USFDA approves Atovaquone supply from Glenmark's Baddi unit as exception

The US Food and Drug Administration has given an exception to Glenmark Pharmaceuticals Ltd's Baddi facility to supply Atovaquone oral suspension USP 750 mg/5 to the US market owing to a shortage for the drug, the company said in an exchange filing today.

The pharmaceutical company's Baddi unit in Himachal Pradesh had been facing US regulatory scrutiny and was kept under the import alert list by the USFDA since October 2022.

The exception was granted for supply of the drug due to a medical necessity and potential drug shortage expectations, the company said.

The exception will be reconsidered if the market conditions change.

The company committed to maintaining the highest quality and compliant production standards at all of its locations across the world and will work with the government to resolve the import warning as soon as possible, it added.

Any product made and exported from a facility that is under import Alert 66-40 by the US drug authority will be promptly seized by US customs.

Import alert also causes a delay in the plant's approval of new products.

According to the US regulator's official website, Import Alert 66-40 is "detention without physical examination of medications from enterprises which have not followed drug good manufacturing procedures." After an examination in June, the regulator declared the Glenmark facility in Baddi to be in "Official Action Indicated" condition.

Shares of the company were down 1.3% at 393.45 rupees at 10:00 IST on NSE.