Granules India announced today that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Chewable Tablets. The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg. This generic drug product has been determined to be bioequivalent (AB Rating) to the reference listed drug, Vyvanse� Chewable Tablets by Takeda Pharmaceuticals USA Inc. Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged six years and older, as well as Moderate to Severe Binge Eating Disorder (BED) in adults. Granules has received approval in the first review cycle, reflecting the company`s consistent focus on regulatory excellence and expedited product delivery. Lisdexamfetamine Dimesylate Chewable Tablets are currently published on the FDA Drug Shortages List, emphasizing their critical role in patient care. Powered by Capital Market - Live News

Granules India has received validation and approval from the Science Based Targets initiative (SBTi) for its near-term, long-term, and net-zero goals. These targets, aligned with the 1.5�C pathway, set Granules apart as one of the select Indian pharmaceutical companies with SBTi-validated targets under the initiative`s new guidelines. Granules` goals are notable for their comprehensive scope and ambition. Granules India has committed to achieving net-zero greenhouse gas (GHG) emissions across its value chain, including all subsidiaries, by FY2050. In the near term, the company targets a 42% reduction in absolute Scope 1 and 2 emissions and Scope 3 emissions by FY2030, using FY2023 as the baseline, alongside transitioning to 100% renewable electricity. These near-term and long-term targets are aligned with the 1.5�C pathway, emphasizing Granules` dedication to ambitious climate action and achieving net-zero well before FY2050. Powered by Capital Market - Live News

Net profit of Granules India declined 4.79% to Rs 97.23 crore in the quarter ended September 2024 as against Rs 102.12 crore during the previous quarter ended September 2023. Sales declined 19.48% to Rs 956.52 crore in the quarter ended September 2024 as against Rs 1188.00 crore during the previous quarter ended September 2023. ParticularsQuarter EndedSep. 2024Sep. 2023% Var. Sales956.521188.00 -19 OPM %21.2617.93 - PBDT180.91188.54 -4 PBT128.38136.02 -6 NP97.23102.12 -5 Powered by Capital Market - Live News

Granules India announced today that the U.S. Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets USP (SR) 100 mg, 150 mg, and 200 mg filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company. Bupropion Hydrochloride Extended-Release Tablets USP (SR) are bioequivalent and therapeutically equivalent to Wellbutrin SR Sustained-Release Tablets, 100 mg, 150 mg, and 200 mg, by GlaxoSmithKline LLC. This is a widely prescribed medication for the treatment of major depressive disorder and for the prevention of seasonal affective disorder. Granules now has a total of 67 ANDA approvals from the US FDA.Powered by Capital Market - Live News

Granules India will hold a meeting of the Board of Directors of the Company on 6 November 2024.Powered by Capital Market - Live News