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European drug regulator approves Biocon's Malaysia insulin facility

Bengaluru , Aug 22 : Biopharmaceutical major Biocon said on Thursday said its insulin facility in Malaysia has been approved by the European Medicines Agency.

Biocon Sdn Bhd, which operates Asia's largest integrated insulin facility, has received the Certificate of Good Manufacturing Practices. The site was inspected in May.

"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 the European Union," the company said in a statement. Currently, the EU market is served by Biocon's Bengaluru plant.

Biocon's Malaysia facility manufactures drug substance and drug products in vials, cartridges and insulin delivery devices. "We received the certificate of GMP compliance from the European Medicines Agency from the representative European inspection authority, Health Products Regulatory Authority (Ireland)," the company said.

Biocon's biologics business started the current fiscal year 2019-20 with a robust revenue growth of 96 per cent at Rs 490 crore in the first quarter (April to June). "This business aims to impact 2.6 million patient lives in FY 20 and aspires to position the company as a global leader," the company said.

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European drug regulator approves Biocon's Malaysia insulin facility


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