GRANULES INDIA LIMITED Press Release | For Immediate Release |
Granules India Limited Received ANDA Approval for
Loperamide Hydrochloride and Simethicone Tablets
Hyderabad, 30 August 2022: Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC). It is bioequivalent to the reference listed drug product, Imodium Multi-Symptom Relief Tablets, 2 mg/125 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.
Loperamide Hydrochloride and Simethicone Tablets are indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.
Granules now have a total of 52 ANDA approvals from US FDA (50 Final approvals and 2 tentative approvals).
The Imodium Multi-Symptom Relief ®️ brand and store brands had combined U.S. sales of approximately $60 million MAT for the most recent twelve months.
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CIN: L24110TG1991PLC012471 / Granules India Limited: 2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad- 500081
Contact:
Krishna Raghunathan | Chaitanya Tummala |
Vice President - Finance and Investor Relations | Company Secretary |
040-69043573 | 040-69043614 |
krishna.raghunathan@granulesindia.com | chaitanya.tummala@granulesindia.com |
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, US and UK. The Company has 7 manufacturing facilities out of which 6 are 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.
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.
CIN: L24110TG1991PLC012471 / Granules India Limited: 2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad- 500081
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Granules India Limited published this content on 30 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 August 2022 06:03:09 UTC.
