The United States Food & Drugs Administration has granted an exception to Glenmark Pharma's Baddi facility for the supply of Atovaquone Oral Suspension USP 750mg / 5 to the US market.
Atovaquone is used in the treatment of Pneumocystis Pneumonia in adults and children aged 13 or older, who cannot tolerate other medicines. The drug is sold under the brand name Mepron.
Glenmark's Baddi unit has been granted an exception as the USFDA placed it under an import alert 66-40 in October last year. An import alert 66-40 is issued when the company is not operating in conformity with current Good Manufacturing Practices (GMP).
In simpler words, the company cannot send any products made out of this facility to the US.
The company also mentioned that the exception has been granted due to medical necessity and potential drug shortage expectations and that it may be reconsidered if the market conditions change.
Glenmark's Baddi unit has been under the regulatory lens for many years. Initially, the regulator issued a warning letter for the unit in October 2019. The USFDA issued seven observations for the unit in June last year. It plans on engaging with the US drug regulator to resolve the import alert at the earliest.
The US market contributes to nearly a quarter of Glenmark's overall revenue. It was given final approval to launch the Atovaquone Oral Suspension in November 2018.
Shares of Glenmark have opened 1.5 percent higher in early trading at Rs 404.70.
First Published: Jan 27, 2023 9:15 AM IST
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