Biologics India, a subsidiary of Biocon, has received the EIR from the US Food and Drug Administration (USFDA) for the Pre-Approval Inspection (PAI) at two of its biologics manufacturing facilities in Bengaluru,” the company said in an exchange filing.
The inspection was conducted between September 10 and September 19, 2019. Biocon
Biologics has responded to the regulator on the eight observations from this inspection, in the month of October 2019, it said.
The company further said that subsequent to the inspection, Biocon Biologics has received approvals for the two products Trastuzumab (Drug Product) and Pegfilgrastim (Drug Substance) from the USFDA in 2019. The receipt of the EIR indicates a successful closure of the inspection.
The formal closure of the U.S. FDA inspection is expected to enable filing of marketing authorization applications for our biosimilar products in several global markets, the company’s spokesperson said.
At 09:35 am, Biocon was trading 4 per cent higher at Rs 349 on the BSE, as compared to 0.74 per cent decline in the S&P BSE Sensex. A combined 2.3 million shares have changed hands on the counter on the NSE and BSE so far.