glenmark: USFDA gives exception to Glenmark Pharma to supply pneumonia drug from Baddi facility

Glenmark Pharmaceuticals Ltd on Friday said the US health regulator has provided an exception, enabling it to supply Atovaquone oral suspension to the US market from its Baddi facility, which has been under an import alert. In a regulatory filing, Glenmark said, “…due to medical necessity and potential drug shortage expectations, the USFDA has provided an exception, which enables the Company to supply Atovaquone Oral Suspension USP 750mg/5ml to the US market”.

The exception will be reconsidered if the market conditions change, it added.

Atovaquone oral suspension is indicated for the treatment of mild to moderate Pneumocystis pneumonia.

In October last year, Glenmark had stated that the US Food and Drug Administration has put its manufacturing plant at Baddi under import alert 66-40, with drugs produced at the unit can be detained without physical examination.

As per the USFDA, import alert 66-40 implies detention without physical examination of drugs from firms, which have not met drug GMPs.

The USFDA inspected the facility in June 2022 and subsequently placed it under “Official Action Indicated” status, implying that the regulator may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance with manufacturing norms laid down by it.

“The company will engage with the agency to resolve the import alert at the earliest,” Glenmark said in the filing.