Zydus Lifesciences Ltd

Zydus Lifesciences has received the Establishment Inspection Report (EIR) from the USFDA for a GMP follow-up inspection conducted at its injectable facility located at Jarod, Vadodara from 25 August to 05 September 2025 and classifying the facility as Voluntary Action Indicated (VAI). This inspection was conducted following the Warning Letter issued on 29 August 2024 by the USFDA. Powered by Capital Market - Live

The approved ANDA is a generic version of the US reference listed drug Glyxambi Tablets. Empagliflozin and Linagliptin Tablets, in a combination, are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate. Empagliflozin and Linagliptin Tablets will be produced at the group's formulation manufacturing facility at SEZ, Ahmedabad. Empagliflozin and Linagliptin Tablets had annual sales of USD 215.8 mn in the United States (IQVIA MAT Sept-2025). The group now has 428 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04. The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. Zydus Lifesciences reported a 38.12% jump in consolidated net profit to Rs 1,258.60 crore in Q2 FY26, compared with Rs 911.2 crore posted in Q2 FY25. Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26. The scrip rose 0.54% to currently trade at Rs 942.35 on the BSE. Powered by Capital Market - Live

Under the terms of the agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization in the US. The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and is designed to reduce dosing errors and enhance compliance among healthcare professionals. The novel product targets a significant commercial opportunity in the US market, with an estimated total addressable market (TAM) of 6.2 million units, according to IQVIA MAT September 2025 data. Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, said, 'We are delighted to collaborate with RK Pharma to bring this innovative product to patients in the US. This partnership reinforces our commitment to delivering high-quality, affordable medicines and improving patient care.' Dr. Ravishanker Kovi, Founder and Executive Chairman of RK Pharma, stated, 'This novel 505(b)(2) product of supportive oncology treatment highlights RK Pharma's testament to advanced capabilities in formulation and manufacturing, particularly in specialized areas like sterile injectables and complex generics. Our collaboration with Zydus, a company with robust regulatory expertise and a powerful commercial footprint, ensures that this important therapeutic option reaches patients efficiently, reinforcing our shared mission to improve access to high-quality healthcare in the USA.' The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. Zydus Lifesciences reported a 38.12% jump in consolidated net profit to Rs 1,258.60 crore in Q2 FY26, compared with Rs 911.2 crore posted in Q2 FY25. Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26. Powered by Capital Market - Live

Zydus Lifesciences has entered into an exclusive licensing and commercialization agreement with RK Pharma Inc of the US for a novel sterile injectable 505(b)(2) oncology supportive care product for the US market. Under the terms of this agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US. The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and will provide a formulation that is intended to provide reduced dosing error and enhanced compliance of healthcare professionals.Powered by Capital Market - Live

Zydus Lifesciences Ltd gained for a third straight session today. The stock is quoting at Rs 942.5, up 1.51% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 1.08% on the day, quoting at 26165.55. The Sensex is at 85506.55, up 1.09%. Zydus Lifesciences Ltd has slipped around 7.04% in last one month. Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has slipped around 1.96% in last one month and is currently quoting at 22590.95, up 0.7% on the day. The volume in the stock stood at 5.83 lakh shares today, compared to the daily average of 10.11 lakh shares in last one month. The benchmark December futures contract for the stock is quoting at Rs 949.35, up 1.75% on the day. Zydus Lifesciences Ltd is down 0.89% in last one year as compared to a 7.79% spurt in NIFTY and a 4.21% spurt in the Nifty Pharma index.The PE of the stock is 19.34 based on TTM earnings ending September 25.Powered by Capital Market - Live

Stocks To Watch: The listing of Excelsoft Technologies is scheduled for today. The issue was subscribed 43.19 times. The issue opened on 19 November 2025 and it closed on 21 November 2025. The price band of the IPO was fixed between Rs 114 and 120 per share. NCC has received a letter of acceptance from Public Works (Health & Education) Department, Assam for expansion and modernization of Gauhati Medical College & Hospital, Guwahati, Assam. The said contract valued at Rs 2,062.71 crore. Nelco has received additional authorization for Unified License (Virtual Network Operator) license from Department of Telecommunications, Ministry of Communications, Government of India. It will allow Nelco to sell VSAT services of other UL- GMPCS licensees. Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Verapamil Hydrochloride extended-release tablets USP, 120 mg, 180 mg and 240 mg. Jayant Infratech has received letter of acceptance from Konkan Railway Corporation for an engineering, procurement, and construction (EPC) contract. The total value of the contract is Rs 161,68,31,043.98 (inclusive of all duties and taxes). Refex Industries has incorporated a wholly owned subsidiary, Venwind Refex Projects (VRPL) to engage in generating, transmitting, distributing, and trading power from all energy sources and in developing and operating related facilities. United Breweries announced the launch of beer, Heineken Silver in New Delhi. The beer is now available in New Delhi and priced at Rs 155 for a 330ml bottle, Rs 180 for a 500ml can, and Rs 305 for a 650ml bottle.Powered by Capital Market - Live

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Verapamil Hydrochloride Extended-Release Tablets USP, 120 mg, 180 mg and 240 mg (USRLD: Calan SR Extended-Release Tablets, 120 mg, 180 mg and 240 mg). Verapamil Hydrochloride Extended-Release Tablets (120 mg, 180 mg, and 240 mg) are used to lower high blood pressure, which helps reduce the risk of serious heart problems like strokes and heart attacks. Verapamil Hydrochloride Extended-Release Tablets will be produced at Zydus Lifesciences Ltd, Baddi, Himachal Pradesh. Verapamil Hydrochloride Extended-Release Tablets had annual sales of USD 24.5 mn in the United States (IQVIA MAT Sept-2025). Powered by Capital Market - Live

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial (USRLD: Lupron Injection', 1 mg/0.2 mL). Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer. Leuprolide Acetate injections will be manufactured at the Company's oncology injectable manufacturing facility at SEZ1, Ahmedabad ('ALIDAC'). Leuprolide Acetate injection had annual sales of USD 69 mn in the United States (IQVIA MAT Sept 2025). Powered by Capital Market - Live

Zydus Lifesciences has received approval from the National Medical Products Administration (NMPA), China for Venlafaxine Extended-Release (ER) Capsules, 75 mg and 150 mg. Venlafaxine ER Capsules are indicated for the treatment of Major Depressive Disorder (MDD), Generalised Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD). They help restore the balance of serotonin and norepinephrine in the brain to improve mood and reduce anxiety. Venlafaxine ER Capsules will be produced at Zydus' manufacturing facility at Moraiya, Ahmedabad. This is the first approval that the Group has received from NMPA in China. Powered by Capital Market - Live

Olaparib is indicated for the treatment of ovarian, breast, pancreatic, and prostate cancers in patients with specific genetic mutations, particularly those in the BRCA gene or other homologous recombination repair (HRR) genes. The drug will be manufactured at Zydus Lifesciences' SEZ facility. The approved product is bioequivalent to Lynparza Tablets (100 mg and 150 mg), which recorded annual sales of $1,379.4 million in the United States, according to IQVIA MAT data for September 2025. With this approval, Zydus Lifesciences' total tally now stands at 426 approvals, from a cumulative 487 ANDA filings since the company began the process in FY 2003'04. The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. Zydus Lifesciences reported 38.12% jump in consolidated net profit to Rs 1,258.60 crore in Q2 FY26, compared with Rs 911.2 crore posted in Q2 FY25. Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26. The counter shed 0.03% to Rs 943.50 on the BSE. Powered by Capital Market - Live