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FDA Inspection Yields Insight Into Biocon/Mylan Biosimilars Manufacturing Challenges

 
• By Bowman Cox

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.

A US FDA preapproval inspection raises more questions about the readiness of the Biocon Ltd. biosimilars manufacturing facility in India that European authorities have found to be non-compliant with EU GMP requirements.

An FDA team issued a Form 483 report of inspectional observations made at the facility on April 7, just three weeks after France's inspectorate visited the site, which Biocon and...

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