Granules India Ltd rose for a third straight session today. The stock is quoting at Rs 686.45, up 1.63% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.12% on the day, quoting at 24728.5. The Sensex is at 80764.15, down 0.05%. Granules India Ltd has added around 32.57% in last one month. Meanwhile, Nifty Pharma index of which Granules India Ltd is a constituent, has added around 9.29% in last one month and is currently quoting at 22374.25, up 0.83% on the day. The volume in the stock stood at 8.52 lakh shares today, compared to the daily average of 26.57 lakh shares in last one month. The benchmark August futures contract for the stock is quoting at Rs 688, up 1.63% on the day. Granules India Ltd is up 132.26% in last one year as compared to a 27.49% gain in NIFTY and a 47.43% gain in the Nifty Pharma index.The PE of the stock is 36.39 based on TTM earnings ending June 24.Powered by Capital Market - Live

Granules India announced today that the U.S. 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 pediatric patients aged three to 16 years who have neurological conditions associated with problem drooling.Powered by Capital Market - Live

The ANDA has been 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 of Merz Pharmaceuticals, LLC. Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients aged three to 16 years who have neurological conditions associated with problem drooling. Krishna Prasad Chigurupati, chairman and managing director of Granules India said, 'As we strengthen Granules' footprint in the U.S. market, this approval highlights our robust quality systems, ensuring compliance with the highest regulatory standards.' Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs). The pharma company reported a consolidated net profit of Rs 134.65 crore in Q1 FY25, steeply higher than Rs 47.89 crore posted in Q1 FY24. Revenue from operations in first quarter of FY25 was at Rs 1,179.87 crore, up 19.72% from Rs 985.52 crore reported in the same period a year ago. Powered by Capital Market - Live

It is bioequivalent and therapeutically equivalent to the reference listed drug Desyrel Tablets of Pragma Pharmaceuticals, LLC. Trazodone tablets are indicated for the treatment of major depressive disorder in adults. The current annual U.S. market for Trazodone tablets is approximately $128 Million, according to MAT Jun 2024, IQVIA/IMS Health. Dr. Krishna Prasad Chigurupati, chairman and managing director, Granules India, said: 'We have received the approval within 10 months of filing the application, which is a testament to our strong R&D capabilities. The product will be launched within this quarter and the market share will grow steadily over the next few quarters.' Granules now has 65 ANDA approvals from the US FDA (64 final approvals and 1 tentative approval). Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs). The pharma company reported a consolidated net profit of Rs 134.65 crore in Q1 FY25, steeply higher than Rs 47.89 crore posted in Q1 FY24. Revenue from operations in first quarter of FY25 was at Rs 1,179.87 crore, up 19.72% from Rs 985.52 crore reported in the same period a year ago. The scrip rose 0.90% to currently trade at Rs 658.30 on the BSE. Powered by Capital Market - Live

Granules India announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, and 300 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug, Desyrel Tablets, 50 mg, 100 mg, 150 mg, and 300 mg, of Pragma Pharmaceuticals, LLC. Trazodone tablets are indicated for the treatment of major depressive disorder in adults. Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Limited said, 'We have received the approval within 10 months of filing the application, which is a testament to our strong R&D capabilities. The product will be launched within this quarter and the market share will grow steadily over the next few quarters.'Powered by Capital Market - Live