Glenmark Pharmaceuticals Ltd has informed that the U.S. FDA has issued Form 483 with one observation after an inspection at the Company’s formulation manufacturing facility based out of Aurangabad, India between June 27, 2022 and July 1, 2022.

As per the filing, the company is committed to undertake all necessary steps required to address their observation at the earliest.

The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.