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Biocon Ltd Gets Clean Chit From US Drug Regulator

Biocon Ltd Gets Clean Chit From US Drug Regulator
Written by Shilpi Gupta

Biocon Bengaluru facility has been cleared by the U.S. drug regulator after an inspection, on Monday. The Biocon, biopharmaceutical company received an establishment inspection report from the U.S. Food and Drug Administration, with a voluntary action indicated status. The company spokesman said in a regulatory filing “Biocon confirms that the US food and drug administration (FDA) has issued as establishment Inspection Report (EIR) in relation to the cGMP( current Good Manufacturing Practice) inspection of its aseptic drug product facility that was audited between 25th May – 3rd June 2017.”

Earlier US FDA had issued a report in which they highlighted 10 observations on Biocon’s Bengaluru plant. This result is likely to have a positive impact on the stock of the company. Shares of Biocon surges on Monday morning after the company gets the clean chit from. “The FDA has classified the outcome of this inspection as “voluntary action indicated” (VAI) and the EIR states that the inspection is closed,” said the exchange filing. The US drug regulator had audited the Biocon Ltd, the pharmaceutical company’s aseptic drug facility between May 25 and June 3.

Kiran Mazumdar Shaw, Chairman, and Managing Director, Biocon, said, there are no pending inspections related to current Goods Manufacturing Practice with U.S. FDA at the moment.

About the author

Shilpi Gupta

Food Technologist by Profession and Blogger by Destiny. love to write articles on food technology, spirituality and social issues.

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