Granules India Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

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.

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Granules India will hold a meeting of the Board of Directors of the Company on 23 December 2025.

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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.

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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.

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