Granules India gets USFDA’s approval for Levetiracetam Tablets

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 have a total of 58 ANDA approvals from the USFDA (56 Final approvals and 2 tentative approvals). The current annual U.S. market for Levetiracetam Tablets is around USD 247 million, according to MAT March 2023, IQVIA/IMS Health.   

Granules India is a manufacturer and supplier of pharmaceutical products. The company operates in more than 80 countries with 52 percent of revenue share coming from North America, 21% from Europe, 10% from Latin America, 12% from India, and the remaining from the rest of the world. The company differentiates itself by economies of scale, growth-oriented portfolio and vertical integration. 

Today, the stock opened at Rs 285.75, with a high and low of Rs 289.00 and Rs 285.50. The stock closed trading at Rs 287.10, up by 0.54%. The stock has a 52-week high of Rs 381.25 and a 52-week low of Rs 227.00. The company has a ROCE of 19.4% and an ROE of 19.1% with a market capitalisation of Rs 7,128 crore.