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

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 News

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 News

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

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 News