bedford, OH 44146
Phone: (440) 232-3320
Fax: (440) 439-6398
Web: www.benvenue.com
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Bilcare
Bilcare Global Clinical Supplies serves the Americas, Europe, and Asia with clinical trial materials support, services and complete project management. Our services for solid, semi-solid, liquid, DEA (CI-V) and biotech clinical trial materials (CTM) satisfy a broad range of requirements; from pre-formulation research and development, analytical services and clinical supplies packaging and labeling, to IVRS, controlled temperature (cold and frozen chain) CTM storage, distribution worldwide, and returns and destructions
accountability. Our integrated approach provides you with seamless service throughout your entire project.
300 Kimberton Road
Phoenixville, PA 19460
Phone: 800-310-4445
Phone: 610-935-4300
Fax: 610-935-4321
Email: direct-gcs@bilcare.com
Web: www.BilcareGCS.com
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Catalent Pharma Solutions
Catalent Pharma Solutions is one of the leading providers of advanced technologies, as well as drug development, drug delivery, manufacturing and packaging solutions for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Let us be the catalyst for your product's success wherever you do business!
14 Schoolhouse Road
Somerset, NJ 08873
Phone: 866-720 3148
Fax: 732-537 6480
Web: www.catalent.com
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Chemic Laboratories
Chemic Labs is a contract chemistry organization, FDA registered and DEA licensed, servicing the pharmaceutical, medical device, biotech, veterinary medicine and specialty chemicals industries. We offer CMC method development and validation, extractables & leachables analysis, QC chemistry, bioanalytical sample analysis, cGMP organic synthesis & formulation and high purity excipient manufacturing.
480 Neponset St., Bldg. 7C
Canton, MA 02021
Phone: (781) 821-5600
Fax: (781) 821-5651
Web: www.chemiclabs.com
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CIRION Clinical Trial Services, Inc.
CIRION is a leading provider of Central Laboratory and Contract Research services. Our services and capabilities include a complete range of safety and specialized testing, assay development & validation services, project management and global logistics. With advanced scientific capabilities and experience in Phase I-IV trials, we provide a complete solution to meet the challenges of your clinical projects worldwide.
2121 Berlier St.
Laval, Quebec, Canada H7L 3M9
Phone: 866-688-2474
Fax: 450-902-3060
Email: businessdevelopment@cirion.com
Web: www.cirion.com
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Coating Place
Coating Place is a drug delivery systems, manufacturing and development company specializing in Wurster fluid bed coating. Services include formulation development, technology transfer, scale-up and commercial manufacturing with laboratory support. Our applications include controlled and sustained release, enteric and taste masked coatings. Our facilities process solvent and aqueous formulations. We are DEA registered. Send us your toughest projects.
200 Paoli St.
Verona, WI 53593
Phone: (817) 477-2766
Fax: (817) 453-1696
Web: www.encap.com
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Cook Pharmica
Cook Pharmica is a contract biopharmaceutical manufacturer and service provider located in Bloomington, Indiana. Cook Pharmica provides CGMP manufacturing for cell culture-based biopharmaceuticals as well as CGMP cell banking, cell bank storage and a wide array of development services for both mammalian and microbial systems. Our development services include: cell line/strain development, media optimization, molecular biology, scale-up and process development, purification development and analytical testing.
1300 S. Patterson Drive, PO Box 970
Bloomington, IN 47402-0970
Phone: 877-312-COOK
Email: busdev@cookpharmica.com
Web: www.cookpharmica.com
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CPL
CPL provides manufacturing, packaging and testing of liquid and semi-solid prescription and OTC pharmaceutical products with facilities located in Toronto, Canada and Buffalo, New York. Our expertise includes nasal sprays, applicator technology, and a variety of liquid and dermatological products. Our operations are FDA, Health Canada and EU inspected plus licensed for controlled substances. CPL executes projects from small scale clinical batches to commercial manufacturing and is focused on meeting the needs of each of our customers.
7600 Danbro Crescent
Mississauga, ON L5N 6L6
Phone: 905-821-7600
Fax: 905-821-7601
Web: www.cplltd.com
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DPT
DPT Laboratories is a contract development and manufacturing organization (CDMO) specializing in semi-solid and liquid dosage forms. For over 65 years, DPT has provided pharmaceutical, biotechnology, and healthcare companies the best solutions to their development and manufacturing needs. From concept to commercialization, DPT is the source for semi-solid and liquids.
