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AMINO GmbH Receives Permit to Produce
Amino Acids From Fermentation

Frellstedt (April 23, 2007) – Following a comprehensive audit and inpection, AMINO GmbH has been granted a production permit according to §13 paragraph 1 of the German Drug Act by the regulatory authorities of Brunswick and Oldenburg. With the implementation of the 14th amendment of the German Drug Act, manufacturers of active pharmaceutical ingredients (APIs) of microbial origin need a production permit issued by responsible authorities. AMINO GmbH produces amino acids from fermentation, which are considered APIs of microbial origin.

In addition, AMINO received a GMP certificate according to §64 paragraph 3 of the German Drug Act for its Frellstedt production facility and for the amino acids and other active substances manufactured there. The GMP certificate confirms the company’s adherence to the European GMP guidelines and compliance with the German Drug Act and the new drug and active substance manufacture directive (AMWHV).

AMINO GmbH, headquartered in Frellstedt, Germany, is a fully integrated producer of specialty amino acids with natural biological origins. Restructured in November 2006, the company is dedicated to producing pharmaceutical-grade and infusion-grade amino acids under strict cGMP standards using the best extraction and purification technology (concentrating on vegetable raw materials) or state-of-the-art biotechnology/fermentation as appropriate.