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Biopharmaceutical firm Biocon on Thursday said it has received Certificate of ‘GMP Compliance’ from Europe for its insulin manufacturing facility in Malaysia.
The facility was inspected by Irish drug regulator HPRA as the representative European inspection authority in April 2017.
“The certificate of GMP compliance reflects that the agency considered the site to be in compliance with the principles and guidelines of Good Manufacturing Practices for active substances, sterile drug products and quality control testing operations.
The Europe GMP compliance certificate helps Biocon insulin, particularly insulin glargine to gain entry into the highly regulated Europe market.
Biocon’s application to market insulin glargine is under review of Europe drug regulatory European Medicines Agency (EMA). Biocon’s insulin facility in Malaysia is one of Asia’s largest state-of-the-art integrated manufacturing facilities, set up with an investment of about USD 275 million, at the BioXcell Biotech Park in Johor, Malaysia.
The facility that employs over 600 professionals is designed to manufacture recombinant human insulin and insulin analogs to cater to the needs of people with diabetes in global markets.
The announcement came after market hours.
Shares of Biocon gained 0.48 percent to close at Rs 335.15 on BSE, the benchmark Sensex ended flat at 31,662.74 points.
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