Biopharmaceutical firm Biocon on Thursday said its insulin facility in Malaysia has been approved by the European Medicines Agency (EMA).
The EMA clearance facility will help the company secure its supply chain and expand sales of its insulin products in European Union countries. Currently, the EU market is served by Biocon's Bengaluru plant.
Biocon and Mylan’s biosimilar Insulin Glargine Semglee received regulatory approval from EMA in March 2018. It was launched in key European markets by Mylan in November 2018.
Biocon’s Malaysia facility is Asia’s largest integrated insulin facility, which 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 are currently marketed in Malaysia.
"(We) 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 Malaysia site was inspected in May 2019.
"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 company statement said.
The GMP compliance certification reflects that the agency (EMA) 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 added.
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