Zydus Lifesciences Limited

ZYDUSLIFE

INE010B01027

Pharmaceuticals

Market Closed - NSE India S.E. Other stock markets 06:49:39 2025-01-22 am EST			5-day change	1st Jan Change
978.50 ^INR	-0.75%		-2.16%	+0.70%

Jan. 20	Zydus Lifesciences Gets USFDA Nod for Phase II(b) Trial of Usnoflast in ALS	MT
Jan. 18	Zydus Lifesciences Receives Approval from USFDA to Conduct Phase II(B) Clinical Trial for Usnoflast	CI

Zydus Lifesciences Limited Receives Warning Letter Issued by the USFDA

August 30, 2024 at 04:21 am EDT

Zydus Lifesciences Limited informed that the Company has received a Warning Letter issued by the USFDA relating to its Injectables manufacturing facility at Jarod near Vadodara. The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. The Warning Letter does not contain any data integrity related violations.

This is further to communication dated July 18, 2024, about Jarod facility receiving OAI status by the USFDA. This site was inspected by USFDA from April 15 to April 23, 2024. The contents of the Warning Letter shall be made public by the USFDA in due course.

The Company will take all necessary steps to work with USFDA towards earliest remediation of the above facility.

Latest news about Zydus Lifesciences Limited

Zydus Lifesciences Gets USFDA Nod for Phase II(b) Trial of Usnoflast in ALS	Jan. 20	MT
Zydus Lifesciences Receives Approval from USFDA to Conduct Phase II(B) Clinical Trial for Usnoflast	Jan. 18	CI
Nomura Upgrades Zydus Lifesciences to Buy From Neutral, Adjusts Price Target to INR1,140 From INR1,030	Jan. 10	MT
CVS Health Unit to Include Zydus Lifesciences' Diabetes Medications in Template Formulary	Jan. 07	MT
Zydus Announces Agreement with CVS Caremark to Add Zituvio Tm, Zituvimettm and Zituvimettm XR (Sitagliptin \| Sitagliptin and Metformin Hydrochloride) to Its Template Formulary	Jan. 06	CI
Zydus Lifesciences Limited Appoints Vikram Shukla as a President-Parenteral Operations	Jan. 03	CI
Zydus Lifesciences Gets Final Approval from US FDA for Lidocaine and Prilocaine Cream	Dec. 19	MT
Zydus Lifesciences Limited Receives Final Approval from USFDA for Lidocaine and Prilocaine Cream USP, 2.5%/2.5%	Dec. 19	CI
Zydus Lifesciences Limited Receives Demand Order-In-Original from Assistant Commissioner, Division Dehradun, Sector-7, Uttarakhand	Nov. 28	CI
Nomura Adjusts Zydus Lifesciences' Price Target to INR1,030 From INR1,020, Keeps at Neutral	Nov. 14	MT
Jefferies Adjusts Zydus Lifesciences' Price Target to INR1,380 From INR1,450, Keeps at Buy	Nov. 13	MT
Zydus Lifesciences Posts Gains in Fiscal Q2 Consolidated Net Profit	Nov. 13	MT
Zydus Lifesciences Limited, Q2 2025 Earnings Call, Nov 12, 2024	Nov. 12
India's Zydus Life posts Q2 profit rise on steady US demand	Nov. 12	RE
Zydus Lifesciences Limited Reports Earnings Results for the Second Quarter and Six Months Ended September 30, 2024	Nov. 12	CI
Zydus Lifesciences Limited Receives in Principle Acceptability from World Health Organization for Zyvac Tcv	24-10-23	CI
Zydus Lifesciences Limited Receives Final Approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 Mg	24-10-17	CI
Zydus Lifesciences to Start Phase 2 Trials of Desidustat for Sickle Cell Disease	24-10-14	MT
Zydus Lifesciences Limited and ICMR Initiate A Phase 2 Proof-Of-Concept Trial of Desidustat in Patients with Sickle Cell Disease	24-10-14	CI
Zydus Lifesciences Limited Receives Final Approval from USFDA for Paliperidone Extended-Release Tablets	24-10-10	CI
Zydus Lifesciences Gets Tentative Nod from US FDA for Enzalutamide Tablets	24-10-02	MT
Zydus Receives Tentative Approval from USFDA for Enzalutamide Tablets, 40 Mg and 80 Mg	24-10-02	CI
Zydus Lifesciences Limited Receives Final Approval from USFDA for Enzalutamide Capsules, 40 Mg	24-09-28	CI
Zydus Lifesciences Limited and CSIR-Central Drug Research Institute Lucknow to Develop Best-In-Class Drug for Chronic Kidney Disease Induced Osteoporosis	24-09-27	CI
Zydus Lifesciences to Acquire Active Pharmaceutical Ingredients Business of Sterling Biotech	24-09-17	MT

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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

26,921

Sector

Pharmaceuticals

Calendar

2025-02-04 - Q3 2025 Earnings Release

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