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Biopharmaceutical firm Biocon today said its Malaysian arm Biocon Sdn Bhd has received EU GMP compliance certificate from the Health Products Regulatory Authority of Ireland for its insulin manufacturing facility.
“Biocon’s subsidiary in Malaysia, Biocon Sdn Bhd, has been issued a certificate of ‘GMP compliance’ for its insulins manufacturing facility by HPRA (Ireland) as the representative European inspection authority,” Biocon spokesperson said in a statement.
The certificate reflects that the agency considered the plant to be in compliance with principles and guidelines of good manufacturing practices for active substances, sterile drug products and quality control testing operations, the statement added.
Biocon’s Malaysia facility was inspected by the European Medicines Agency (EMA) in April 2017.
“The facility is designed to manufacture recombinant human insulin and insulin analogs to cater to the needs of people with diabetes in global markets”, the statement said.
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