Integrated Multi-Site Commercial Product Transfer

Utilising Almac’s UK & US commercial facilities, a global speciality healthcare company benefited from Almac’s expertise in integrated commercial product transfer for two of its branded generic products in the US market, completing technology transfer, CBE-30 approvals and finished pack commercial supply within a 10 month timeframe.

This case study illustrates how Almac overcame all logistical hurdles and technical hurdles including guaranteeing the API supply of a controlled substance from India and manufacturing two legacy products (tablets and capsules) with limited processing history, to provide an integrated commercial drug manufacture and packaging solution, to meet the needs of a key client.