Biocon intimates of two pre approval inspections of its facilities in Bengaluru

Biocon announced that the USFDA concluded two pre approval inspections of Biocon's manufacturing facilities in Bengaluru.

There were no observations and no Form 483 was issued after the pre-approval inspection of Biocon's Oral Solid Dosage Facility conducted between 11 February - 15 February 2019.

The pre-approval inspection of the company's additional, new injectable manufacturing line for a biologic drug product, conducted between 7 February - 15 February 2019, resulted in a Form 483 with two observations. Biocon intends to address these expeditiously.

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