Granules India has received approval from the US Food & Drug Administration (USFDA) for 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).
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; Primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Granules now has a total of 58 ANDA approvals from USFDA (56 Final approvals and 2 tentative approvals).The current annual U.S. market for Levetiracetam Tablets is around $247 million, according to MAT March 2023, 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).
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1540.15 |
Dr. Reddys Lab | 6058.80 |
Cipla | 1389.95 |
Zydus Lifesciences | 1006.95 |
Lupin | 1612.20 |
View more.. |