Zydus Lifesciences' innovative drug Desidustat has received approval from China's NMPA for treating anaemia in Chronic Kidney Disease (CKD) patients. Licensed to China Medical System Holdings (CMS) in 2020, the drug addresses a significant unmet need for over 120 million CKD patients in China. Desidustat is an oral HIF-PHI, offering better compliance than traditional treatments, and has already treated over 100,000 patients in India since its 2022 launch. This approval follows successful Phase III clinical trials that met primary efficacy endpoints for hemoglobin maintenance.

Zydus Lifesciences has received final USFDA approval for Cevimeline Hydrochloride Capsules 30mg, used to treat dry mouth associated with Sjögren’s syndrome. The product will be manufactured at the company's SEZ-II facility in Ahmedabad and targets a market with annual sales of USD 26.9 million as of January 2026. This approval brings the group's total USFDA approvals to 436, reflecting a strong track record in the US generic market. The company has filed a total of 505 ANDAs since the commencement of its filing process in FY 2003-04.

Zydus Lifesciences has expanded its companion diagnostics portfolio with the launch of Diasens and GlucoLive, next-generation AI-powered Continuous Glucose Monitoring (CGM) devices. These devices target India's massive diabetic population of 101 million and 136 million pre-diabetics by offering real-time data streaming every three minutes. The company has partnered with TatvaCare to integrate these devices with the GoodFlip app, providing a comprehensive AI-driven care ecosystem. This launch addresses a critical gap in the Indian market where most glucose monitoring is currently episodic or requires manual scanning.

Zydus Lifesciences has received final USFDA approvals for Ivermectin Tablets (3 mg) and Dapsone Tablets (25 mg and 100 mg). Ivermectin is an anti-parasitic medication with annual US sales of approximately $14.8 million, while Dapsone is used for leprosy and skin conditions with annual US sales of $8.4 million. Both products will be manufactured at the company's Ahmedabad facilities and distributed by Viona Pharmaceuticals Inc. This milestone brings the company's total USFDA approvals to 434, reinforcing its strong pipeline in the US generics market.

Zydus Lifesciences has successfully completed the pivotal Dahlia pharmacokinetic study for FYB206, a biosimilar to the blockbuster oncology drug Keytruda. The study demonstrated bioequivalence, clearing the path for a near-term Biologics License Application filing with the USFDA for the US and Canadian markets. Keytruda recorded massive global sales of $31.6 billion in 2025, representing a significant market opportunity for Zydus as a potential first-wave filer. This development marks the company's strategic entry into the complex and high-value North American immuno-oncology space.

Zydus Lifesciences has successfully completed a USFDA Pre-Approval Inspection (PAI) at its Unit 9 injectable facility in Ahmedabad. The inspection, conducted between February 16 and February 19, 2026, focused on Injectable Medical Devices. Crucially, the audit concluded with zero observations, indicating full compliance with US regulatory standards. This successful outcome paves the way for future product approvals from this specific site, strengthening the company's US export pipeline.

Zydus Lifesciences has launched ANYRA™, the first indigenously developed biosimilar of Aflibercept 2 mg in India, targeting critical ophthalmic conditions. The product addresses a massive domestic market including over 100 million diabetics and approximately 7-8 million individuals suffering from Diabetic Retinopathy. This launch expands Zydus' biosimilar portfolio to over 13 molecules, all developed and manufactured entirely in India. By offering an affordable alternative for chronic retinal diseases requiring repeated injections, Zydus is positioned to capture significant share in the anti-VEGF therapy market.

Zydus Lifesciences has received final USFDA approval for Bosentan tablets for oral suspension, 32 mg, targeting Pulmonary Arterial Hypertension (PAH) in pediatric patients. The drug is a generic version of Tracleer and will be manufactured at the company's SEZ facility in Ahmedabad. According to IQVIA MAT December 2025 data, the annual US market for this specific dosage is approximately USD 9.3 million. This approval brings the group's total USFDA approvals to 432, reinforcing its steady growth in the US generic market.

Zydus Lifesciences has launched PEPAIR™, a first-of-its-kind affordable, drug-free handheld device for respiratory health in India. Priced at Rs. 990, the device targets over 90 lakh patients suffering from chronic conditions like COPD, Asthma, and Bronchiectasis. The product was developed in collaboration with AeroDel Technology Innovations to address the affordability gap in airway clearance therapy. This launch strengthens Zydus's dominant position in the Indian respiratory market, complementing its existing portfolio of oral and inhalation therapies.

