Chemspec-API formed as joint venture of Shanghai Chemspec Corp. and API Inc., providing clients with a US manufacturer of APIs and pharmaceutical intermediates with access to extensive resources at Shanghai Chemspec.
Chemspec-API today announced its formation as a joint venture of Shanghai Chemspec Corp. and API Inc. The agreement between the two companies means that API Inc.’s Fairfield facility will operate as Chemspec-API, providing process research and development, cGMP production and CMC services. In addition to this, clients will now have seamless access to resources at Shanghai Chemspec with project management at Fairfield.
The joint venture is based on a collaboration that has been going on since 2010. “Access to Shanghai Chemspec facilities gives our clients significant advantages,” said Dean Wei, president, Chemspec-API. “We provide process R&D and CMC services through to cGMP production at our Fairfield facility. The joint venture allows seamless transfer of tasks to Shanghai Chemspec while project management remains at Fairfield. Clients are able to cut costs while production remains both reliable and scaleable. To date processes transferred have been cGMP steps formerly run at Fairfield but the door is open to client processes not previously run here.”
Chemspec-API’s Fairfield operation was founded in 1997 by Roche veterans as API Inc. Multiple FDA inspections have been completed and the firm moved to its current state of the art facility in 2010. Projects include development work on investigational drugs and production of a number of APIs.
Shanghai Chemspec Corporation is a leading China-based contract manufacturer of specialty and fine chemicals, particularly fluorinated chemicals, serving clients in various industries including electronics pharmaceuticals and agrochemicals. For the pharmaceutical industry, Chemspec is a reliable supplier of API starting materials for commercial drug production. Founded in 1996, the company’s headquarters and R&D center in Shanghai employs 100 chemists. Six manufacturing facilities situated in adjacent provinces provide a total reactor volume of 2 million liters and employ a further 1700. Facilities are operated under cGMP or ISO 9001:2008 standards.
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