Drugmaker Granules has acquired U.S. Meals and Drug Administration (U.S. FDA) approval for its abbreviated new drug utility (ANDA) for Glycopyrrolate Oral Answer 1mg/5mL.
The authorized product will probably be bioequivalent and therapeutically equal to the reference listed drug Merz Prescribed drugs LLC’s Cuvposa Oral Solution1 mg/5 mL, Granules India mentioned in a launch on the U.S. FDA nod for subsidiary Granules Prescribed drugs Inc. (GPI) ANDA.
Glycopyrrolate Oral Answer is an anticholinergic treatment indicated for paediatric sufferers aged 3-16 years who’ve neurological circumstances related to drawback drooling. “As we strengthen Granules’ footprint within the U.S. market, this approval highlights our strong high quality programs, guaranteeing compliance with the very best regulatory requirements,” mentioned Granules India CMD Krishna Prasad Chigurupati mentioned.
Granules India shares closed 1.77% larger at ₹.673.95 every on the BSE.
