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

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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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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Mon, February 18 2019. 09:07 IST
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