318 McCullough
San Antonio, TX 78215
Phone: (210) 476-8159
Phone: (866) CALL-DPT (225-5378)
Fax: (210) 829-8733
Web: www.dptlabs.com
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DSM Nutritional Products Branch Pentapharm
Pentapharm is specialized in the development and manufacture of selective ranges of active ingredients for the pharmaceutical industry focusing on the therapeutical fields of anticoagulants, antifibrinolytics and haemostatics. Furthermore, using its expertise and experience in drug manufacturing, Pentapharm offers to the biopharmaceutical industry highest quality in manufacturing in conformity with cGMP as well as a full range of services to ensure full customer satisfaction and optimal regulatory compliance. Pentapharm covers production quantities up to multi kilograms and has large-scale chromatography and lyophilization capacities
Engelgasse 109
CH - 4002 Basel
Phone: +41 61 319 96 96
Fax: +41 61 319 96 19
Email: services@pentapharm.com
Web: www.pentapharm.com
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DSM Pharmaceutical Products
DSM Pharmaceutical Products is a global provider to the pharmaceutical and biopharmaceutical industries. With contract manufacturing services including: advanced intermediates, active ingredients (API’s), amino acids and derivatives, mammalian cell culture production (fed-batch and perfusion) of monoclonal antibodies, proteins, vaccines, finished dose manufacturing of solid dose, scheduled drugs, liquids, aseptic liquid and lyophilized products. From clinical to commercial services, DSM provides the highest level of service and quality while applying innovative solutions to satisfy customers’ unique manufacturing needs.
45 Waterview Blvd.
Parsippany, NJ 07054
Phone: (973) 257-8011
Email: info.dsmpharmaceuticals@dsm.com
Web: www.dsmpharmaceuticals.com
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Enzon Pharmaceuticals
Enzon Pharmaceuticals provides manufacturing, formulation, fill and finish of parenteral products at its Indianapolis facility. Specializing in complex formulations including liposomal products, Enzon offers complete manufacturing services from formulation to final packaging. High-speed vial filling and packaging lines are complemented by dual chamber vial filling and packaging capabilities. Our staff has an average of 20 years experience in manufacturing complex sterile formulations. From clinical to commercial products we provide the services you require. For more information contact: Tom Puskar, Business Development.
685 Route 202/206
Bridgewater, NJ 08807
Phone: 908-541-8758
Fax: 908-575-9169
Web: www.enzon.com
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Gibraltar Laboratories
Gibraltar Laboratories' scientific standing and expertise make the company the most valuable resource-as both consultants and advocates-that a client can have in navigating the regulatory approval process. In case after case, GBL's work has earned the respect of both peers and policy-makers. Gibraltar also maintains key affiliations with professional bodies that help set the standards which may affect GBL's clients-ISO, USP, AAMI, ASM, etc. Through these affiliations, GBL is able to keep clients apprised of pending regulatory issues as well as the latest trends in industry.
122 Fairfield Rd.
Fairfield, NJ 07004-2405
Phone: (973) 227-6882
Fax: (973) 227-0812
Web: www.gibraltarlabsinc.com
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Glatt Pharmaceutical Services
Glatt Pharmaceutical Services, a global leader in modified release technology, announces the inauguration of its new solid dosage facility in Ramsey, NJ. Our expanded capacity concentrates on complex controlled release R&D and manufacturing, including organic solvent coating capacity, our proprietary CPS™ pellet system, fluid bed and high shear granulation, and Glatt’s unsurpassed Wurster HS technology. Product 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™, a proprietary drug delivery technology, Cellets™, MCC Core Spheres.
20 Spear Rd.
Ramsey, NJ 07446
Phone: (201) 825-8700
Fax: (201) 825-0389
Web: www.glattpharmaceuticals.com
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Greiner Bio-One GmbH
Greiner Bio-One GmbH based in Frickenhausen Germany – the BioScience division of Greiner Bio-One International (Kremsmunster, Austria) – has emerged as a leading technology partner to academia, diagnostic, pharmaceutical and biotechnology industries on a global basis. The BioScience product range provides innovative solutions for research applications such as High-Throughput Screening of therapeutic agents in the pharmaceutical industry as well as protein coated cell culture products and the development of DNA-Chip technologies for diagnostics.
