Biocon Gets Clean Chit From U.S. Drug Regulator For Bengaluru Unit
Biocon further expects U.S. FDA’s decision on Trastuzumab injection on Dec. 3.
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Biocon Ltd. today said its Bengaluru facility has been cleared by the U.S. drug regulator after an inspection.
The plant received an establishment inspection report from the U.S. Food and Drug Administration, with a voluntary action indicated status, the biopharmaceutical company said in an exchange filing.
The drug regulator had audited the pharmaceutical company’s aseptic drug facility between May 25 and June 3, it said.
“This is a positive inspection as it had raised a lot of concerns in the past. We had worked with the regulatory agency towards the closure,” the company’s Chairman and Managing Director Kiran Mazumdar-Shaw told BloombergQuint in an interview.
After Receiving EIR, the agency further indicated that we need to implement the CAPA (corrective action and preventive action) plan and resubmit the updated details. We are expecting U.S. FDA’s decision on Trastuzumab injection on Dec. 3.Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon
Trastuzumab is an antibody used to treat breast cancer.
“The FDA had classified the outcome as ‘voluntary action indicated’, and the letter from the regulator states that the inspection is closed,” the exchange filing said.
Besides, there is no pending inspections related to current Goods Manufacturing Practice with U.S. FDA at the moment, Shaw said.