Biocon Ltd. has announced that it’s subsidiary in Malaysia, Biocon Sdn. Bhd., which operates Asia’s largest integrated insulin facility, received the Certificate of GMP compliance from the European Medicines Agency. The 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 to be in compliance with the guidelines of Good Manufacturing Practices.
Biocon’s Malaysia facility is Asia’s largest integrated insulin facility and manufactures drug substance and drug products in vials, cartridges and insulin delivery devices. The recombinant human Insulin (rh-Insulin) and insulin glargine manufactured at this facility address the needs of over 350,000 diabetic patients in Malaysia. Biocon and Mylan’s biosimilar insulin glargine, Semglee, previously received regulatory approval from EMA in March 2018 and launched in key European markets by Mylan since November 2018.
Biocon’s rh-Insulin is registered in over 40 countries and commercialised in many emerging markets. The company’s insulin glargine has been approved in over 60 countries and is commercialised in several key emerging markets.
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