Maybachstrasse 2
72636 Frickenhausen
Phone: 07022-948-0
Fax: 07022-948-514
Email: info@de.gbo.com
Web: www.greinerbioone.com
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HollisterStier
HollisterStier is a customer-centric group of professionals dedicated to the contract manufacture of high quality sterile injectables for the global pharmaceutical and biopharmaceutical market. Our multidisciplinary teams provide custom solutions to customer specific project goals from development through commercialization. Based in Spokane, Washington, the company is committed to meeting customer expectations in all aspects of our business from quality manufacturing to regulatory support.
3525 North Regal St.
Spokane, WA 99207
Phone: (888) 844-6557
Fax: (509) 484-4320
Email: contract_manufacturing@hollister-stier.com
Web: fill.hollisterstier.com
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Hospira One 2 One
Hospira is a global specialty pharmaceutical and medication delivery company. The One 2 One® business unit is a world leader in the custom manufacture of parenteral products packaged in vials, flexible containers, cartridges, pre-filled syringes, and ampoules. With over 70 years of parenteral manufacturing experience, One 2 One® has been a reliable outsourcing partner to both large and small pharmaceutical companies. Working with One 2 One® gives you the peace of mind knowing that you have selected a contract manufacturer that is focused on customer service and security of supply.
275 North Field Dr.
Lake Forest, IL 60045
Phone: 224-212-2267
Fax: 224-212-3210
Email: One2One@hospira.com
Web: www.hospira.com
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Hyaluron Contract Manufacturing
HCM is a leading sterile contract manufacturer, aseptically filling syringes, vials, custom containers from pre-clinical to commercial scale, including Lyophiliza-tion. HCM may provide up to 150K syringes/day, 75K vials/day under cGMP compliance. HCM is ISO certified and inspected for drug and medical device by the FDA. HCM also offers patented Bubble-free filling™ of pre-filled syringes.
99 South Bedford Street
Burlington, MA 01803
Phone: (781) 270-7900
Fax: (781) 270-7899
Email: info@hyaluron.com
Web: www.hyaluron.com
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IPS
IPS is a recognized leader specializing in the delivery of technically complex, compliance-driven projects assisting our clients with the success of their capital programs. Our core services are centered on the engineering, design, construction, validation and commissioning of regulated facilities. Our turn-key capabilities led by our Subject Matter Experts encapsulate pharmaceutical facility and process equipment engineering, design/build, construction management, environmental, compliance and commissioning services. IPS provides Affordable Innovation formulating solutions that meet your criteria and your bottom line.
2001 Joshua Road
Lafayette Hill, PA 19444
Phone: 610-828-4090
Fax: 610-828-3656
Email: info@ipsdb.com
Web: www.ipsdb.com
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Kendle
Kendle International Inc. (Nasdaq: KNDL) is among the world’s leading global clinical research organizations and has been named “Best CRO” for the second year running by Scrip World Pharmaceutical News. We deliver innovative and robust clinical development solutions — from first-in-human studies through market launch and surveillance — to help the world’s biopharmaceutical companies maximize product life cycles and grow market share.
441 Vine Street, Suite 1200
Cincinnati, OH 45202
Phone: (800) 733-1572
Phone: 513-381-5550
Fax: 513-381-5870
Email: moehring.doug@kendle.com
Web: www.kendle.com
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Lancaster Laboratories
Lancaster Laboratories, one of the nation’s leading testing laboratories, offers comprehensive chemical and microbiological analytical resources to pharmaceutical and biopharmaceutical clients worldwide. Further expanding global services, Lancaster Laboratories has acquired Microchem Laboratories in Ireland, a premier research and testing lab. Since 1961, Lancaster Laboratories has provided a broad scope of services, technical expertise and stellar regulatory compliance for an outstanding service experience for clients worldwide.
