USFDA gives warning letter to Aurobindo Pharma for API facility

It will be engaging with the regulator and is fully committed to resolving the issue at the earliest.

387
Warning Letter Sign FDA USFDA
Warning Letter

Last Updated on October 14, 2024 by The Health Master

Aurobindo Pharma yesterday said it has received a warning letter from the US health regulator for its Hyderabad-based Unit I, an Active Pharmaceutical Ingredient (API) manufacturing facility.

The action follows the recent inspection of the facility by the US Food and Drug Administration (USFDA) in August 2021, the drugmaker said in a regulatory filing.

“The company believes that this will not impact the existing business from this facility,” it noted.

The drugmaker stated that it will be engaging with the regulator and is fully committed to resolving the issue at the earliest.

The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, it noted.

Kerala DCA writes to NPPA to bring Kidney drug under DPCO

Pharma firms to install PNG run boilers to improve Air quality

Full marketing approval sought from DCGI for Covaxin

USFDA gives nod to Glenmark for Nasal Spray to treat allergic..

Narcotic Control Bureau seizes Drugs worth Rs 30 lakh

Big Pharma Companies buying land in Hyderabad

Govt warns against overuse, misuse of COVID medicines

BIS notifies new standard for these Medical Devices

Latest Notifications: Medical Devices

Latest Notifications regarding Pharmaceuticals

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