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Granules India announced that the US Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for glycopyrrolate oral solution 1mg/5mL 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, 1 mg/5 mL of Merz Pharmaceuticals, LLC.
Glycopyrrolate oral solution is an anticholinergic medication indicated for paediatric patients aged three to 16 years who have neurological conditions associated with problem drooling.
"As we strengthen Granules’ footprint in the US market, this approval highlights our robust quality systems, ensuring compliance with the highest regulatory standards," said Dr Krishna Prasad Chigurupati, chairman and managing director, Granules India Limited.
Granules India Limited, incorporated in 1991 is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and a commitment to operational excellence, quality, and customer service.
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