Zydus Lifesciences Ltd

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

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Olaparib Tablets, 100 mg and 150 mg (USRLD: Lynparza Tablets, 100 mg and 150 mg). Olaparib is indicated for treatment of certain types of ovarian, breast, pancreatic, and prostate cancers in patients who have specific genetic mutations (specifically in the BRCA gene or other homologous recombination repair [HRR] genes). Olaparib tablets will be produced at Zydus Lifesciences Ltd, SEZ. Olaparib tablets had annual sales of USD 1,379.4 mn in the United States (IQVIA MAT Sept-2025). Powered by Capital Market - Live

Net profit of Zydus Lifesciences rose 38.13% to Rs 1258.60 crore in the quarter ended September 2025 as against Rs 911.20 crore during the previous quarter ended September 2024. Sales rose 18.08% to Rs 6037.90 crore in the quarter ended September 2025 as against Rs 5113.60 crore during the previous quarter ended September 2024. ParticularsQuarter EndedSep. 2025Sep. 2024% Var. Sales6037.905113.60 18 OPM %33.3928.58 - PBDT2023.501504.50 34 PBT1721.601270.90 35 NP1258.60911.20 38 Powered by Capital Market - Live

Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26. Profit before tax (PBT) jumped 32.77% to Rs 1,687.4 crore in Q2 FY26, compared with Rs 1270.89 crore in Q2 FY25. EBITDA for the quarter was Rs 2,015.80 crore, up 37.93% YoY. EBITDA margin for the quarter stood at 32.9% as against 27.9% in Q2 FY25. The India Formulations business reported revenues of Rs 1,593.1 crore in Q2 FY26, an 8% year-on-year increase, accounting for 26% of consolidated revenues. The branded formulations segment grew 9% YoY, outpacing market growth, supported by strong traction in innovation products and pillar brands. During the quarter, the company launched VaxiFlu', India's first trivalent influenza vaccine, in line with WHO's global recommendations. The business outperformed the Indian Pharmaceutical Market (IPM) in key therapies such as cardiology, gynecology, and the super specialty segment of oncology, where it continued to maintain its leadership position. The chronic portfolio share rose steadily to 44.5%, an improvement of 500 basis points over the past three years, according to IQVIA MAT September 2025 data. The Consumer Wellness business reported revenues of Rs 637.4 crore in Q2 FY26, a 31% year-on-year increase, contributing 11% of total revenues. During the quarter, the company completed the acquisition of UK-based Comfort Click Limited (CCL), its first international acquisition in the wellness segment. The move is expected to significantly enhance the company's global presence across key markets in the UK, EU, and the US. CCL is one of the fastest-growing digital consumer healthcare platforms in the high-growth Vitamins, Minerals, and Supplements (VMS) space, generating most of its revenues through e-commerce and direct-to-consumer (D2C) channels. Its portfolio includes three brands ' WeightWorld', offering plant-based supplements, vitamins, minerals, and sports nutrition for adults; Maxmedix', a specialty VMS gummy brand catering to pediatric nutritional needs; and Animigo, a natural pet VMS brand offering a range of pet care products. The US Formulations business reported revenues of Rs 2,743.7 crore in Q2 FY26, reflecting a 14% year-on-year growth but a 14% decline quarter-on-quarter, contributing 45% of consolidated revenues. In constant currency terms, revenues stood at US$ 313 million. During the quarter, the company launched 7 new products, filed 6 ANDAs and received approval for 4 ANDAs, including 1 tentative approval. On the specialty front, in October 2025, the company launched Beizray (albumin solubilized docetaxel injection), further strengthening its 505(b)(2) portfolio. Additionally, the company received its first Notice of Compliance (NOC) in Canada with approval from Health Canada for Varenicline tablets 0.5 mg & 1 mg, bringing the total NOCs received so far to 3, including 2 approvals in October 2025. The International Markets Formulations business reported revenues of Rs 751.3 crore in Q2 FY26, up 39% YoY, contributing 12% of consolidated revenues, driven by broad-based growth across emerging markets and Europe. The Medtech business posted revenues of Rs 153.2 crore, accounting for 3% of consolidated revenues, following the completion of 100% acquisition of Amplitude Surgical, after acquiring the remaining 14.4% stake in October 2025. The API business registered revenues of Rs 147.2 crore, up 23% YoY, representing 2% of consolidated revenues. Meanwhile, the Alliances & Others segment reported revenues of Rs 12 crore, down 85% YoY, contributing 0.2% of consolidated revenues. Dr. Sharvil Patel, MD, Zydus Lifesciences, 'Our strong performance this quarter reaffirms the power of our diversified business model and our execution capabilities across geographies and verticals. We delivered robust revenue growth and industry-leading profitability, aided by consistent outperformance in our US and India formulations businesses, sustained high growth in International Markets as well as strategic acquisitions in Wellness and MedTech. These results reflect our commitment to sustainable growth and global expansion, anchored in quality, compliance, and patient-centric innovation.' 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. Shares of Zydus Lifesciences declined 2.12% to Rs 952.20 on the BSE. Powered by Capital Market - Live

Zydus Lifesciences today announced that the USFDA has granted Orphan Drug Designation (ODD) to Desidustat, a novel oral HIF-PHI, for the treatment of beta thalassemia. The USFDA's Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited, said, 'This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop Desidustat to address beta-thalassemia.' Beta thalassaemia patients have low levels of haemoglobin, which results in a lack of oxygen in many parts of the body, leading to weakness, fatigue and more serious complications. Treatment for people with beta thalassaemia often requires lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. Desidustat is a hypoxia inducible factor (HIF)-prolyl hydroxylase inhibitor (PHI) and has the potential to increase haemoglobin and red blood cell counts. Research in beta-thalassaemic mice showed that desidustat treatment led to an increase in haemoglobin and red blood cell (RBC) levels1. Orphan drug designation by the USFDA for Desidustat, provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and a potential seven-year marketing exclusivity upon the USFDA approval. Powered by Capital Market - Live

Zydus Lifesciences announced that the USFDA conducted an inspection at the group's manufacturing plant located SEZ - II, Ahmedabad, from 11th to 14th August 2025. The inspection was a Pre-Approval Inspection (PAI). The USFDA has concluded this inspection as closed. The inspection concluded with NIL observations. The EIR has classified the facility as No Action Indicated (NAI).Powered by Capital Market - Live

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Budesonide delayed-release capsules, 4 mg (USRLD: Tarpeyo Capsules, 4 mg). Budesonide is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children 8 years of age and older. Budesonide capsules will be produced at is Zydus Pharmaceuticals Ltd, SEZ-II. Powered by Capital Market - Live

The inspection at the facility was conducted by the USFDA from 4 August to 13 August 2025. Following the review, the agency has classified the facility as Voluntary Action Indicated (VAI), and the inspection has been concluded as closed by the USFDA. The EIR has classified the facility as Voluntary Action Indicated (VAI). The USFDA has concluded this inspection as closed. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company's consolidated net profit rose 3.3% to Rs 1,466.80 crore on a 7% rise in revenue from operations to Rs 6,467 crore in Q1 FY26 over Q1 FY25. The counter rose 0.04% to Rs 1,001.80 on the BSE. Powered by Capital Market - Live

Zydus Lifesciences will hold a meeting of the Board of Directors of the Company on 6 November 2025.Powered by Capital Market - Live