Biocon Ltd's Malaysian subsidiary has received the Certificate of Good Manufacturing Practice (cGMP) compliance from the European drug regulator for its integrated insulin facility, helping it expand capacity to serve the diabetes market in the European Union.
It has received the Certificate of GMP compliance from the European Medicines Agency from the representative European inspection authority, Health Products Regulatory Authority (Ireland), said the company.
The Malaysian facility was inspected in May 2019. It is Asia's largest integrated insulin facility and manufactures drug substances and drug products in vials, cartridges, and insulin delivery devices.
The recombinant human Insulin (rh-Insulin) and insulin