Zydus Lifesciences reported a strong Q3 FY26 with consolidated revenues growing 30% YoY to ₹68.6 billion, driven by robust performance across US, India, and international markets. The EBITDA margin remained healthy at 26.5%, while adjusted net profit rose 9% to ₹11.1 billion. Key growth drivers include the successful consolidation of Comfort Click and Amplitude Surgical, alongside a 14% growth in the domestic branded formulation business. The company is pivoting towards specialty products and biosimilars, with the upcoming US filing of Saroglitazar for PBC being a major milestone.

Zydus Lifesciences has secured final USFDA approval for Ammonium Lactate Cream, 12%, a generic version of Lac-Hydrin Cream used for treating dry skin conditions. The product will be manufactured at the company's topical manufacturing facility in Changodar, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. According to IQVIA MAT December 2025 data, the annual US market for this cream is approximately USD 15 million. This approval brings the company's total USFDA approvals to 430, reflecting a steady expansion of its US generic portfolio.

Zydus Lifesciences reported a robust Q3 FY26 with consolidated revenue growing 30.3% YoY to Rs. 68,645 mn, driven by strong performance in North America and the consolidation of recent acquisitions. Adjusted Net Profit rose 8.5% YoY to Rs. 11,109 mn, while EBITDA margins improved by 20 bps to 26.5%. The Consumer Wellness segment saw a massive 113% growth due to the Comfort Click Limited consolidation, and the MedTech business contributed Rs. 2,996 mn. The company maintains a healthy balance sheet with a Net Debt to Equity ratio of 0.11x.

Zydus Lifesciences delivered a robust Q3 FY26 performance with total revenue growing 30% YoY to Rs. 68,645 mn, driven by strong growth in North America and the consolidation of the Comfort Click acquisition. EBITDA margins remained healthy at 26.5%, while adjusted net profit grew 9% YoY to Rs. 11,109 mn. The company's India formulations business outpaced market growth, particularly in chronic therapies, and the innovation pipeline remains on track with a planned NDA filing for Saroglitazar in the US this quarter.

Zydus Lifesciences has been granted Orphan Drug Designation (ODD) by the USFDA for Desidustat, a novel oral treatment for Sickle Cell Disease (SCD). This designation offers significant benefits, including a potential seven-year marketing exclusivity period in the U.S. upon final approval. The company has already completed a Phase II proof-of-concept study for this indication, with results expected to be published in a medical journal soon. This milestone strengthens Zydus's position in the rare disease segment and highlights the potential of its New Chemical Entity (NCE) pipeline.

Zydus Lifesciences has secured tentative approval from the USFDA for Dapagliflozin Tablets (5 mg and 10 mg), a generic version of Farxiga used for type 2 diabetes. This approval targets a significant market, as Dapagliflozin had annual US sales of approximately $10,486.9 million as of December 2025. The product will be manufactured at the company's Ahmedabad SEZ facility, strengthening its US portfolio which now stands at 430 approvals. While the approval is tentative, it positions Zydus to capture a share of a high-value therapeutic segment upon final clearance.

Zydus Lifesciences has launched Tishtha™, the world’s first biosimilar of Nivolumab, in India for treating multiple cancers. The drug is priced at approximately 1/4th the cost of the reference drug, with the 100 mg vial at ₹28,950 and 40 mg at ₹13,950. This launch targets a massive addressable market of over 5 lakh patients in India. By being the first to market with this biosimilar, Zydus is positioned to capture significant market share in the high-growth immuno-oncology segment.

Zydus Lifesciences has successfully closed the acquisition of two US-based biologics manufacturing facilities in California and a 5.9% equity stake in Agenus Inc. (2,133,333 shares). The company has launched Zylidac Bio LLC to operate these assets, positioning itself as a strategic CDMO partner in the U.S. following the enactment of the BIOSECURE Act. Furthermore, Zydus secured exclusive licensing rights for Agenus' Phase 3 immuno-oncology candidates, Botensilimab and Balstilimab, for the India and Sri Lanka markets. This comprehensive deal strengthens Zydus' global biologics footprint and provides a localized U.S. supply chain for its expanding biosimilar portfolio.