Biocon said that its subsidiary Biocon Biologics India has received an Establishment Inspection Report from the USFDA for the the Pre-Approval Inspection (PAI) conducted at two of its biologics manufacturing facilities in Bengaluru.
Shares of Biocon were currently trading 1.68% higher at Rs 342.55.
In a announcement made before markets hours today, 16 April 2020, Biocon said that the inspection was conducted between September 10 and September 19, 2019.
Subsequent to the inspection, Biocon Biologics has received approvals for the two products Trastuzumab (Drug Product) and Pegfilgrastim (Drug Substance) from the U.S. FDA in 2019. The receipt of the Establishment Inspection Report (EIR) indicates a successful closure of the inspection.
Biocon's Spokesperson said that the formal closure of the U.S. FDA inspection is expected to enable filing of marketing authorization applications for biosimilar products in several global markets.
Biocon is an innovation-led global biopharmaceuticals company.
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