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Here is a list of GMP Bulk Active Manufacturers.
- The companies I have listed are capable of multistep small
molecule cGMP synthesis. As is the case with contract drug manufacturers,
cost, quality, and level of GMP compliance varies greatly. Due to the many details
concerning the characteristics properties of the reactions, the intermediates of the final compound, successful project management of outsourced synthesis projects requires, in my opinion,
the direct involvement of the chemist who developed the process internally.
Many times it is prefererable for the chemist to attend the synthesis
as many details are not often captured into the batch record.
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Contract GMP Synthesis
Bulk Active Manufacturers
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- Davos Chemical
- A global resource for custom chemistry and process
- development
- Exclusive Chemistry Ltd
- a research and development company specializing
- in custom synthesis of organic compounds and projects involving contract researches
- Carbogen Laboratories AG
- CarboGen Laboratories AG is specialized in the manufacture of
- experimental active pharmaceutical ingredients under cGMP protocol.
- Austin Chemical Company
- Austin Chemical Company, Inc. is a privately owned
- sales/marketing firm representing fine chemical manufacturers
- ProCyte Corporation
- GMP synthesis and other contract pharmaceutical
- development
- Hovione SA - Fine Chemicals for Healthcare
- Synthesis of Active Pharmaceutical Ingredients (API) for
- the pharmaceutical industry
- Regis Technologies
- Regis Technologies, Inc. has served as a partner in the development, scale-up, and manufacture of complex, multi-step custom synthetic products for clients in the pharmaceutical, diagnostic, and biotech industries
- Cedarburg Laboratories, Inc.
- Cedarburg Laboratories, Inc.’s mission is to satisfy the needs of our customers by providing laboratory to pilot scale custom manufacturing of active pharmaceutical ingredients and pharmaceutical intermediates according to cGMP guidelines
- High Force Research
- HFR specialise in chemical synthesis and R&D for the pharmaceutical, biotech and fine chemicals industries
- Dalton Chemical laboratories
- Dalton has capabilities in GMP synthesis to support the pharmaceutical and biopharmaceutical industry. Peptides, Oligos and small molecules are manufactured in our new state-of-the-art cGMP facility.
- C6 Solutions Ltd
- an independent chemical manufacturing company.
We specialise in organic chemistry and offer contract manufacturing services and a range of fine chemical intermediates to the crop science, health & nutrition and speciality markets.
- TCI America
- Contract GMP Synthesis
- Ortec, Inc.
- Ortec, Inc. is a unique chemical producer offering custom manufacturing services
- Albany Molecular Research
- Albany Molecular Research can assist with the synthesis of intermediates and active pharmaceutical ingredients according to GMP requirements.
- Optima Chemical Group LLC
- Optima Chemical Group is a custom contract/toll manufacturer of specialty organic chemicals
- Phoenix Chemicals Limited
- Phoenix Chemicals is dedicated to the safe handling of hazardous reactions by focusing on novel and innovative routes of chemical synthesis
- Aldrich Bulk Chemical
- Contract GMP Synthesis
- Ferro Pfanstiehl Laboratories
- Ferro Pfanstiehl Laboratories, Inc. specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin Injectable Formulation Ingredients, Pharmaceutical Intermediates and Active Pharmaceutical Ingredients, in gram to multi-ton commercial quantities.
- Industrial Research Limited
- Industrial Research Limited is New Zealand's largest provider of contract industrial process development research.
Copyright (C) 2006 by Christopher M. Marrs.
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