NSEPress Release17h ago · 30 Oct 2026, 10:51 pm

Press Release

Granules India Limited · GRANULES

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Granules India Limited has informed the Exchange regarding a press release dated October 30, 2026, titled 'Granules India's Gagillapur facility completes USFDA inspection with eleven observations'. The inspection was conducted from October 19 to October 30, 2026, and concluded with the issuance of a Form FDA 483 containing eleven observations. None of the observations were related to data integrity or cross-contamination.

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Granules India Limited has informed the Exchange regarding a press release dated October 30, 2026, titled "Granules India s Gagillapur facility completes USFDA inspection with eleven observations".

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Dated: October 30, 2026 National Stock Exchange of India Limited BSE Limited Symbol: NSE: GRANULES; BSE: 532482 Sub: Press Release Dear Sir, We are herewith enclosing the press release given by the Company. This is for your information and dissemination to the members of the exchange. Thanking You. Yours sincerely, For GRANULES INDIA LIMITED CHAITANYA TUMMALA (COMPANY SECRETARY & COMPLIANCE OFFICER) Encl. as above REGISTERED OFFICE Granules India Limited CIN: L24110TG1991PLC012471 15th Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad – 500084, Telangana, India Contact Us: Tel: +91-40-69043500 |Fax: +91-40-23115145| mail@granulesindia.com www.granulesindia.com Press Release Granules India’s Gagillapur facility completes USFDA inspection with eleven observations Hyderabad, India, October 30, 2026 – Granules India Limited today announced that the United States Food and Drug Administration (USFDA) has concluded a current Good Manufacturing Practice inspection of its finished dosage facility at Gagillapur, Hyderabad. The inspection was conducted from October 19 to October 30, 2026, and concluded with the issuance of a Form FDA 483 containing eleven observations. This was the first USFDA inspection of the facility since the Warning Letter of February 26, 2025, which followed an inspection in August - September 2024. None of the observations were related to data integrity or cross-contamination. The observations relate to enhancements in investigations, change control, process and equipment qualification, visual-inspection controls and documentation practices. There is no impact on manufacturing or distribution of products from the site. Granules will submit a comprehensive response to the USFDA within the stipulated 15 business days. Commenting on the inspection, Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, said: “The inspection progressed constructively, and the observations are of a nature that we believe can be fully addressed through our responses and corrective and preventive actions. Quality is the foundation of everything we do at Granules, and we will continue to engage transparently with the agency.” ***END*** CIN: L24110TG1991PLC012471 / Granules India Limited: 15th Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad – 500084, Telangana, India. 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), Finished Dosages (FDs) and Peptides CDMO. 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, Germany, Canada and Switzerland. The Company has 11 manufacturing facilities out of which 8 are in India, 2 in the USA and 1 in Switzerland and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL. For more information about Granules India Ltd and its initiatives, please visit www.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. Contacts: Investors Contact: Media Contact: Chaitanya Tummala Corporate Communications Company Secretary GILCorporateCommunication@granulesindia.com 040-69043614 chaitanya.tummala@granulesindia.com CIN: L24110TG1991PLC012471 / Granules India Limited: 15th Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad – 500084, Telangana, India.