Glenmark Pharma Baddi facility drug gets import alert exemption by USFDA

The US Food and Drug Administration (USFDA) has provided an exception on supply of Atovaquone oral suspension to the US market due to medical necessity and potential drug shortage.

Earlier on 26 October 2022, the US drug regulator placed the Baddi, India facility under import alert 66-40 following the inspection conducted in June 2022.

Atovaquone is used to prevent or treat a serious lung infection called pneumocystis pneumonia (PCP). The drug maker said that the exception will be reconsidered if the market conditions change.

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

Glenmark Pharmaceuticals is primarily engaged in the business of development, manufacture and marketing of pharmaceutical products.

On consolidated basis, the company's net profit rose 1.1% to Rs 260.44 crore on 6% jump in net sales to Rs 3,312.49 crore in Q2 FY23 over Q2 FY22.

The scrip slipped 4.36% to currently trade at Rs 381.60 on the BSE.

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