Granules India Gets USFDA Nod for Pediatric Glycopyrrolate Oral Solution

21 Aug 2024 , 03:13 PM

On August 20, Granules India announced that its subsidiary, Granules Pharmaceuticals Inc, has received approval from the US Food and Drug Administration (USFDA) for a generic version of Glycopyrrolate Oral Solution.

The approved product is an abbreviated new drug application (ANDA) for Glycopyrrolate Oral Solution with a strength of 1 mg/5 mL.

This generic solution is bioequivalent and therapeutically equivalent to the reference drug, Cuvposa Oral Solution, 1 mg/5 mL, manufactured by Merz Pharmaceuticals, LLC.

At the time of writing on August 21, 2024 at 3:07 pm, shares of Granules India is trading at ₹694 which is a 2.85% gain than the previous close. Granules India stock has gained a total of 132% in the last one year, and almost 68% since the beginning of the year.

Glycopyrrolate Oral Solution is an anticholinergic medication used to treat pediatric patients aged 3 to 16 years with neurological conditions that cause drooling.

Granules India, based in Hyderabad, is a multinational pharmaceutical manufacturer. The company produces various off-patent drugs, such as Paracetamol, Ibuprofen, Metformin, and Guaifenesin, for both regulated and international markets.

Additionally, Granules India operates in the contract research and manufacturing (CRAM) sector.