USFDA provides exception to Glenmark's Baddi facility

USFDA provides exception to Glenmark's Baddi facility

By: IPP Bureau

Last updated : January 28, 2023 11:38 am



The company will engage with the agency to resolve the import alert at the earliest.


Glenmark Pharmaceuticals Limited has informed that due to medical necessity and potential drug shortage expectations, the USFDA has provided an exception to Baddi facility which enables the company to supply Atovaquone Oral Suspension USP 750 mg/5 to the US market. The exception will be reconsidered if the market conditions change.

The company will engage with the agency to resolve the import alert at the earliest. The company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe.

Glenmark USFDA

First Published : January 28, 2023 12:00 am