Granules India

Granules India Ltd. has received approval from the U.S. Food and Drug Administration (USFDA) for a generic medication used in the treatment of attention deficit hyperactivity disorder (ADHD), marking a meaningful advance in its regulated markets strategy. The clearance enables the company to manufacture and market the product in the United States, the world’s largest pharmaceutical market by value. The development underscores Granules’ growing capabilities in complex generics and reinforces its focus on expanding its central nervous system (CNS) portfolio.

Granules India has received regulatory clearance from the U.S. Food and Drug Administration to market a generic medication used in the treatment of attention deficit hyperactivity disorder. The approval strengthens the company’s presence in the regulated U.S. pharmaceutical market and adds a high-value product to its portfolio. Analysts say the development could support revenue growth over the medium term, given the strong demand for cost-effective ADHD therapies.

Granules India, a prominent pharmaceutical manufacturer, has initiated a voluntary recall of certain lots of its blood pressure medication in the United States. The decision follows observations of process-related deviations that could compromise product quality. While no adverse events have been reported to date, the company chose to act preemptively in coordination with US regulators. This development underscores the critical importance of stringent quality controls in the pharmaceutical sector, particularly for medications treating chronic conditions like hypertension.

Granules India delivered a robust financial performance in the quarter ended March 31, 2025, with consolidated profit after tax (PAT) rising 17% year-over-year to Rs 152 crore, buoyed by an 18% growth in its high-margin formulations segment. Despite a marginal revenue dip in FY25 to Rs 4,482 crore from Rs 4,506 crore the prior year, the Hyderabad-based pharmaceutical company maintained steady sales and strong cash flow. Strategic emphasis on product mix optimization and expansion of non-legacy molecules underpinned the firm’s resilient profitability.