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Granules India Ltd. — Capital/Financing Update 2025
Dec 22, 2025
60224_rns_2025-12-22_99f60119-2c06-4733-a8e8-71389440346b.pdf
Capital/Financing Update
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Dated: December 22, 2025
To, National Stock Exchange of India Limited BSE Limited Symbol: NSE: GRANULES; BSE: 532482
Sub: Press Release
Dear Sir/Mam,
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.
For GRANULES INDIA LIMITED
CHAITANYA TUMMALA Digitally signed by CHAITANYA TUMMALA DN: c=IN, postalCode=500013, st=TELANGANA, street=2-2-186184,RAMAKRISHNA NAGAR,GOLDEN HARMONY,AMBERPETHYDERABAD, l=HYDERABAD, o=Personal, serialNumber=ae6c5085a4c307805711d3f1ab8a1ff2da48346a26aa5fe898e52ec0775c3c69, pseudonym=a5f653fd8e1843f29a1ab44abbf7a768, 2.5.4.20=2cfb55dced7656dd21a7df6cb09fe2f5434713581663a856d7626e206b1defb5, [email protected], cn=CHAITANYA TUMMALA Date: 2025.12.22 07:39:44 +05'30'
CHAITANYA TUMMALA (COMPANY SECRETARY & COMPLIANCE OFFICER)
REGISTERED OFFICE
Granules India Limited
CIN: L24110TG1991PLC012471
15[th ] Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad – 500084, Telangana, India Contact Us: Tel: +91-40-69043500 |Fax: +91-40-23115145| [email protected]
www.granulesindia.com
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Press Release
Granules Pharmaceuticals Inc. Receives FDA Tentative Approval for Generic Amphetamine Extended-Release Orally Disintegrating Tablets (ADZENYS XR-ODT®)
Hyderabad, December 22, 2025 – Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, the generic equivalent of ADZENYS XR-ODT®. It will be manufactured at Granules’ US-based facility located in Chantilly, Virginia.
The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of approximately USD 172 million according to IQVIA (IMS Health).
Currently, the market has only one approved generic and one authorised generic , positioning Granules favourably to expand access to this critical therapy upon launch.
Commenting on the development, the Chairman and Managing Director, Dr. Krishna Prasad Chigurupati, stated: “The tentative approval of this ANDA reaffirms Granules’ strategic focus on expanding its portfolio of complex and differentiated generics while strengthening its presence in the central nervous system (CNS) therapeutic area. ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the United States and impacts hundreds of millions of people worldwide. At Granules, we remain committed to improving patient access by delivering high-quality, affordable medications across global markets.”
This approval further strengthens Granules’ US generics portfolio and underscores its continued investments in complex dosage forms, patient-friendly delivery technologies, and value-driven healthcare solutions.
END
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 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.
CIN: L24110TG1991PLC012471 / Granules India Limited: 15th Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad – 500084, Telangana, India.
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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 “forwardlooking 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 Corporate Communications [email protected] |
Investors Contact: Chaitanya Tummala Company Secretary 040-69043614 [email protected] |
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CIN: L24110TG1991PLC012471 / Granules India Limited: 15th Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad – 500084, Telangana, India.