Biocon completes pre-approval USFDA inspection with 0 observations

Biocon completes pre-approval USFDA inspection with 0 observations

by admin- Monday, January 20th, 2020 03:45:01 PM

Biocon US Food and Drug Administration (FDA) carried out a Pre-Approval Inspection (PAI) of the Oral Solid Dosage Manufacturing Facility of Biocon Pharma Ltd, a subsidiary of Biocon, which was brought on by using the submission of an Abbreviated New Drug Application (ANDA).

The inspection of the Bengaluru facility, which came about between January thirteen and January 17, 2020, concluded with 0 observations and no Form 483 became issued.

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