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Friday, January 09, 2026 , BSE Sensex : 83,767.98 83,767.98(-0.49%) , Adani Ports : 1,438.90 1,438.90(-1.76%) , Asian Paints : 2,819.55 2,819.55(1.18%) , Axis Bank : 1,274.05 1,274.05(-0.99%) , Bajaj Finance : 966.25 966.25(-0.57%) , Bajaj Finserv : 1,987.95 1,987.95(-1.04%) , Bharat Electron : 419.75 419.75(0.99%) , Bharti Airtel : 2,053.45 2,053.45(-0.62%) , Eternal : 288.60 288.60(1.80%) , HCL Technologies : 1,669.80 1,669.80(1.31%) , HDFC Bank : 940.30 940.30(-0.67%) , Hind. Unilever : 2,369.40 2,369.40(-0.72%) , ICICI Bank : 1,403.90 1,403.90(-2.19%) , Infosys : 1,619.45 1,619.45(0.39%) , Interglobe Aviat : 4,857.25 4,857.25(-0.96%) , ITC : 338.00 338.00(-0.85%) , Kotak Mah. Bank : 2,121.65 2,121.65(-0.53%) , Larsen & Toubro : 4,023.10 4,023.10(-0.12%) , M & M : 3,704.35 3,704.35(-0.53%) , Maruti Suzuki : 16,455.00 16,455.00(-1.25%) , NTPC : 340.45 340.45(-1.06%) , Power Grid Corpn : 260.15 260.15(0.25%) , Reliance Industr : 1,468.50 1,468.50(-0.12%) , SBI : 1,003.80 1,003.80(0.60%) , Sun Pharma.Inds. : 1,744.75 1,744.75(-0.95%) , Tata Steel : 180.10 180.10(-0.06%) , TCS : 3,212.00 3,212.00(0.24%) , Tech Mahindra : 1,587.90 1,587.90(0.66%) , Titan Company : 4,219.25 4,219.25(-0.66%) , Trent : 3,970.10 3,970.10(-0.47%) , UltraTech Cem. : 11,911.00 11,911.00(-1.23%) ,

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08-Jan-2026     09:23
Granules receives USFDA approval for generic Amphetamine Extended-Release Tablets

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.

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