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Aesica Secures FDA Approvals at German Sites

Allows for expanded manufacturing and packaging services for U.S. market

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By: Kristin Brooks

Managing Editor, Contract Pharma

Aesica has received continuing FDA Approvals for its bulk manufacturing and packaging operations in Germany. The Zwickau site, which manufactures pharmaceutical tablets, capsules and controlled release products, and the Monheim site, which houses logistics and distribution centers, successfully completed pre-approval inspections. In addition, both sites had successful inspections from ANVISA for the Brazil market, as well as from the German Health Agency.

Dr. Werner Schick, Aesica’s general manager, Germany, said, “We are extremely pleased that the FDA approved our German sites for bulk manufacture and packaging. This is a testament to the quality of the technology, services and people at both of our German facilities. Theseapprovals will allow Aesica to substantially grow its contract manufacturing and packaging services for supply of pharmaceutical products to the U.S. market.”

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