Biocon to address French regulator concerns in a quarter: Mazumdar Shaw

Firm to take remedial steps at its unit, get it inspected again in order to obtain GMP certification

Kiran Mazumdar Shaw, chairman and managing director of Biocon says that India's largest Biopharma company will take remedial measures at its drug product facility within a quarter and ask the French medical regulator to inspect its facility again to get certified for good manufacturing practice (GMP).

Biocon has filed for regulatory approvals to market its biosimilars =- Trastuzumab and Pegfilgrastim, in the highly regulated European market with the European Medicines Agency (EMA). French National Agency for Medicines and Health Products Safety or ANSM conducted the mandatory site inspections on behalf of EMA as part of its pre approval procedures.

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