PO Box 12425
Lancaster, PA 17605-2425
Phone: (717) 656-2300
Fax: (717) 656-3772
Web: www.lancasterlabs.com
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Laureate Pharma
Laureate Pharma, a full service biopharmaceutical development and protein production company, located in Princeton, NJ offers superior bioprocessing services that accelerate new products from development through production. Our wide range of specialized services include process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services and regulatory support. We focus on two active segments of the biopharmaceutical industry: monoclonal antibodies and recombinant protein products. Laureate Pharma, Inc. is a fully owned subsidiary of Safeguard Scientifics, Inc. (NYSE: SFE).
201 College Rd. East
Princeton, NJ 08540
Phone: (609) 919-3400
Fax: (609) 520-3963
Email: info@laureatepharma.com
Web: www.laureatepharma.com
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Lonza
For over 25 years Lonza has helped emerging and large biotech and pharmaceutical companies improve and advance their products with a full set of process development services and cGMP manufacturing, whether for preclinical or commercial supply. Our industry-leading manufacturing processes and advanced technology platforms enable products to reach their full potential. Services include: Monoclonal antibodies; Antibody fragments; Recombinant proteins; Cell therapy; Microbial fermentation; Vaccines; Plasmid DNA; Peptides; Oligonucleotides; APIs & HAPIs; Advanced intermediates; Chemical synthesis; Biotransformation; Antibody drug conjugates.
Muenchensteinerstr. 38
CH-4002 Basel
Phone: +41 61 316 8111
Email: contact@lonza.com
Web: www.lonza.com
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Metrics
Metrics, Inc. is one of the fastest-growing contract pharmaceutical development laboratories in the United States. The company provides quality formulation, clinical trial material manufacturing and analytical development/validation services to the pharmaceutical industry. Recently, Metrics announced a $17.5-million facility expansion. The 47,000 sf. facility will allow the company to hire over 50 new employees and dramatically supplement its clinical batch manufacturing. The new facility will also allow Metrics to expand its commercial production capabilities. For more information about Metrics and its services, visit www.metricsinc.com.
1240 Sugg Parkway
Greenville, NC 27834
Phone: 252-752-3800
Fax: 252-758-8522
Email: marketing@metricsinc.com
Web: www.metricsinc.com
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Norwich Pharmaceuticals
Norwich is 100% dedicated to pharmaceutical outsourcing, providing manufacturing, packaging, and associated QA/QC services. Capabilities include tablets and capsules, solids & liquids in capsules, and liquid /semi-solid manufacturing & packaging.We have dry granulation, fluid bed, and high shear granulation capabilities. We recently added two Bosch 1500 encapsulators, bringing our encapsulator total to five. We have a Clinical Suite, several Intermediate Potency Areas and are licensed for Controlled Substances. Quality services include analytical, micro, stability, and validation. We have an excellent record with the FDA and MHRA.
6826 State Highway 12
Norwich, NY 13815
Phone: (607) 335-3000
Fax: (607) 335-3100
Email: info@norwichpharma.com
Web: www.norwichpharma.com
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Patheon
Patheon is a leading global provider of integrated drug development and contract manufacturing services. Patheon operates a network of 14 facilities in Europe and North America, employing more than 5,300 people and serving a client base of more than 250 pharmaceutical, biotechnology and specialty pharmaceutical companies. Patheon’s Quick to Clinic™ programs utilize a variety of tools and development strategies and are exclusively focused on accelerating early phase development and conserving the amount of active pharmaceutical ingredients (API) used.
7070 Mississauga Road, Suite 350
Mississauga, Ontario, Canada L5N 7J8
Phone: (888) PATHEON
Phone: (905) 821-4001
Email: patheon@patheon.com
Web: www.patheon.com
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PharmaZell
PharmaZell provides small molecule drug substance and drug product development and production services to industry innovators on a custom, proprietary basis. With agency-inspected, cGMP-compliant facilities in Germany, Denmark and India, PharmaZell offers a broad range of chemistry, process, commercial and registration capabilities to advance new drugs through clinic to market.
P.O. Box 41005
Brecksville, OH 44141
Phone: 908-904-1239
Fax: 908-904-1240
Email: del.alley@pharmazell.com
Web: www.pharmazell.com
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PPD
PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 31 countries and more than 10,400 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.
