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Business EconomyPosted at: Jan 20 2020 2:33PM


Biocon's oral solid dosage manufacturing facility completes pre-approval US FDA inspection

Mumbai, Jan 20 (UNI) Pharma Major Biocon Ltd on Monday said the US Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) of the Oral Solid Dosage Manufacturing Facility of Biocon Pharma Ltd, a subsidiary of the company, which was triggered by the submission of an Abbreviated New Drug Application (ANDA).
The inspection of the Bengaluru facility, which took place between January 13 and 17, 2020, concluded with zero observations and no Form 483 was issued, the company said in a filing with the BSE.
''We remain committed to global standards of Quality and Compliance," a company spokesperson said here.
UNI JS RJ 1428
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