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Company Statement

Biocon's Oral Solid Dosage Manufacturing Facility Completes Pre-Approval U.S. FDA lnspection with Zero Observations

Bengaluru, Karnataka, India, January 20, 2020

"This is to inform you that the U.S. 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 Biocon Ltd, 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.

We remain committed to global standards of Quality and Compliance."
- Company Spokesperson

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