Thursday, July 18, 2024

Granules Consumer Health Inc., concludes FDA Audit with Zero Observations

Hyderabad, 21 March 2023: Granules India announced that Granules Consumer Health Inc. (GCH), a step-down subsidiary of the Company and a wholly owned subsidiary of Granules USA, Inc., has completed an audit by the U.S. Food and Drug Administration (US FDA) with zero 483s. 

The facility was inspected by the US FDA from 15th to 20th March 2023. “The audit is a pre-approval inspection for three products filed from the facility. The packaging site strengthens our proposition to control the value chain and provides us with the agility needed in a very dynamic OTC space,” said Priyanka Chigurupati, Executive- Director, Granules USA, Inc.& Granules Pharmaceuticals, Inc.

Granules Consumer Health (GCH) is a leading private-label OTC provider, and its packaging facility will enable it to service leading retailers more effectively.

The packaging facility in Manassas is spread over 79,000 sq ft and has several packaging suites to service customer needs.

Granules Consumer Health (GCH) was established in 2014, to offer OTC generics that meet the highest level of quality at an affordable cost.

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

Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and a commitment to operational excellence, quality, and customer service. Amongst the few pharmaceutical companies in the world to be present across the manufacturing of the entire pharmaceutical value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs), Granules products are 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.


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