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01-01-1970 12:00 AM | Source: Accord Fintech
Granules India gains as its arm receives ANDA approval for Amphetamine Mixed Salts ER Capsules
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Granules India is currently trading at Rs. 313.30, up by 1.20 points or 0.38% from its previous closing of Rs. 312.10 on the BSE.

The scrip opened at Rs. 312.60 and has touched a high and low of Rs. 314.70 and Rs. 311.00 respectively. So far 5821 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 381.25 on 04-Nov-2022 and a 52 week low of Rs. 227.00 on 20-Jun-2022.

Last one week high and low of the scrip stood at Rs. 316.35 and Rs. 307.70 respectively. The current market cap of the company is Rs. 7554.15 crore.

The promoters holding in the company stood at 42.02%, while Institutions and Non-Institutions held 28.41% and 29.56% respectively.

The US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly-owned foreign subsidiary of Granules India, for Amphetamine Mixed Salts, 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg Extended-Release (ER) capsules. It is bioequivalent to the reference listed drug product (RLD), Adderall XR Extended-Release capsules of Takeda Pharmaceuticals USA Inc. This product will be manufactured at Granules manufacturing facility in Chantilly, Virginia and is expected to be launched shortly.

Mixed Salts of a Single-Entity Amphetamine ER Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Granules now have a total of 53 ANDA approvals from US FDA (51 Final approvals and 2 tentative approvals). The current annual U.S. market for Amphetamine Mixed Salts ER capsule product is approximately $1.56 Billion, according to MAT Nov 2022, IQVIA/IMS Health.

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).