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Latest news about Zydus Life Science

Zydus Lifesciences Secures Top-Tier USFDA Approval for API Facility 3 days ago

Zydus Lifesciences has received an Establishment Inspection Report (EIR) from the USFDA for its API manufacturing facility in Ankleshwar. The inspection was classified as 'No Action Indicated' (NAI), the best possible outcome, validating the facility's high-quality standards and regulatory compliance. This achievement strengthens Zydus's market position, particularly for U.S. exports, and is likely to boost investor confidence.

Zydus Lifesciences Secures FDA Clearance for Gujarat API Facility, Reports Mixed Q4 Results 3 days ago

Zydus Lifesciences Secures Clean FDA Inspection for Ankleshwar API Plant 3 days ago

Zydus Lifesciences Secures FDA Approval for Largest API Facility 4 days ago

Zydus Lifesciences Acquires Agenus' US Facilities for $75 Million, Enters Biologics CDMO Market Jun 03, 2025

More news about Zydus Life Science

03Jun 25

Zydus Lifesciences' US Subsidiary to Acquire 5.9% Stake in Agenus for $16 Million

Zydus Lifesciences' US subsidiary, Zynext Ventures USA LLC, is acquiring a 5.9% stake in Agenus Inc., a biotechnology company specializing in cancer immunotherapies. The deal involves purchasing 2,133,333 shares at $7.50 per share, totaling $16 million. This strategic investment is expected to complete within 60 days, subject to regulatory approvals. The move strengthens Zydus's position in the cancer immunotherapy field and provides access to Agenus's innovative research in next-generation cancer treatments.

03Jun 25

Zydus Lifesciences Expands U.S. Presence with $75 Million Biologics Facility Acquisition

Zydus Lifesciences has agreed to acquire two biologics manufacturing facilities from Agenus West LLC and Agenus Inc. in the United States. The deal involves an upfront payment of $75 million, with potential additional payments of up to $50 million over three years. This acquisition aims to strengthen Zydus's presence in the U.S. biologics market, enhance its manufacturing capabilities, and potentially accelerate its biologics development pipeline.

02Jun 25

Zydus Lifesciences Secures Tentative FDA Approval for Irritable Bowel Syndrome Drug

Zydus Lifesciences has received tentative approval from the U.S. FDA for Rifaximin tablets (550 mg), used to treat irritable bowel syndrome with diarrhea in adults. The tablets will be manufactured at the company's Ahmedabad facility. The drug had annual U.S. sales of ₹22,218.36 crore ($2,672.90 million), indicating significant market potential.

02Jun 25

Zydus Life Secures Tentative USFDA Approval for Rifaximin Tablets

Zydus Life has received tentative approval from the USFDA for Rifaximin Tablets, 550 mg. The product had annual sales of $2,673.00 million in the United States. This approval signifies that the drug has met quality, safety, and efficacy standards, but final approval and market launch may be subject to patent expirations or legal challenges. The development is expected to strengthen Zydus Life's position in the U.S. pharmaceutical market, particularly in the gastrointestinal therapeutic area.

28May 25

Zydus Lifesciences' ALS Drug Usnoflast Receives FDA Fast Track Designation

Zydus Lifesciences' novel oral NLRP3 inhibitor, Usnoflast, has been granted Fast Track designation by the U.S. FDA for the treatment of Amyotrophic Lateral Sclerosis (ALS). The drug has already completed Phase 2(a) trials in India and received approval for Phase 2(b) trials in the United States. Usnoflast previously received Orphan Drug Designation from the FDA. This development could potentially accelerate the drug's review process, bringing a new treatment option to ALS patients sooner.

28May 25

Zydus Lifesciences Secures FDA Fast Track Designation for Novel ALS Treatment

Zydus Lifesciences has received Fast Track Designation from the U.S. FDA for Usnoflast, an oral NLRP3 inhibitor targeting Amyotrophic Lateral Sclerosis (ALS) treatment. This designation aims to expedite the development and review process for drugs addressing serious conditions with unmet medical needs. Usnoflast's approach focuses on reducing inflammation associated with ALS progression by inhibiting NLRP3, a key component of the inflammasome. While this designation doesn't guarantee approval, it represents a significant milestone in Zydus's neuroscience R&D and offers hope for potential new ALS treatment options.

27May 25

Zydus Life Sets Ambitious Target: Double-Digit Revenue Growth by FY26

Zydus Life has announced its goal to achieve double-digit revenue growth by fiscal year 2026. The company's growth strategy focuses on strong performance in the Indian market and expansion in international markets. This ambitious target reflects Zydus Life's confidence in its business model and growth prospects in the competitive pharmaceutical industry.

