Leading CMO, Aesica, has strengthened its links with the US market after its site at Queenborough (UK) passed its first FDA inspection for the production of solid dosage forms.
The success paves the way for the fast growing pharmaceutical manufacturer to transfer production of its US-based client’s solid dosage form product to the Aesica site in Queenborough, Kent. The FDA inspection officer made no specific observations. This audit follows a long history of successful inspections by the FDA for Active Pharmaceutical Ingredients (API) production.
Jeremy Drummond, Sales Director, Formulated Products, said: “This is a particularly significant development for Aesica and will help us gain credibility in the US market. At a time when Aesica is expanding its presence in North America, receiving this positive feedback from the FDA shows we are well positioned to satisfy the manufacturing needs of US-based pharma companies.”
The Aesica site in Queenborough has been FDA approved for the manufacture of APIs for over 20 years, and now offers US pharma companies peace of mind when sourcing either API or dosage forms from the Queenborough facility. The Queenborough site is already transferring in other solid dosage form products for the US market including one based on bi-layer tablet technology with which it has many years’ experience.
The successful audit of the Aesica site in Queenborough follows recent positive repeat audits by the FDA at Aesica’s European sites in Zwickau and Monheim, Germany and Cramlington, UK.