A Malaysian Biocon facility has received a Certificate of GMP compliance from the EMA for insulin-related production. Indian Biocon operates Asia's largest integrated insulins facility.
This approval expands Biocon’s capacities multi-fold with the new large-scale devices facility coming up to speed to serve the growing needs of people with diabetes in EU.
The Malaysia site was inspected in May 2019 and the certificate of GMP compliance received now reflects that the agency considers the manufacturing facilities for drug substances, drug products and insulin delivery devices to be in compliance with the guidelines of Good Manufacturing Practices.
Biocon’s Malaysia facility manufactures drug substance and drug products in vials, cartridges and insulin delivery devices.
Specifically recombinant human insulin (rh-insulin) and insulin glargine are manufactured at this facility. Biocon and Mylan’s biosimilar insulin glargine Semglee has previously received regulatory approval from the EMA in March 2018 and has been launched in key European markets by its partner Mylan since November 2018.
Biocon is emerging as an insulin player globally, the company has over 15 years of experience in addressing the needs of patients with diabetes, having provided over 2 billion doses of insulins cumulatively, worldwide.
The range of insulins made the Malaysia facility are serving patient populations in EU and several other countries across the globe.
Biocon's rh-Insulin is registered in over 40 countries worldwide and has been commercialised in many emerging markets. The company’s biosimilar insulin glargine has been approved in over 60 countries and is commercialised in several key emerging markets.