929 North Front Street
Wilmington, NC 28401
Phone: 910-251-0081
Fax: 910-762-5820
Web: www.ppdi.com
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Regis Technologies
Since 1956 Regis Technologies, Inc. has been a leader in the world of complex chemistry, providing organic synthesis services for governmental agencies and many public and private firms. Regis is an FDA inspected and fully GMP compliant facility, capable of taking your product from development through commercialization. In 2006, while celebrating its 50th anniversary, Regis Technologies is completing another multi-million dollar expansion to offer expanded GMP manufacturing capacity, more R&D space and a new SFC preparative separations unit. Contact: Sean F. Bradley, Director of Business Development.
8210 Austin Ave.
Morton Grove, IL 60053
Phone: 847-583-7631
Email: GMP@registech.com
Web: www.registech.com
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Ricerca Biosciences
Ricerca Biosciences is the only North American CRO to offer the unique IP-INDSM concept to pharmaceutical and biotechnology companies. The 40+ acre site encompasses all discovery and development services required to bring IP, in the form of a target or drug candidate, to a complete IND submission. The ability to perform both chemistry (medicinal chemistry, process chemistry, cGMP API kilo-lab and pilot plant production, complete analytical) and biology (DMPK, ADME, full toxicology, safety pharmacology, animal efficacy models, bioanalytical) as well as report writing and regulatory services at one site makes Ricerca the provider of choice for virtual, small, and medium-sized pharmaceutical companies seeking a successful IND submission.
7528 Auburn Road
Concord, OH 44077
Phone: 888-742-3722
Phone: 440-357-3300
Fax: 440-354-6276
Email: info@ricerca.com
Web: www.ricerca.com
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Sandoz
Sandoz is a fully integrated partner in development and cGMP production of recombinant peptides and proteins. In the field of microbial fermentation, Sandoz offers production capacity at 100L, 1,300L, 3,000L, 13,000L and 40,000L scale in a facility in Kundl/Austria. The flexibility of production capabilities and fully integrated services accompanied with a highly skilled and customer-oriented team makes Sandoz an ideal partner for production cooperations.
Biochemiestrasse 10
A 6250 Kundl
Phone: +43 (0)5338 200 680
Fax: +43 (0)5338 200 442
Web: www.sandoz.com
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SGS Life Science Services
SGS Life Science Services is a leading contract service organization providing clinical research services and quality control testing. We serve a variety of Life Science companies including pharmaceutical, biopharmaceutical, biotechnology and medical device manufacturers. Our quality control testing services include analytical chemistry, microbiology, stability studies, method development & validation, toxicology tests and protein analysis. With 14 laboratories worldwide (including facilities in NJ, IL, and Canada), SGS represents the largest network of contract analytical laboratories.
75 Passaic Ave.
Fairfield, NJ 07004
Phone: (973) 244-2435
Fax: (973) 244-1823
Email: us.qualitycontrol@sgs.com
Web: www.sgs.com/lifescience
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Shimadzu Scientific Instruments
Shimadzu is a world leader in the manufacture of scientific equipment, offering a full line of analytical measurement and testing instrumentation for a broad range of applications in science and industry. Products include chromatographs (LC/HPLC/UFLC, GC); mass spectrometers (GC/MS, LC/MS, MALDI); life science instruments; spectrophotometers (FT-IR, Fluorescence, UV-VIS-NIR); atomic spectrometers (AA, ICP); X-ray spectrometers (EDX, XRD, XRF); thermal analyzers; Total Organic Carbon (TOC) analyzers; data systems/software; particle size analyzers; balances; and material testers.
7102 Riverwood Drive
Columbia, MD 21046
Phone: 800-477-1227
Fax: 410-381-1222
Email: webmaster@shimadzu.com
Web: www.ssi.shimadzu.com
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Southern Research
Southern Research provides industry-leading non-clinical contract research with particular expertise in cancer and infectious disease indications. Capabilities include: Efficacy Models – cancer; angiogenesis; and, infectious diseases. Nonclinical Toxicology – regulatory-compliant GLP studies (range-finding through carcinogenicity); ADME/PK; and, gene therapy/biologics. Bioanalytical Sciences – bioanalytical chemistry; quantitative and RT-PCR; in vitro lead optimization; proteomics; clinical pharmacokinetics; and, gene expression profiling and genotyping. Inquire about our PK Kwik program for expedited PK studies.
