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- Granules India is digitizing manufacturing records and increasing facility oversight after the FDA flagged violations in good manufacturing practices at its largest plant in Telangana. - The company, one of the world's largest paracetamol manufacturers, failed to establish adequate equipment cleaning procedures and had torn data records found in plastic waste bags. - The drugmaker is implementing automation of data collection and increasing gemba walks across its 10 manufacturing facilities to prevent future regulatory issues. - While production continues, the FDA warning could temporarily affect approval of new products manufactured at the affected site.
- Granules Pharmaceuticals received tentative FDA approval for its generic amphetamine extended-release orally disintegrating tablets in six dosage strengths for ADHD treatment. - The product is a generic equivalent of ADZENYS XR-ODT with an estimated market size of approximately $172 million according to IQVIA. - Currently only one approved generic and one authorized generic exist in the market, positioning Granules favorably to expand access upon launch. - Manufacturing will take place at Granules' US facility in Chantilly, Virginia, strengthening the company's CNS therapeutic portfolio.
- Bengaluru-based longevity science startup Decode Age raised Rs 14.48 crore ($1.7 million) in pre-Series A funding led by Dr Krishna Prasad Chigurupati of Granules India. - The company has built one of India's most advanced whole genome gut microbiome analysis systems to provide insights into microbial diversity's influence on immunity, metabolism and ageing pathways. - Funding will expand biomarker discovery programmes, advance multi-omics research pipeline, and support development of research-driven supplements targeting age-related conditions. - Decode Age focuses on making aging biology measurable through precision-based interventions and microbiome-centered longevity solutions for healthy aging.
- Granules Life Sciences, a wholly owned subsidiary of Granules India, has secured its first US FDA approval for its Hyderabad manufacturing facility following a pre-approval inspection conducted in July-August 2025. - The FDA approval marks a significant milestone for Granules India as it expands its finished dosage manufacturing capabilities, with the company planning to launch the approved product in the US market soon. - The new approval will strengthen market share and support business continuity through multi-site manufacturing, as the same product is already approved and manufactured at Granules' Gagillapur facility. - Additional products have been filed from the Hyderabad site, with the company expecting further FDA approvals following necessary audits.
- Granules India is recalling over 33,000 bottles of Metoprolol Succinate extended-release tablets from the US market due to failed dissolution specifications during stability studies. - The US FDA classified this as a Class II recall, indicating potential for temporary or medically reversible health consequences with minimal likelihood of serious adverse outcomes. - This recall represents the latest in a series of quality control issues affecting Indian pharmaceutical manufacturers in the US market. - The affected medication failed to meet dissolution acceptance criteria at the sixth month of stability testing, prompting the nationwide recall initiated on June 24.
- The US Food and Drug Administration has issued a warning letter to Granules India citing serious contamination issues and inadequate maintenance at its Telangana formulations plant following an inspection conducted in August-September 2024. - Inspectors discovered significant contamination in multiple ducts, ineffective filtration systems, bird droppings within manufacturing areas, and numerous torn CGMP records containing critical manufacturing and testing data. - The regulatory agency has demanded a comprehensive remediation plan within 15 working days and warned that approval of new drug applications may be withheld until full compliance with Current Good Manufacturing Practice regulations is confirmed.
- The U.S. Food and Drug Administration has issued a warning letter to Granules India citing significant Good Manufacturing Practice (GMP) violations at its Telangana manufacturing plant. - Inspectors identified multiple deficiencies related to improper maintenance of storage facilities and manufacturing equipment, raising concerns about product quality and contamination risks. - The regulatory action could potentially impact Granules India's ability to export pharmaceutical products to the U.S. market until the company implements corrective measures and passes re-inspection.
