Aesica Pharmaceuticals, a global supplier of active pharmaceutical ingredients (APIs), finished dosage forms and custom synthesis solutions, has been licensed to manufacture controlled substances at its site at Cramlington in the UK.
The Home Office licence allows Aesica to manufacture and supply substances listed in Schedule 2 of the Misuse of Drugs Act 1971. Granting of the licence follows a programme of investment to enhance the security of the site and its buildings, and the implementation of special procedures for handling of controlled substances.
The site is now able to offer facilities for contract manufacture of controlled APIs in quantities from a few kg at its GMP pilot plant to tonnes at one of its bulk API plants. The first contract-manufactured controlled drug for one of Aesica's customers is already in production.
"This is a significant step forward for Aesica in terms of broadening our capabilities in line with our customers" demand," said Adam Sims, commercial director of Aesica.
Aesica can now offer controlled drug manufacturing at Queenborough and Cramlington in the UK, covering active ingredient synthesis and manufacture and packaging of finished dosage pharmaceutical forms.
