US FDA had conducted cGMP inspection in Biocon's Drug Substance manufacturing site at Bangalore in September 2018. And Biocon passed all points and clears inspection without form 483.
This is kind of big success itself by an Indian biopharmaceutical company, Biocon. The audit was lasted for 5 days and FDA observed no issues with cGMP set up in Biocon.
Biocon's Spokesperson said on this occassion,"this is to inform you that the U.S. FDA conducted a periodic cGMP inspection of our Drug Substance manufacturing site at Bangalore Campus from Sep 17 - 21, 2018. The weeklong audit concluded without any observations and no Form 483 was issued. The successful audit of this site reflects our strong commitment to cGMP compliance.”
One day before this announcement, Biocon in partnership with Mylan had received approval for Fulphila®, a biosimilar to Amgen’s Neulasta® (pegfilgrastim) by European Medicines Agency (EMA).
