Aesica, the global pharmaceutical contract development and manufacturing organization (CDMO), a division of Consort Medical, has announced it has received continuing FDA approvals for both its bulk manufacturing and packaging operations in Germany.
As a consequence, Aesica can continue to grow its manufacturing and packaging services for pharmaceutical products destined for distribution and export to the strategically important US market.
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 centres. In addition, both sites have also secured successful inspections from ANVISA for the Brazil market as well as from the German Health Agency.
Dr Werner Schick, Aesica’s General Manager, Germany, commented: “We are extremely pleased that the FDA continue to approve 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.”
“These approvals will allow Aesica to substantially grow its contract manufacturing and packaging services for supply of pharmaceutical products to the US market,” he added.
Zwickau manufactures in excess of 90 products produced from more than 40 different APIs and has on-site process development and QC laboratories. At Monheim, Aesica currently completes packaging for 1100 SKUs, produced with multiple indications for all geographic markets.