Zydus Lifesciences Ltd

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Ammonium Lactate Cream, 12% (USRLD: Lac-Hydrin Cream', 12%). Ammonium lactate cream, 12% is a topical prescription medication indicated for the treatment of dry, scaly skin (xerosis) and an inherited dry skin condition called ichthyosis vulgaris. It is used to moisturise the skin by increasing hydration and, as an alpha-hydroxy acid, helps relieve itching, soften skin, and decrease skin scaling. Ammonium lactate cream will be manufactured at the group's topical manufacturing site at Changodar, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. Ammonium lactate cream had annual sales of USD 15 mn in the United States (IQVIA MAT December 2025). The group now has 430 approvals and has so far filed 505* ANDAs since the commencement of the filing process in FY 2003-04. Powered by Capital Market - Live

The company, along with its wholly owned subsidiary Zydus Pharmaceuticals USA, has entered into a settlement that concludes all ongoing patent litigations with Astellas concerning Myrbetriq and Mirabegron. Under the terms of the agreement, Zydus will pay Astellas an aggregate amount of $120 million. In addition, the company will pay a prepaid per-unit licensing fee on sales of its generic Mirabegron in the US from the date of the settlement until September 2027. Other terms of the agreement remain confidential. The settlement enables Zydus to continue marketing its generic Mirabegron product in the US market. In April 2025, Zydus had informed exchanges that the United States District Court for the District of Delaware had ruled in favour of Astellas on the validity of US Patent No. 10,842,780 related to a sustained-release formulation of mirabegron marketed as Myrbetriq. The court order had upheld the patent's validity, while issues relating to alleged infringement and damages were scheduled to be litigated at a consolidated jury trial in 2026. Zydus Lifesciences is a global life sciences company with operations across pharmaceuticals, consumer wellness, and medical technology. On a consolidated basis, its net profit rose 1.82% to Rs 1042.10 crore while net sales rose 32.34% to Rs 6780.40 crore in Q3 December 2025 over Q3 December 2024. Powered by Capital Market - Live

Zydus Lifesciences announced that the company and Zydus Pharmaceuticals USA, Inc., USA, a wholly owned subsidiary, (together referred to as Zydus), have entered into a Settlement Agreement with Astellas in relation to Astellas' Myrbetriq' (generic name: Mirabegron). Under the terms of the Settlement Agreement: 1. Zydus shall pay Astellas an aggregate amount of USD 120 million. 2. Zydus shall additionally pay a prepaid per unit licensing fee on units of Zydus' generic Mirabegron sold in the US from the date of Settlement Agreement till September 2027. This Settlement Agreement concludes all litigations between Astellas and the two companies relating to Myrbetriq' and Mirabegron and enables Zydus to continue marketing its generic Mirabegron in the US. Powered by Capital Market - Live

Net profit of Zydus Lifesciences rose 1.82% to Rs 1042.10 crore in the quarter ended December 2025 as against Rs 1023.50 crore during the previous quarter ended December 2024. Sales rose 32.34% to Rs 6780.40 crore in the quarter ended December 2025 as against Rs 5123.50 crore during the previous quarter ended December 2024. ParticularsQuarter EndedDec. 2025Dec. 2024% Var. Sales6780.405123.50 32 OPM %26.7927.08 - PBDT1797.901413.10 27 PBT1438.301184.10 21 NP1042.101023.50 2 Powered by Capital Market - Live

Zydus Lifesciences announced that the USFDA has granted Orphan Drug Designation (ODD) to Desidustat, a novel oral HIF-PHI, for the treatment of Sickle Cell Disease (SCD). 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. 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 has received tentative approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg (USRLD: Farxiga' Tablets, 5 mg and 10 mg). Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. Dapagliflozin tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad. Dapagliflozin tablets had annual sales of USD 10,486.9 mn in the United States (IQVIA MAT December 2025). Powered by Capital Market - Live

Zydus Lifesciences will hold a meeting of the Board of Directors of the Company on 9 February 2026.Powered by Capital Market - Live

Zydus Lifesciences announced that the USFDA conducted an inspection at the group's Unit ' 2 manufacturing plant at Ankleshwar, Gujarat. The inspection was conducted from 19th to 23rd January, 2026 and concluded with 3 observations. There were no data integrity related observations. The Company will closely work with the USFDA to address the observations expeditiously.Powered by Capital Market - Live

Zydus Lifesciences has launched the world's first biosimilar of Nivolumab in India under the brand name Tishtha', reinforcing the company's growing capability in advanced biologics and Immuno-Oncology. Tishtha' will be available in 100 mg and 40 mg dosages priced at Rs 28,950 and Rs 13,950 respectively. The prices are approximately 1/4th of the reference drug. This will improve affordability and reduce the overall treatment burden for patients. The two strength portfolio enables oncologists to optimise dosing and minimise wastage - a key driver of treatment economics in immunotherapy. Powered by Capital Market - Live

The product is available in 100 mg and 40 mg strengths, priced at Rs 28,950 and Rs 13,950 respectively. The company said the prices are approximately one-fourth of the reference drug. According to the company, the lower pricing is expected to improve affordability and reduce the overall cost of immunotherapy, with potential benefits for more than 5 lakh patients. The availability of two dosage strengths is intended to help clinicians optimise dosing and minimise drug wastage, which is a key cost factor in immuno-oncology treatments. Zydus stated that Tishtha has been developed and manufactured in India, with an emphasis on ensuring consistent and long-term availability for patients who require therapy over multiple treatment cycles. The company highlighted affordability, consistency of supply, and reach as critical factors influencing access to modern cancer therapies. Zydus Lifesciences is a global life sciences company with operations across pharmaceuticals, consumer wellness, and medical technology. It posted a 38.12% YoY rise in consolidated net profit to Rs 1,258.6 crore in Q2 FY26, while revenue grew 18.07% to Rs 6,037.9 crore. Powered by Capital Market - Live