Zydus Lifesciences Limited

ZYDUSLIFE

INE010B01027

Pharmaceuticals

Market Closed - 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%		-5.08%	-3.35%

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

Zydus Lifesciences Limited Announces Closure of USFDA Inspection at Zydus' Oncology Injectable Manufacturing Facility in SEZ1, Ahmedabad

Published on 11/13/2025 at 08:34 am EST

S&P Capital IQ

Zydus Lifesciences Limited

-1.88%

Zydus Lifesciences Limited announced that the USFDA conducted a Pre-Approval Inspection at SEZ Oncology Injectable manufacturing site in SEZ1, Ahmedabad, in relation to the new isolator injectable line. The inspection was conducted from 4th to 13th November, 2025 and concluded with two observations. There were no data integrity related observations.

The Company will closely work with the USFDA to address the observations expeditiously. This may kindly be considered as a disclosure pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Latest news about Zydus Lifesciences Limited

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
Nov. 27	Zydus Lifesciences Limited Receives Tentative Approval from USFDA for Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg	CI

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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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