NSEPress Release7 Oct 2026 · 7 Oct 2026, 12:41 pm
Press Release
Granules India Limited · GRANULES
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Granules India Limited has submitted a Paragraph IV certification for its ANDA for Ruxolitinib Extended-Release Tablets, which may make it eligible for first-to-file status and 180 days of generic drug exclusivity in the US.
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Granules India Limited has informed the Exchange regarding a press release dated October 07, 2026, titled "Press Release".
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Dated: October 07, 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 Gains Potential Sole First to File Status on Ruxolitinib Extended-Release Tablets
ANDA
Hyderabad, India - October 7, 2026 — Granules India Limited announced that it has submitted a Paragraph IV
certification in connection with its ANDA for Ruxolitinib Extended-Release Tablets with respect to applicable
patents listed in the U.S. Food and Drug Administration’s (FDA) Orange Book and has provided the required
notice to the relevant parties in accordance with applicable U.S. regulatory requirements.
Based on the timing and status of its ANDA and Paragraph IV certification and subject to FDA review
and determination, GIL believes that it is eligible for first-to-file status for Ruxolitinib Extended-Release
Tablets. If confirmed by the FDA and all applicable statutory and regulatory requirements are satisfied,
first-to-file status may provide eligibility for 180 days of generic drug exclusivity under U.S. law.
The ANDA also remains subject to FDA review, and this announcement should not be construed as FDA
approval of the product or confirmation by the FDA of first-to-file status or exclusivity.
Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman & Managing Director,
Granules India Limited, said:
“First-to-file opportunities are an important part of our strategy to build a more differentiated and higher-value
product portfolio in the U.S. This filing reflects our focus on identifying technically and commercially attractive
opportunities where our development and manufacturing capabilities can create sustainable value. We look
forward to progressing the product through the regulatory process.”
The Company will provide further updates, as appropriate, in accordance with applicable disclosure
requirements.
This communication contains forward-looking statements relating to, among other things, the Company's ANDA,
potential first-to-file status, possible eligibility for 180-day exclusivity, regulatory review, and commercialization
prospects. Such statements are subject to risks and uncertainties, including those relating to FDA actions, patent
litigation, exclusivity determinations, competition, and other factors, and actual outcomes may differ materially
from those expressed or implied herein.
** 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.