Aesica Announces FDA Approvals for Germany Facility

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Aesica announced that it received continuing approvals from FDA for its bulk manufacturing and packaging operations in Germany.


Aesica, which is a contract development and manufacturing organization, announced on Feb. 2, 2015 that it would continue to grow its manufacturing and packaging services of pharmaceutical products bound for the United States. This announcement comes after the company received FDA pre-approvals for its Germany facilities in Zwickau and Monheim.


The Zwickau site offers bulk manufacture of pharmaceutical tablets, capsules, and controlled release products, with more than 90 products from more than 40 APIs. The Monheim facility houses logistics and distribution centers, with packaging for 1100 SKUs with multiple indications for all geographic markets. In addition to FDA approvals, the sites have also attained successful inspections from ANVISA (for the Brazilian market) and from the German Health Agency.

Source: Aesica