Biocon Ltd. on Thursday received a compliance certificate from the Irish drug regulator for its manufacturing and research facility in Malaysia.
Biocon Sdn. Bhd., its Malaysian subsidiary, was issued a certificate of Good Manufacturing Practices Compliance, for its insulin manufacturing unit, said a stock exchange filing by Biocon. The facility has been inspected by the European Medicine Agency in April.
This is Biocon's first overseas biopharma manufacturing and research facility that was set up with an investment of $275 million and employs more than 600 professionals. It has been designed to manufacture human insulin for the treatment of diabetes.
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Biocon has been developing a fast-acting oral insulin drug for a rarer case of diabetes Type 1, whose causes and preventive measures are yet not known. It has also filed an application with Drug Controller General of India for running clinical trials for a drug catering the more common type 2 diabetes.
Insugen and Basalog are the already selling insulin brands of Biocon's Biologics division, that contributes nearly 19 percent to its total revenue.
Shares of Biocon had closed 0.5 percent higher, ahead of the announcement, while the country's benchmark BSE Sensex ended trade flat.
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