Granules India Limited today announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets USP, 250 mg, 500 mg, 750 mg, and 1,000 mg. bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Keppra Tablets of UCB, Inc. (UCB), the company announced through an exchange filing.
Granules now has a total of 58 ANDA approvals from US FDA (56 Final approvals and 2 tentative approvals).
The current annual U.S. market for Levetiracetam Tablets is approximately $247 Million, according to MAT Mar 2023, IQVIA/IMS Health.
Levetiracetam Tablets are indicated as adjunctive therapy in the treatment of Partial onset seizures in adults and infants of age 1 month and older children with epilepsy; Myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy, and Primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Granules India Ltd Shares
The shares of granules India on Wednesday at 11:15 am IST were at Rs 288.20, up by one percent.
About the Company
Granules India Limited, incorporated in 1991 is an Indian pharmaceutical company headquartered at Hyderabad. It is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain — from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL. Get more information.