Aesica Gains FDA Approval for German SitesBy
Aesica, a pharmaceutical contract development and manufacturing organisation (CDMO), a division of Consort Medical plc,has received continuing US Food and Drug Administration (FDA) approvals for both its bulk manufacturing and packaging operations in Germany.
The approvals follow the successful FDA pre-approval inspections of the Zwickau site, which bulk manufactures pharmaceutical tablets, capsules, and controlled release products, and the Monheim site, which houses logistics and distribution centers. In addition, both sites also secured successful inspections from ANVISA for the Brazilian market as well as from the German Health Agency.
The Zwickau site manufactures in excess of 90 products produced from over 40 different active pharmaceuticals ingredients and has on-site process development and quality-control laboratories. At the Monheim site, Aesica currently completes packaging for 1100 SKUs, produced with multiple indications for all geographic markets.