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Granules India Limited Receives ANDA Approval for Levetiracetam Tablets in record 9 months

  • Granules now have a total of 56 ANDA final approvals from the US FDA
  • 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

Hyderabad, 14 June 2023: 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).

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 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.

About Granules India Ltd. (BSE: 532482, NSE: GRANULES)

Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad with best in class facilities and commitment to operational excellence, quality, and customer service. We are 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). Our products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, U.S. and U.K. 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 on https://granulesindia.com

Safe Harbor: This document is to provide the general background information about the Company’s activities as at the date of the release. The information contained herein is for general information purposes only and based on estimates and should not be considered as a recommendation that any investor should subscribe / purchase the company shares. The Company makes no representation or warranty, express or implied, as to, and does not accept any responsibility or liability with respect to, the fairness, accuracy, completeness or correctness of any information contained herein. This release may include certain “forward looking statements”. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from these statements. Important factors that could cause actual results to differ materially from our expectations include, amongst others general economic and business conditions in India, ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currencies, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global pharmaceuticals industries, increasing competition, changes in political conditions in India or any other country and changes in the foreign exchange control regulations in India. Neither the company, nor its directors and any of the affiliates or employees have any obligation to update or otherwise revise any forward-looking statements. The readers may use their own judgment and are advised to make their own calculations before deciding on any matter based on the information given herein. No part of this release may be reproduced, quoted or circulated without prior written approval from Granules India Limited.

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