Granules India rises as its arm gets USFDA`s nod for Lisdexamfetamine dimesylate chewable tablets
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Granules India is currently trading at Rs. 589.90, up by 5.55 points or 0.95% from its previous closing of Rs. 584.35 on the BSE.
The scrip opened at Rs. 580.80 and has touched a high and low of Rs. 591.00 and Rs. 576.95 respectively. So far 41865 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 724.55 on 02-Sep-2024 and a 52 week low of Rs. 365.70 on 21-Dec-2023.
Last one week high and low of the scrip stood at Rs. 592.00 and Rs. 556.55 respectively. The current market cap of the company is Rs. 14274.39 crore.
The promoters holding in the company stood at 38.87%, while Institutions and Non-Institutions held 34.34% and 26.80% respectively.
Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc., 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.
The company 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. The company now holds 68 ANDA approvals, including 30 ANDAs from GPI.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
