Biocon's Hyderabad Facility Receives Three U.S. FDA Observations
Biocon said it will be addressing the U.S. FDA observations within the stipulated time.
The U.S. Food and Drug Administration has made three observations for Biocon Ltd.'s Hyderabad facility.
"The U.S. FDA concluded a pre-approval inspection for Site 3, Biocon Ltd., located at Hyderabad, Telangana on July 20, 2022. Three observations were cited at the end of the inspection, which we will be addressing within the stipulated time," the company said in an exchange filing without disclosing the nature of observations.
The Hyderabad-based drugmaker assured that the company stands committed to the quality, safety and efficacy of its products.
Biocon has yet to respond to BQ Prime's emailed query.
Last month, the Securities and Exchange Board of India had issued a warning letter to Aurobindo Pharma Ltd. that the company had disclosed very limited and restricted information. The company did not disclose the reason and the non-compliance/aberration observed, for which the warning was issued.
Shares of Biocon were trading 0.24% lower on Friday compared with a 0.18% rise in the benchmark Sensex.