Granules India Limited has informed the Exchange regarding a press release dated January 08, 2026, titled "CIN: L24110TG1991PLC012471 / Granules India Limited: 15th Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad 500084, Telangana, India.Press ReleaseGranules Pharmaceuticals, Inc. Receives FDA Tentative Approval with 180-Day Exclusivity for Generic Amphetamine Extended-Release Tablets (gDYANAVEL XR)".
GRANULES · price
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Granules Pharmaceuticals Inc., the wholly-owned US subsidiary of Granules India, has received FDA Tentative Approval for its generic version of DYANAVEL XR (Amphetamine Extended-Release Tablets) in 5 mg, 10 mg, 15 mg, and 20 mg strengths, used to treat ADHD. The product qualifies for 180-day market exclusivity in the US, addressing an estimated USD 41 million market opportunity. This is the company's second consecutive FDA tentative approval within a few weeks, following the December 22, 2025 approval for generic ADZENYS XR-ODT, which targets a much larger USD 172 million market. The approvals reinforce Granules' focus on complex generics and expanding its presence in the central nervous system (CNS) therapy segment in the US.
Positive for shareholders — 180-day exclusivity offers a strong competitive edge and potential pricing power in the US market, while back-to-back approvals signal strong R&D and regulatory execution that could drive future revenue and margin growth.