Biocon: USFDA concludes with zero observations

Biocon said that pre-approval inspection of the Bengaluru facility of its arm conducted by US health regulator was concluded with zero observations.

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NEW DELHI: Biocon said that pre-approval inspection of the Bengaluru facility of its arm conducted by US health regulator was concluded with zero observations.

The US Food and Drug Administration (USFDA) conducted a pre-approval inspection of the oral solid dosage manufacturing facility of Biocon Pharma, a subsidiary of Biocon, which was triggered by the submission of an abbreviated new drug application, the company said in a regulatory filing. 

“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 pharma company told stock exchanges. 

“We remain committed to global standards of quality and compliance,” the company spokesperson said. 

The shares of Biocon were trading at Rs 291.40 a piece in morning trade on BSE, up 0.33 per cent from their previous close.

Also read: Lupin gets 2 observations from USFDA

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