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FDA Inspection Yields Insight Into Biocon/Mylan Biosimilars Manufacturing Challenges

Executive Summary

Biocon's Bangalore, India, biosimilars manufacturing operation needs quick fix to meet goal dates for pegfilgrastim and trastuzumab in US, even as it works to restore GMP compliance for EU marketing authorization.

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Will GMP Lapses Stall Biocon-Mylan’s Biosimilars Build-Up?

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