Biocon in focus after EIR for Bengaluru facility

The USFDA approval to Pegfilgrastim was an indication that this facility will get cleared soon and EIR confirms that this facility is now in full compliance.

Jun 25, 2018 08:06 IST India Infoline News Service

Biocon Limited
Shares of Biocon will be in focus today after the firm has received Establishment Inspection Report (EIR) from the USFDA for its Bengaluru sterile drug product manufacturing facility. This plant had received USFDA form 483 observations in the inspection which occurred in April/May 2018.

This was a product pre-approval inspection by USFDA for Pegfilgrastim, which company has partnered with Mylan. This biosimilar is branded as Fulphila.

USFDA, on June 4, 2018 approved Biocon and Mylan’s Pegfilgrastim Biosimilar. This approval already was an indication that the site would get clearance soon. As per the EIR, inspection for this site stands closed.

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