Zydus Lifesciences Limited

ZYDUSLIFE

INE010B01027

Pharmaceuticals

Delayed NSE India S.E. Other stock markets 07:41:02 2026-01-14 am EST			5-day change	1st Jan Change
883.75 ^INR	-1.88%		-4.72%	-3.35%

04:07am	Zydus Lifesciences Gets US FDA's Final Nod for Platelet Deficiency Drug	MT
Jan. 13	US FDA approves Fortress Bio and Zydus' treatment for a rare pediatric disease	RE

Zydus Lifesciences Limited Receives Final Approval from USFDA for Diroximel Fumarate Delayed-Release Capsules, 231 mg

Published on 11/13/2025 at 03:27 am EST

S&P Capital IQ

Zydus Lifesciences Limited

-1.88%

Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg (USRLD: Vumerity Delayed-Release Capsules, 231 mg). Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Diroximel fumarate delayed-release capsules will be produced at Zydus Lifesciences Ltd, SEZ.

Diroximel fumarate delayed-release capsules had annual sales of USD 999.4 mn in the United States (IQVIA MAT Sept-2025). The group now has 426 approvals and has so far filed 487* ANDAs since the commencement of the filing process in Fiscal Year 2003-04.

Latest news about Zydus Lifesciences Limited

04:07am	Zydus Lifesciences Gets US FDA's Final Nod for Platelet Deficiency Drug	MT
Jan. 13	US FDA approves Fortress Bio and Zydus' treatment for a rare pediatric disease	RE
Jan. 13	Zydus Lifesciences Receives US FDA Nod for Rare Pediatric Disease Drug	MT
Jan. 09	FDA approves first generic robenacoxib tablet for postoperative pain in cats	RE
Jan. 02	Zydus Lifesciences' Luxembourg-Based Subsidiary Auroralux Gets Dissolved	MT
Dec. 30	Zydus Lifesciences gets tax demand order of 28 million rupees	RE
Dec. 24	Zydus Lifesciences and Sterling Biotech extend API business acquisition closing to June 30	RE
Dec. 23	Lilly, Novo lock horns in India's obesity drug race	RE
Dec. 23	Formycon Obtains US FDA Approval for Interchangeable Lucentis Biosimilar	MT
Dec. 23	Zydus Lifesciences partners with bioeq for U.S. rights to NUFYMCO	RE
Dec. 19	Indian Equities Rebound on Friday as Rupee Stability Lifts Sentiment	MT
Dec. 19	Zydus Lifesciences Signs Pact to Launch Cancer-Risk Assessment Diagnostic Tests in India	MT
Dec. 18	Zydus Lifesciences signs agreement with Myriad Genetics for cancer-risk tests in India	RE
Dec. 18	Zydus Lifesciences Limited Signs an Exclusive Agreement with Myriad Genetics	CI
Dec. 15	Zydus Lifesciences says FDA accepts Sentynl's CUTX-101 NDA resubmission	RE
Dec. 10	Indian Equities Extend Losses as Investors Turn Cautious Ahead of US Rate Decision	MT
Dec. 10	Zydus Lifesciences Launches Denosumab Biosimilar	MT
Dec. 09	Zydus Lifesciences launches biosimilar denosumab 120 mg SC	RE
Dec. 09	Zydus Lifesciences Limited Launches Biosimilar Denosumab 120 Mg Sc - Protecting Bone Health in Cancer Patients	CI
Dec. 09	Formycon, Zydus Sign Exclusive Deal for Keytruda Biosimilar in US, Canada	MT
Dec. 09	Formycon Secures Additional Commercialization Partnership for Keytruda Biosimilar	DP
Dec. 09	Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206	RE
Dec. 04	Zydus Lifesciences Gets US FDA's Establishment Inspection Report for Jarod, India Unit	MT
Dec. 04	Zydus Lifesciences receives EIR for injectable facility located at Jarod	RE
Nov. 27	Zydus Lifesciences receives tentative approval from USFDA for empagliflozin and linagliptin tablets	RE

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Company Profile

Zydus Lifesciences Limited is an India-based global life sciences company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The Company is engaged in the business of integrated pharmaceutical operations. Its product portfolio includes active pharmaceutical ingredients (API), human formulations, animal health and veterinary, health, and wellness products. Its products include India formulations, Generics and Zydus biologics. The Company's products include Lipaglyn and Bilypsa (Saroglitazar), Ujvira (Trastuzumab emtansine biosimilar), Exemptia (Adalimumab biosimilar), Vivitra (Trastuzumab biosimilar) and Bryxta (Bevacizumab biosimilar). Its Zydus biologics covers various therapeutic areas, such as oncology, autoimmune disease, nephrology, inflammation, rheumatology, hepatology and infectious illnesses, among others. The Company has a global presence and markets its products in the United States, India, Europe and emerging markets.

Employees

27,917

Sector

Pharmaceuticals

Calendar

Feb. 04 - Q3 2026 Earnings Release (Projected)

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