The receipt of European Union Good Manufacturing Practice approval for its Malaysian facility is a big positive for Biocon, which produces biologics (drugs manufactured from living organisms/components) in chronic therapies such as diabetes, oncology, and immunology for global markets.
The approval indicates that the drug regulator, after its inspections in May 2019, believes that the manufacturing facility is in compliance with the guidelines of GMP for drug substances, drug products, and insulin delivery devices. This approval provides a huge fillip to the company’s existing capacity, besides allowing it to ramp up supplies to Europe (from this facility) where is has

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