Biocon has informed that the US Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) of the Oral Solid Dosage Manufacturing Facility of Biocon Pharma, 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 January 17, 2020, concluded with zero observations and no Form 483 was issued.
The above information is a part of company’s filings submitted to BSE.