Aesica, the global contract development and manufacturing organisation (CDMO), provides a full service controlled drugs service, covering the production of Active Pharmaceutical Ingredients (APIs) and the manufacturing of drug products with advanced, well established capabilities in place to handle drug development right through to full scale commercial product supply.
The huge growth in demand for controlled or scheduled drugs has led to major manufacturing challenges from API scale up, clinical formulation and commercial controlled drug product manufacturing. As a consequence, Aesica has made significant investments in its controlled drug handling capabilities at all stages in the process. The company has acquired full regulatory authority to handle and manufacture Schedule 1 API substances and all Schedule 2-4 scheduled drugs.
As a direct consequence of the resources invested, Aesica provides full API development with scale up for clinical and commercial scale product requirements, formulation development, clinical trial supply, through to full finished dose manufacturing and packaging. Key features included in the company’s suite of capabilities and technology are secure cGMP pilot plant facilities with the capability to handle up to the 100kg scale of production and commercial scale facilities equipped with advanced large scale multipurpose processors.
Chris Gowland, Managing Director, API at Aesica commented: “Our comprehensive range of services and capabilities in the manufacturing of controlled or scheduled drugs, to meet the vast market demand for the production of such narcotics, clearly positions Aesica as one of the world’s leading international CDMOs in this specialist field. We look forward to building further on our ten year expertise and continuing to meet the ever increasing demand for our services as a result of the strategic investments that we have made to date.”