Granules India gains over 2% after subsidiary gets USFDA nod for Glycopyrrolate Oral Solution

Granules India informed the exchanges in a filing that the US drug regulator has approved an Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL filed by its subsidiary Granules Pharmaceuticals Inc (GPI).

The company said in a release that Glycopyrrolate Oral Solution is an anticholinergic medication used to treat pediatric patients aged three to 16 who have neurological conditions associated with drooling.

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

Earlier on August 9, the company informed the exchanges that the USFDA approved its ANDA for Trazodone Hydrochloride Tablets USP, 50mg, 100mg, 150mg and 300mg.

Trazodone Hydrochloride Tablets are bioequivalent and therapeutically equivalent to the reference-listed drug, Desyrel Tablets, 50mg, 100mg, 150mg, and 300mg, which are made by Pragma Pharmaceuticals, LLC. The tablets are used for the treatment of major depressive disorder in adults.

The company said that the current annual US market for Trazodone tablets is nearly $128 million, according to IQVAI MAT June 2024 data.

The Chairman and Managing Director of Granules India Limited, Krishna Prasad Chigurupati said in the release that the Trazodone Hydrochloride Tablets will be launched within this quarter (Q2FY25).

Granules India Limited is a pharmaceutical company. The company is a manufacturer of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs).

Granules India shares closed at ₹675 apiece, up 1.72% on the NSE.