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Biocon’s Glargine Facility Receives EU GMP Certification
Yesterday, Biocon announced it received EU GMP certification from EMA for its integrated insulin facility in Malaysia, which was inspected in May 2019. Biocon’s Malaysian facility manufactures insulin glargine and rh-insulin. Below, FENIX provides additional thoughts on the EU GMP certification in the context of the recent FDA 483 observations and impending Biocon/Mylan bs-glargine US launch.