Biocon's Bengaluru oral dosage facility completes pre-approval USFDA inspection

With zero observations

Biocon announced the successful conclusion of pre-approval inspection (PAI) conducted by USFDA at oral solid dosage manufacturing facility of Biocon Pharma, a subsidiary of the company. The inspection was triggered by the submission of an abbreviated new drug application.

The inspection of the Bengaluru facility, which took place between 13 - 17 January 2020 concluded with zero observations and no Form 483 was issued.

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