Biocon's Malaysian arm gets EU GMP certification for insulins manufacturing facility

Biotechnology major Biocon on Thursday said its Malaysian arm has received the European Union Good manufacturing practice (EU GMP) certification for its insulins facility in Malaysia.

Biocon Sdn Bhd, the company's subsidiary in Malaysia has received the Certificate of GMP compliance from the European Medicines Agency from the representative European inspection authority, Health Products Regulatory Authority (Ireland), Biocon said in a statement.

The integrated insulins facility in Malaysia manufactures drug substance and drug products in vials, cartridges, and insulin delivery devices was inspected in May 2019, it added.

"The recombinant human Insulin (rh-Insulin) and Insulin Glargine manufactured at this facility are addressing the needs of over 3,50,000 diabetic patients in Malaysia," Biocon said.

The company's range of insulins made at the facility is serving patient populations in the EU and several other countries across the globe, it added.

"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," the company said.

Shares of Biocon were trading at Rs 223.90 per scrip on BSE, up 0.27 per cent from the previous close.