This facility manufactures APIs & formulations of oncology and non-oncology products.
Hyderabad, April 13, 2024: Granules India Limited, announced that the Company’s Unit V facility located at Anakapally, Visakhapatnam, Andhra Pradesh, India has successfully completed the US Food and Drug Administration (FDA) inspection between 8th and 12th April 2024, resulting in zero 483 observations.
This audit was a Pre-Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and Formulations (FDs) for oncology and non-oncology products.
According to Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India, “We are very proud to reiterate that our focus on high-quality standards is comparable to the best global benchmarks as we receive zero observations from US FDA audits. We will continue to move ahead and manufacture products that will enhance health care.”
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 10 manufacturing facilities out of which 8 are located in India and 2 are in the USA and has regulatory approvals from the US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL. Get more information: https://granulesindia.com
Safe Harbor: This document is to provide 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 is 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, the 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.