UK based contract API maker Aesica Pharmaceuticals has been granted a Home Office license to make controlled substances at its facility in Cramlington, Northumberland.
The new license, which enables Aesica to manufacture and supply substances listed in Schedule 2 of the 1971 misuse of drugs act, follows a programme of investment and infrastructure development designed to improve and enhance security at the facility.
Commercial director, Adam Sims, described the award as a significant step forward for Aesica’s capabilities, adding that it will help the firm better respond to the demands of its drug industry clients.
Sims told Outsourcing-pharma that: "Over the last few years Aesica has seen an increase in the number of enquiries for manufacturing controlled drug substances.
"There are very few manufacturers offering such service in the UK mainly due to the restrictions imposed by the government and import / export regulations in various countries. It also requires an investment in order to enhance security and implement special procedures for handling controlled substances."
He added that the license allows Aesica to make anything from kilogrammes to tonnes of APIs and added that the firm has already started producing a controlled drug for one of its key pharmaceutical clients.
The Cramlington site is Aesica’s second to offer contract controlled substance API manufacture and packaging services for finished dosage forms after its facility in Queenborough, Kent.
Schedule 2 manufacturing
The manufacture of Schedule 2 drugs, which include diamorphine, pethidine as well as treatments for a number of behavioural conditions, is governed by strict rules requiring chain of custody monitoring and detailed production records.
As a result, only those contract manufacturing organizations (CMOs) with sufficient support and regulatory infrastructure to obtain the necessary permission and implement the required control procedure enter the market.
In addition to Aesica, other notable manufacturers include Novasep, SAFC Pharma and Cambrex as well as Indian firms Carbogen Amcis and Neuland, which have recently begun production of both controlled drugs and high-potency APIs.