Granules India rises on USFDA nod for oral drug Glycopyrrolate

The ANDA has been filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company.

It is bioequivalent and therapeutically equivalent to the reference listed drug, Cuvposa Oral Solution of Merz Pharmaceuticals, LLC.

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients aged three to 16 years who have neurological conditions associated with problem drooling.

Krishna Prasad Chigurupati, chairman and managing director of Granules India said, 'As we strengthen Granules' footprint in the U.S. market, this approval highlights our robust quality systems, ensuring compliance with the highest regulatory standards.'

Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).

The pharma company reported a consolidated net profit of Rs 134.65 crore in Q1 FY25, steeply higher than Rs 47.89 crore posted in Q1 FY24. Revenue from operations in first quarter of FY25 was at Rs 1,179.87 crore, up 19.72% from Rs 985.52 crore reported in the same period a year ago.