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Drug manufacturer Granules has received approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL.
Granules India, in a release on the US FDA approval for its subsidiary Granules Pharmaceuticals Inc’s (GPI) ANDA, said the approved product will be bioequivalent and therapeutically equivalent to the reference listed drug Merz Pharmaceuticals LLC’s Qevposa Oral Solution 1 mg/5 mL.
Glycopyrrolate Oral Solution is an anticholinergic drug indicated for pediatric patients aged 3-16 years with neurological problems associated with drooling. Krishna Prasad Chigurupati, CMD, Granules India, said, “As we strengthen Granules’ footprint in the US market, this approval highlights our robust quality systems, ensuring compliance with the highest regulatory standards.”
Shares of Granules India closed 1.77% higher at ₹ 673.95 per share on BSE.
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