Aesica secures continuing FDA approval of its bulk manufacture and packaging sites in Germany
FDA inspection results means Aesica will continue to grow its manufacturing and packaging services for pharmaceutical products for the US market
Monheim, Germany, 2nd February 2015 – Aesica, the global pharmaceutical contract development and manufacturing organisation (CDMO), a division of Consort Medical plc, today announces 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."
Zwickau manufactures in excess of 90 products produced from over 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.
About Aesica:
- Aesica is a leading provider of finished dose and active pharmaceutical ingredient (API) development and manufacturing services to pharmaceutical partners.
- Aesica is a division of Consort Medical plc, a public company quoted on the premium list of the London Stock Exchange (LSE: CSRT).
- Consort Medical plc is a leading, global, single source drug and delivery device CDMO through its two operating subsidiaries Bespak and Aesica. Consort Medical is at the leading edge of innovation and is committed to investing in patient, clinician and customer driven innovation to create new treatments, new markets and new opportunities.
- The Consort medical Group has facilities in King's Lynn, Cambridge, Nelson, Milton Keynes, Cramilngton, Nottingham, Queenborough and Hemel Hempstead in the UK; in Monheim and Zwickau, Germany; in Pianezza, Italy.
For Aesica media enquiries, please contact Tristan Jervis or Alex Heeley at De Facto Communications on: +44 (0) 20 7203 6740/6745 or e-mail;[email protected]