NSEPress Release6 Jul 2026 · 6 Jul 2026, 08:39 am
Press Release
Granules India Limited · GRANULES
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Granules India Limited has secured Sole First-to-File ANDA status for Sodium Oxybate Extended-Release for Oral Suspension, a generic equivalent of LUMRYZ, marking its second such achievement in the complex generics segment.
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Granules India Limited has informed the Exchange regarding a press release dated July 06, 2026, titled "Granules India Limited Secures Sole First-to-File ANDA Status for Sodium Oxybate Extended-Release for Oral Suspension ".
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Dated: July 06, 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 Limited Secures Sole First-to-File ANDA Status for Sodium
Oxybate Extended-Release for Oral Suspension
Hyderabad, India - July 6, 2026 — Granules India Limited announced that it has secured Sole First-to-File
(FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral
Suspension, the generic equivalent of LUMRYZ® extended-release oral suspension.
This achievement marks Granules’ second Sole First-to-File ANDA, following its earlier success with
Amphetamine Extended-Release Tablets, the generic equivalent of Dyanavel XR®, and further demonstrates
the company’s growing capabilities in developing and advancing complex, differentiated generic products for the
U.S market.
“Securing Sole First-to-File status for our Sodium Oxybate Extended Release for Oral Suspension ANDA
is another important milestone in our complex generics journey. This achievement reflects the strength
of our R&D and regulatory capabilities, while reinforcing our commitment to building a differentiated
portfolio. We remain focused on expanding patient access to affordable treatment options and delivering
sustainable long-term growth.”
— Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India Limited
The Sole First-to-File designation further strengthens Granules position in the complex generics segment and
underscores the Company’s continued focus on innovation, execution excellence, and strategic portfolio
expansion in regulated markets.
LUMRYZ® (sodium oxybate) extended-release oral suspension is indicated in the United States for the treatment
of cataplexy or excessive daytime sleepiness in patients with narcolepsy. LUMRYZ® is a registered trademark
of Alkermes plc or its affiliates.
** 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 in Hyderabad, with best-in-class facilities and a commitment to operational excellence, quality, and customer
service. We are among the few pharmaceutical companies in the world to be present across the entire manufacturing value chain
— from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs) to
Peptides CDMO. Our products are distributed to more than 300 customers across regulated and semi-regulated markets, with a
global presence extending to over 80 countries and offices across India, the US, and Switzerland. The Company has 10
manufacturing facilities, of which seven are in India, two are in the US, and one is 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 provides general background information about the Company’s activities as of the date of this release.
The information contained herein is for general information purposes only, is based on estimates, and should not be considered a
recommendation that any investor should subscribe to or purchase the Company’s shares. The Company makes no representation
or warranty, express or implied, 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, among 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; technological
changes; changes in the value of the Rupee and other currencies; changes in Indian and international interest rates; changes in
laws and regulations that apply to Indian and global pharmaceutical industries; increasing competition; changes in political
conditions in India or any other country; and changes in foreign exchange control regulations in India. Neither the Company nor
its directors, affiliates, or employees have any obligation to update or otherwise revise any forward-looking statements. 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: Investors Contact:
Priyanka Chawla Chaitanya Tummala
Corporate Communications Company Secretary
priyanka.chawla@granulesindia.com chaitanya.tummala@granulesindia.com
CIN: L24110TG1991PLC012471 / Granules India Limited: 15th Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad – 500084, Telangana, India.