Granules India Ltd

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

The aforementioned inspection was conducted between 28 July 2025 and 01 August 2025. There was one observation during that inspection, and the GLS had submitted its response within the stipulated time. With this approval, the GLS facility is now deemed approved by the U.S. FDA, marking a major milestone for Granules India as it expands its finished dosage manufacturing capabilities. This is the first FDA approval for the GLS site. The company plans to launch the approved product in the U.S. market soon. The same product is already approved and manufactured at Granules' Gagillapur facility. The new approval will help strengthen market share and support business continuity through multi-site manufacturing. Dr. Krishna Prasad Chigurupati, chairman & managing director, Granules India, said: 'We plan on launching the product into the U.S. market soon. It is an already approved product at our Gagillapur facility, but we plan on building market share with this approval. We also have other products filed from this site and expect the U.S. FDA to approve them following necessary audits if required. This marks the first approval from our second Hyderabad facility with finished dosage capabilities. 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. The scrip fell 1.59% to currently trade at Rs 541.40 on the BSE. Powered by Capital Market - Live

Granules India today announced that its wholly owned subsidiary, Granules Life Sciences(GLS), located in Hyderabad (FEI: 3030495702), has received U.S. Food and Drug Administration (FDA) approval for a product that was the subject of a Pre Approval Inspection (PAI) conducted between 28 July and 01 August 2025. There was one observation during that inspection, and the GLS had submitted its response within the stipulated time.  With this approval, the GLS facility is now deemed approved by the U.S. FDA, marking a major milestone for Granules India as it expands its finished dosage manufacturing capabilities. This is the first FDA approval for the GLS site. The company plans to launch the approved product in the U.S. market soon. The same product is already approved and manufactured at Granules' Gagillapur facility. The new approval will help strengthen market share and support business continuity through multi-site manufacturing.Powered by Capital Market - Live

Granules India announced that the US FDA has issued an Establishment Inspection Report (EIR) to Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA, for the Pre-Approval Inspection (PAI) conducted by it in June 2025 for a first-to-file controlled substance ANDA. There was one observation during the inspection, and it has been resolved. Powered by Capital Market - Live

Granules India will hold a meeting of the Board of Directors of the Company on 13 November 2025.Powered by Capital Market - Live

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) following the FDA inspection conducted in June 2025. The company reported one observation during the inspection and confirmed that it had submitted its response within the stipulated timeframe. The company stated that this facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume. In addition to Paracetamol APIs, Granules India has also established Metformin and Guaifenesin API manufacturing plants at the same facility. The company remains committed to producing high-quality pharmaceutical products that meet global health standards. Dr Krishna Prasad Chigurupati, chairman & managing director, said, The successful completion of this US FDA inspection and the subsequent receipt of the EIR with a satisfactory VAI classification reflects our commitment to maintaining the highest quality standards in our manufacturing operations. 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 India Ltd rose for a third straight session today. The stock is quoting at Rs 474.65, up 1.1% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.49% on the day, quoting at 24591.5. The Sensex is at 80360.05, down 0.53%. Granules India Ltd has dropped around 3.22% in last one month. Meanwhile, Nifty Pharma index of which Granules India Ltd is a constituent, has dropped around 5.44% in last one month and is currently quoting at 21990, down 0.79% on the day. The volume in the stock stood at 26.06 lakh shares today, compared to the daily average of 14.2 lakh shares in last one month. The benchmark August futures contract for the stock is quoting at Rs 474.6, up 1.24% on the day. Granules India Ltd is down 32.56% in last one year as compared to a 2.23% fall in NIFTY and a 4.64% fall in the Nifty Pharma index.The PE of the stock is 40.27 based on TTM earnings ending June 25.Powered by Capital Market - Live