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 glargine manufactured at this facility are addressing the needs of over 350,000 diabetics in Malaysia. Biocon and Mylan's biosimilar insulin glargine, under the brand Semglee, had previously received regulatory approval from EMA in March 2018 and was launched in key European markets by its partner Mylan in November 2018.
Over a period of 15 years, Biocon has provided over 2 billion doses of insulin, cumulatively, worldwide. Its rh-Insulin is registered in over 40 countries, while its insulin glargine has been approved in over 60. Biocon's biologics business registered a revenue growth of 96 per cent at Rs 490 crore in the first quarter of FY20. This business aims to impact 2.6 million patient lives in FY20 and aspires to position the company as a global leader, said Biocon in a statement.