Granules India’s Glycopyrrolate Oral Solution Receives FDA Approval

Granules India announced that the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1 mg/5 mL, filed by Granules Pharmaceuticals, Inc. This approval confirms that the solution is bioequivalent and therapeutically equivalent to Cuvposa Oral Solution 1 mg/5 mL by Merz Pharmaceuticals, LLC. Glycopyrrolate Oral Solution treats problem drooling in pediatric patients aged three to 16 years with neurological conditions. The Chairman and Managing Director of Granules India Limited highlighted that this approval underscores its commitment to high regulatory standards and expanding its U.S. market presence.