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.

496
USFDA Inspection audit
USFDA Inspection

Last Updated on December 31, 2023 by The Health Master

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

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news