Aesica approval sets up further US expansion
pharmafile | April 16, 2012 | News story | Manufacturing and Production |Â Â Aesica, FDAÂ
UK contract manufacturer and ingredient supplier Aesica says its manufacturing facility at Queenborough has successfully passed its first FDA inspection for the production of solid oral dosage forms.
The green light will help the fast-growing company fulfil its strategy of growing its US presence, and comes after a string of successful audits of the Queenborough facility for active pharmaceutical ingredient (API) production.
Aesica said recently that the last 12 months have seen it achieve significant sales growth in the US, bolstered by increased demand for both commercial and development scale API services “from large pharma and emerging biotechnology companies across America”.
The company has made no secret of its intention to expand not only in APIs but also in the formulated products sector on the other side of the Atlantic, and said in February it intends to set up sites in North America for API production and formulation development.
The company has intimated that it may follow a similar path in the US as it has in Europe, combining organic growth with acquisitions to build market share.
Last year, the firm snapped up three manufacturing sites in Germany and Italy from UCB, a move which resulted in a doubling of its workforce, and it has said it plans to add manufacturing facilities to complement its sales offices on the east and west coasts of the US.
The latest approval will allow Aesica to transfer production of a US-based client’s solid dosage form product to Queenborough, which lies on the Kent coast.
Jeremy Drummond, Aesica’s sales director for formulated products, said: “This is a particularly significant development for Aesica and will help us gain credibility in the US market.”
The company set up its expansion in the US via an investment by private equity firm Silverfleet Capital towards the end of last year, which followed the departure of former backer LDC. At the time, Aesica said it also plans to expand into Asia during 2012.
Phil Taylor
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