Biocon Biologics gets USFDA EIR for Two Manufacturing Facilities
Bengaluru: Biocon Biologics India Ltd., a subsidiary of Biocon Ltd., said on Thursday it has received the Establishment Inspection Report (EIR) from the USFDA (the United States Food and Drug Administration) for the pre-approval inspection at two of its biologics manufacturing facilities in Bengaluru.
The inspection was conducted between September 10 and September 19, 2019, a company spokesperson said, adding, Biocon Biologics has responded to the regulator on the eight observations from this inspection, in October last year.
Subsequently, 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 spokesperson said. "The formal closure of the USFDA inspection is expected to enable filing of marketing authorisation applications for our biosimilar products in several global markets."
Biocon Limited is an innovation-led global biopharmaceuticals company committed to enhancing affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune.
It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe.