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Granules India
Drug firm Granules India on Monday said it has received approval from the US health regulator to market a generic medication for attention deficit hyperactivity disorder. Granules Pharmaceuticals Inc, a wholly-owned subsidiary of the company, has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine extended-release orally disintegrating tablets in multiple strengths, the company said in a statement. The company's product is the generic equivalent of Adzenys XR-ODT, it added. The product will be manufactured at Granules' US-based facility located in Chantilly, Virginia. The medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of around USD 172 million according to IQVIA (IMS Health). Currently, the market has only one approved generic and one authorised generic, positioning Granules favourably to expand access to this crit
The US health regulator has pulled up Granules India for failing to maintain buildings for drug storage and avoiding adequate procedures regarding cleaning and maintenance of equipment at its Telangana-based formulations plant. In a warning letter to the company's Chairman and Managing Director Krishna Prasad Chigurupati, the US Food and Drug Administration (USFDA) stated that the company failed to establish and follow adequate written procedures for maintaining equipment at the Medchal-Malkajgiri-based manufacturing facility. The USFDA inspected the facility from August 26 to September 6, 2024. "Our investigators observed significant contamination in multiple ducts of non-dedicated use in the preparation of finished drug products manufactured at your facility," the USFDA stated. While filters were installed to prevent contamination, inadequate cleaning and maintenance processes rendered them ineffective, it added. "Swab samples collected from the ducts by your firm during the ...
Drug firm Granules India on Friday said it has acquired Switzerland-based CDMO firm Senn Chemicals AG for CHF 20 million (around Rs 192 crore). Senn develops and manufactures, Peptides and Peptides-based applications for its global customers, providing contract research, development, and manufacturing (CDMO) services. The acquisition is expected to be completed in the first half of 2025, Granules India said in a statement. "By entering the rapidly growing peptide therapeutics segment and acquiring CDMO capabilities, we are expanding into next-generation therapeutics that align with our commitment to innovation and affordability," Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India, said. Senn's expertise in peptide synthesis, coupled with company's large-scale, cost-efficient manufacturing capabilities, positions Granules to deliver high-quality peptide-based solutions globally, he added. Rico Wiedenbruch, Chairman, Senn Chemicals AG, said "With Granules' ...
Drug firm Granules India on Friday said its consolidated profit after tax declined 6 per cent year on year to Rs 118 crore for the third quarter ended December 31, 2024. The company reported a profit after tax of Rs 126 crore in the October-December quarter of the last fiscal. Revenue from operations declined to Rs 1,138 crore in the third quarter as against Rs 1,156 crore in the year-ago period, the Hyderabad-based said in a regulatory filing. "We continue to sustain our profitable growth in the finished dosages segment, driven by our North America business. We are enhancing quality and compliance through systemic improvements across our operations, including Gagillapur," Granules India Chairman & Managing Director Krishna Prasad Chigurupati said. The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations. Subsequently, the production resumed in October in a staggered manner, it ...
Drug firm Granules India on Tuesday said its subsidiary has received approval from the US health regulator for a generic medication used to treat attention-deficit hyperactivity disorder. Granules Pharmaceuticals, Inc (GPI) has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, the drug firm said in a statement. The approved drug is available in multiple strengths; 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, it added. The company's product is the generic equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, the company said. The medication is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults. Lisdexamfetamine dimesylate chewable tablets are currently published on the FDA Drug Shortages List, emphasising ..