BRIEF—Biocon Malaysia secures GMP certificate

The Malaysian business of India's largest biotech firm Biocon has received a Good Manufacturing Practice (GMP) compliance certificate from the European Medicines Agency (EMA).

The facility is Asia’s largest integrated insulins site and manufactures drug substance and drug products in vials, cartridges and insulin delivery devices.

Biocon and Mylan’s biosimilar insulin glargine Semglee was launched in Europe in late 2018. The therapy was  approved by the EMA in March of that year.