 "Biocon Biologics receives EIR from USFDA for two manufacturing facilities in Bengaluru")
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 10 September and 19 September, 2019, a company spokesperson said, adding, Biocon Biologics has responded to the regulator on the eight observations from this inspection, in October last year.
Click here to follow LIVE news and updates on stock markets
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.”
 "India and the problems with Chinese manufacturing overcapacity")
 "This Week in Explainers: Will recession in UK, Japan hit daily living?")
 "FirstUp: Nitish Kumar to seek trust vote, RLD to formally join NDA… The big stories today")
 "This Week in Explainers: What Uttarakhand’s Uniform Civil Code means for live-in couples")
 "India and the problems with Chinese manufacturing overcapacity")
 "This Week in Explainers: Will recession in UK, Japan hit daily living?")
 "FirstUp: Nitish Kumar to seek trust vote, RLD to formally join NDA… The big stories today")
 "This Week in Explainers: What Uttarakhand’s Uniform Civil Code means for live-in couples")