Aesica Receives Licence To Manufacture Controlled Substances

Aesica’s Cramlington, UK site has been recently granted a Home Office licence to allow manufacture and supply of substances listed in Schedule 2 of the Misuse of Drugs Act 1971.

Granting of this licence followed a programme of investment carried out to enhance the security of the site and its buildings, and the implementation of special procedures for handling of controlled substances.

These changes allow the Aesica Cramlington site to offer facilities for contract manufacture of controlled active pharmaceutical ingredients in quantities from a few kilogrammes in its GMP pilot plant to tonnes in one of its bulk API plants. The company said that the first contract-manufactured controlled drug for one of Aesica’s customers is already in production.

Aesica can now offer such controlled drug manufacturing capability at two sites in the UK: Queenborough and Cramlington covering both active ingredient synthesis and manufacture and packaging of finished dosage pharmaceutical forms.

Adam Sims, commercial director of Aesica, said: “This is a significant step forward for Aesica in terms of broadening our capabilities in line with our customers’ demand.”