Granules India Ltd

Granules India will hold a meeting of the Board of Directors of the Company on 23 January 2026.Powered by Capital Market - Live

The company said the ANDA has been determined by the US Food and Drug Administration (USFDA) to be eligible for 180-day exclusivity. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of around $41 million. The exclusivity status strengthens Granules' position in developing and commercializing complex and differentiated generic products for the US market. Earlier, on 22 December 2025, Granules Pharmaceuticals received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets in multiple strengths, the generic equivalent of ADZENYS XR-ODT, also used for the treatment of ADHD. This product currently has only one approved generic and one authorized generic, with an addressable market of about $172 million. The company said the tentative approval for generic DYANAVEL XR tablets marks the second consecutive approval for Granules Pharmaceuticals within a few weeks, highlighting its growing capabilities in complex formulation development and regulatory execution. Dr. Krishna Prasad Chigurupati, chairman & managing director, Granules India, said, 'Having a product that is eligible for 180-day exclusivity, Granules strongly validates our long-term strategy of building a differentiated portfolio of complex generics. It also reinforces our commitment to strengthening our presence in the central nervous system (CNS) therapeutic space while enhancing value creation in the U.S. generics market.' Granules India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs). The company's consolidated net profit declined 16.3% to Rs 112.64 crore, while net sales increased 3.4% to Rs 1,208.79 crore in Q2 FY26 compared with Q2 FY25. Powered by Capital Market - Live

Granules Pharmaceuticals, Inc., a wholly owned subsidiary of Granules India, has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Amphetamine Extended-Release Tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, the generic equivalent of DYANAVEL XR'. The Granules ANDA has been determined to be eligible for 180-day exclusivity by the FDA, reinforcing its growing capabilities in developing and commercializing complex and differentiated generic products for the U.S. market. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of approximately USD 41 million. Granules previously received a tentative approval on December 22nd, 2025 for Amphetamine Extended Release Orally Disintegrating Tablets in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, the generic equivalent of ADZENYS XR-ODT' also for the treatment of ADHD. This product has only one approved generic and one authorized generic with an addressable market share of USD 172 million, positioning Granules favourably to expand access to this critical therapy upon launch. The tentative approval of generic gDYANAVEL XR tablets marks the second consecutive approval from Granules' subsidiary, Granules Pharmaceuticals, Inc., within a period of a few weeks. Powered by Capital Market - Live

Granules India announced that an Extra Ordinary General Meeting (EGM) of the Company will be held on 22 January 2026.Powered by Capital Market - Live

Granules India on 19 December 2025 said its wholly owned subsidiary, Granules Life Sciences, has completed a Good Manufacturing Practices and Prior Approval Inspection by the U.S. Food and Drug Administration. The inspection was conducted at the subsidiary's Hyderabad facility between 15 December and 19 December 2025. The regulator issued five observations, all related to procedural requirements. The company said none of the observations pertain to data integrity or product safety. Granules India added that it will respond to the observations within the stipulated timeframe. Granules Life Sciences is engaged in the manufacturing of pharmaceutical formulation intermediates and finished dosage forms. Granules India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs). The company's consolidated net profit declined 16.3% to Rs 112.64 crore, while net sales increased 3.4% to Rs 1,208.79 crore in Q2 FY26 compared with Q2 FY25. Shares of Granules India rose 0.50% to settle at Rs 583.30 on Friday, 19 December 2025. Powered by Capital Market - Live

Granules India will hold a meeting of the Board of Directors of the Company on 23 December 2025.Powered by Capital Market - Live

Granules India announced that its US step-down subsidiary, Granules Consumer Health, LLC, a wholly-owned subsidiary of Granules Pharmaceuticals, Inc., successfully completed a GMP inspection by the U.S. Food and Drug Administration (FDA) with zero observations. This was the facility's second FDA inspection, following the March 2023 audit that resulted in a No Action Indicated (NAI) classification. Granules Consumer Health plays a critical role in our global operations as a packaging and distribution site. We process controlled substances and over-the-counter (OTC) products across three advanced packaging lines. Achieving zero observations in this inspection reflects our unwavering focus on quality, safety, and regulatory excellence, said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India. Granules Consumer Health serves as Granules' front-end division for OTC products in the U.S., leveraging Granules India's manufacturing efficiencies, regulatory compliance, and integrated supply chain. Powered by Capital Market - Live

Granules India inaugurated two advanced Centres of Excellence at the Technology Research Park of IIT Hyderabad: the Ascelis Center of Excellence for Peptide Development and Characterization and the Granules Center of Excellence for Particle Engineering. Ascelis Center of Excellence for Peptide Development and Characterization, established under Ascelis Peptides, the CDMO arm of Granules, this Centre will drive the development of cosmetic, therapeutic, and pharmaceutical peptides. It is Ascelis' first development and characterization facility in India and is equipped for primary, secondary, and tertiary structure characterization. The Center brings advanced analytical and process development capabilities in-house and will work in collaboration with our Swiss-based R&D facility Senn Chemicals, strengthening the group's integrated global peptide offering and reducing reliance on external partners. Granules Center of Excellence for Particle Engineering, This Centre will advance polymorph research, material science, and novel drug delivery systems, including amorphous solid dispersions. It replaces earlier external and ad-hoc development with a dedicated research platform that enables first-to-file opportunities, enhances formulation performance, and supports the creation of proprietary technologies for regulated markets. Powered by Capital Market - Live

Net profit of Granules India rose 34.33% to Rs 130.61 crore in the quarter ended September 2025 as against Rs 97.23 crore during the previous quarter ended September 2024. Sales rose 35.35% to Rs 1294.67 crore in the quarter ended September 2025 as against Rs 956.52 crore during the previous quarter ended September 2024. ParticularsQuarter EndedSep. 2025Sep. 2024% Var. Sales1294.67956.52 35 OPM %21.4921.26 - PBDT247.89180.91 37 PBT175.87128.38 37 NP130.6197.23 34 Powered by Capital Market - Live

Net profit of Granules India rose 191.40% to Rs 120.61 crore in the quarter ended September 2025 as against Rs 41.39 crore during the previous quarter ended September 2024. Sales rose 57.26% to Rs 877.41 crore in the quarter ended September 2025 as against Rs 557.92 crore during the previous quarter ended September 2024. ParticularsQuarter EndedSep. 2025Sep. 2024% Var. Sales877.41557.92 57 OPM %24.0918.39 - PBDT202.6490.82 123 PBT161.9056.07 189 NP120.6141.39 191 Powered by Capital Market - Live