Granules Receives USFDA Nod for Generic Glycopyrrolate Oral Solution

Granules India's subsidiary, Granules Pharmaceuticals Inc, has been granted approval by the US health regulator for a generic Glycopyrrolate oral solution meant for pediatric patients with neurological conditions linked to drooling. Granules India announced that the US Food and Drug Administration (USFDA) has approved their abbreviated new drug application (ANDA) for the 1mg/5mL Glycopyrrolate Oral Solution.

It was stated that it is bioequivalent and has the same therapeutic effects as Cuvposa Oral Solution, 1 mg/5 mL by Merz Pharmaceuticals, LLC.

The oral solution of Glycopyrrolate is a medication that inhibits the action of acetylcholine and is recommended for children between the ages of three and 16 with neurological disorders that cause excessive drooling, the statement noted.

Granules India Limited, headquartered in Hyderabad, is a multinational pharmaceutical manufacturing company from India. Granules produces a variety of off-patent medications, such as Paracetamol, Ibuprofen, Metformin, and Guaifenesin, in high volumes for clients in both regulated and other global markets. Granules India Limited is also involved in the contract research and manufacturing (CRAM) sector.

Granules India was established in 1984 under the name Triton Laboratories. Paracetamol API was manufactured by Triton at its Bonthapally facility located near Hyderabad. Researchers at Triton discovered a more effective method for manufacturing the Paracetamol active pharmaceutical ingredient, resulting in reduced capital and raw material needs.