Press Release
Granules India's Unit I Facility Secures US FDA EIR with 'Voluntary Action Indicated' (VAI) Hyderabad, October 29, 2025: Granules India Limited, a leading pharmaceutical manufacturing company, is pleased to announce that it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its API Unit-I facility located at Bonthapally, Hyderabad. The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025.There was one observation during that inspection, and the Company had submitted its response within the stipulated time.
"The successful completion of this US FDA inspection and the subsequent receipt of the EIR with a satisfactory VAI classification reflects our commitment to maintaining the highest quality standards in our manufacturing operations," said Dr. Krishna Prasad Chigurupati, Chairman & Managing Director.
This facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume. Along with Paracetamol APIs, the Company has established Metformin and Guaifenesin API manufacturing plants in the same facility.
The company remains dedicated to producing top-quality pharmaceutical products that meet global health standards.
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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.
Media Contact: Priyanka Chawla Manager- Corporate Communications priyanka.chawla@granulesindia.com | Investors Contact: Chaitanya Tummala Company Secretary 040-69043614 chaitanya.tummala@granulesindia.com |