Drugmaker Granules has received U.S. Food and Drug Administration (U.S. FDA) approval for its abbreviated new drug application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL.
The approved product will be bioequivalent and therapeutically equivalent to the reference listed drug Merz Pharmaceuticals LLC’s Cuvposa Oral Solution1 mg/5 mL, Granules India said in a release on the U.S. FDA nod for subsidiary Granules Pharmaceuticals Inc. (GPI) ANDA.
Glycopyrrolate Oral Solution is an anticholinergic medication indicated for paediatric patients aged 3-16 years who have neurological conditions associated with problem drooling. “As we strengthen Granules’ footprint in the U.S. market, this approval highlights our robust quality systems, ensuring compliance with the highest regulatory standards,” said Granules India CMD Krishna Prasad Chigurupati said.
Granules India shares closed 1.77% higher at ₹.673.95 each on the BSE.
Published - August 20, 2024 05:55 pm IST