2000 9th Avenue South
Birmingham, AL 35205
Phone: 888-322-1166
Phone: 001-205-581-2830
Fax: 205-322-7473
Email: BusDev@SouthernResearch.org
Web: www.SouthernResearch.org
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Talecris Biotherapeutics
At Talecris Biotherapeutics, Inc., Melville, NY facility (formerly Precision Pharma Services) we offer contract manufacturing and testing services ranging from clinical, small-scale and commercial-stage products - specializing in sterile pharmaceutical, biopharmaceutical and complex biological finished products. You’ll find we’re a reliable outsourcing partner with an excellent record of regulatory compliance.
155 Duryea Rd.
Melville, NY 11747
Phone: (631) 845-6244
Fax: (631) 752-7354
Email: ncoles@precisionpharma.com
Web: www.talecris.com
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Toxikon
Toxikon Corporation is an ISO 17025-certified global Contract Research Organization (CRO) that conducts safety testing studies for biopharmaceutical and medical device industries. With 30 years of industry expertise, Toxikon provides FDA/ISO/ICH, USP and Japanese compliance testing services to meet the needs of the expanding healthcare and pharmaceutical industries. Services include a complete range of PK, TK, ADME and toxicology studies, as well as carcinogenicity, bioavailability, chemical characterization, impurities analysis and synthesis, bioanalytical and microbiology assays.
15 Wiggins Ave
Bedford, MA 01730
Phone: 800-458-4141
Fax: 781-271-1133
Web: www.toxikon.com/markets-pharmaceuticals.htm
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UPM Pharmaceuticals, Inc.
UPM Pharmaceuticals, Inc. is a Baltimore-based drug development and contract manufacturing company providing customized formulation development, manufacturing, and analytical services. Fully appreciating that flexibility and time-to-market are critical, UPM is highly responsive to clients’ drug program needs—from early-stage development to commercialization. UPM is characterized by the timeliness and thoroughness with which all projects are managed. Every step of the way, UPM Pharmaceuticals works to advance and optimize products through up-to-date resourceful approaches.
6200 Seaforth St.
Baltimore, MD 21224
Phone: 410-843-3738
Fax: 410-633-4438
Web: www.upm-inc.com
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Vetter Pharma-Fertigung GmbH & Co. KG
Vetter is an independent international specialist in the production of aseptically pre-filled injection systems, cartridges and vials. For more than 25 years Vetter has been renowned for its quality, innovation and strategic partnerships. The fact that our products and processes have been approved by the FDA, the EMEA and other authorities ensures the highest level of quality and safety. Vetter provides support for its pharmaceutical and biotech clients from the initial phases of development and regulatory approval process through to the successful product launch and market supply worldwide. Our innovative patented application systems will help your product to attain a decisive edge in the market.
Schuetzenstrasse 87,
88212 Ravensburg, Germany
Phone: +49-751-3700-0
Fax: +49-751-3700-4000
Email: info@vetter-pharma.com
Web: www.vetter-pharma.com
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Watson-Marlow Flexicon
Watson-Marlow Flexicon is a world leader in aseptic peristaltic filling, providing optimal solutions for to the pharmaceutical, biotech and diagnostic industries. Our focus is on small to medium size batch productions that require flexibility, high precision, and efficiency. We supply stand-alone table top units for hand filling, semi-automatic systems and fully automated fillers integrating our unique peristaltic technology. Our exclusive aseptic filling technology offers no risk of cross-contamination by utilizing a single-use fluid path.
156 College St.
Burlington, VT 05401
Phone: 802-657-3232
Fax: 802-657-3202
Web: www.flexiconamerica.com
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Wellspring Pharmaceutical
WellSpring provides clinical and commercial outsourcing services to the pharmaceutical industry that includes manufacturing and packaging of tablets, capsules, creams, lotions, ointments and liquids. We also offer clinical packaging and labeling services to meet our clients' most demanding clinical trial requirements. Since our operations adhere to strict FDA guidelines, our clients can be assured that the products we produce are of the highest quality and consistency.
400 Iroquois Shore Rd.
Oakville, Ontario L6H 1M5 Canada
Phone: (905) 337-4500
Phone: (866) 337-4500
Fax: (905) 337-7239
Email: salesinfo@wellspringpharm.ca
Web: www.wpcoutsourcing.com
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