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Company Statement

Biocon's Drug product Facility Receives EIR with VAI status, Inspection Closed

Bengaluru, Karnataka, India, November 20, 2017:

Biocon confirms that the U.S. Food and Drug Administration (FDA) has issued an 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 Jun 2017. The FDA has classified the outcome of this inspection as VAI (“voluntary action indicated”) and the EIR states that the inspection is closed.

 

- Company Spokesperson

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