23May 25

Zydus Lifesciences Secures USFDA Approval for Isotretinoin Capsules Across Multiple Strengths

Zydus Lifesciences has received final approval from the USFDA for Isotretinoin Capsules USP in six strengths: 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg. The approved drug recorded annual sales of $115.40 million in the United States as of March 2025. This approval enhances Zydus' product portfolio and market presence in the U.S. pharmaceutical industry, particularly in dermatology therapeutics.

21May 25

Zydus Lifesciences Reports Strong Q4 Results, Projects Sustainable Growth

Zydus Lifesciences announced impressive Q4 financial results with revenue up 18% YoY to Rs 65,279 million and EBITDA up 30.4% to Rs 21,255 million. The company projects EBITDA margins to exceed 26% in the future and anticipates its base business to sustain $1 billion in revenue. Management expects better-than-estimated franchise performance and single-digit growth in the US market. The company's strong Q4 performance, particularly in US generics, supports these positive projections.

20May 25

Zydus Life's India Branded Formulations Business Outpaces Market Growth

Zydus Life Sciences Limited has reported significant growth in its India Branded Formulations business, outperforming the overall market growth rate. The company achieved double-digit growth in this segment, indicating a strengthening position in the domestic pharmaceutical market. This success suggests effective strategies in product development, marketing, and distribution, potentially leading to increased revenue, improved market position, and enhanced brand strength.

20May 25

Zydus Lifesciences Reports Strong Q4 Results with 24% Growth in US Formulation Sales

Zydus Lifesciences announced Q4 results with revenue up 18% to ₹6,528.00 crore and EBITDA up 30% to ₹2,126.00 crore. US formulation sales grew 24% YoY to $363 million. Net profit slightly decreased by 1% to ₹1,171.00 crore due to a one-time loss of ₹220.00 crore. The board recommended a final dividend of ₹11.00 per share.

14May 25

Zydus Lifesciences' Ambernath API Facility Receives Positive Regulatory Inspection Report

Zydus Lifesciences has received an Establishment Inspection Report (EIR) for its Active Pharmaceutical Ingredient (API) manufacturing facility in Ambernath. This signifies successful passage of a regulatory inspection, allowing operational continuity and demonstrating the company's commitment to quality standards. The EIR is expected to boost market confidence and potentially provide a competitive advantage in the pharmaceutical industry.

09May 25

Zydus Life Secures FDA Approval for Generic Copaxone, Targeting $719 Million Market

Zydus Life has received FDA approval for its generic version of Copaxone (Glatiramer Acetate Injection) in both 20 mg/mL and 40 mg/mL strengths. This approval allows Zydus to enter the U.S. multiple sclerosis treatment market, where the original drug Copaxone has annual sales of $719 million. The approval expands Zydus Life's product portfolio and market presence in the U.S., potentially becoming a significant revenue driver for the company.

30Apr 25

Zydus Lifesciences Secures FDA Approval for Cholesterol-Lowering Drug

Zydus Lifesciences has received final FDA approval for Niacin Extended-Release Tablets USP in 500 mg, 750 mg, and 1,000 mg strengths. The drug, a generic version of Niaspan®, treats hyperlipidaemia and mixed dyslipidaemia. Annual US sales for this medication were $5.50 million as of February 2025. Zydus will manufacture the tablets at its Moraiya facility in Ahmedabad. The company now has 425 FDA approvals and 492 ANDAs filed since 2003-04.

28Apr 25

Zydus Lifesciences Expands Global Footprint with Amplitude Surgical Acquisition, Faces FDA Scrutiny

Zydus Lifesciences has agreed to acquire an 85.60% stake in French medical device company Amplitude Surgical SA, with 75.40% of shares to be purchased at €6.25 per share. This move strengthens Zydus' presence in the European medical devices market. Meanwhile, the USFDA has issued 6 observations following an inspection of Zydus' API manufacturing facility in Dabhasa, Gujarat. None of the observations were related to data integrity issues.

26Apr 25

Zydus Lifesciences Receives Six Observations in USFDA Inspection of Gujarat API Unit

Zydus Lifesciences' API manufacturing facility in Dabhasa, Gujarat underwent a USFDA inspection from April 21-25, 2025. The inspection resulted in six observations, none related to data integrity issues. The company is confident in addressing these observations promptly, maintaining its ability to supply APIs to the U.S. market.

26Apr 25

Zydus Lifesciences' API Facility Inspection Concludes with 6 USFDA Observations

Zydus Lifesciences' API manufacturing facility in Dabhasa, Gujarat, underwent a USFDA inspection from April 21-25, 2025. The inspection resulted in six observations, none related to data integrity. The company expressed confidence in addressing these observations promptly, demonstrating its commitment to regulatory compliance and quality standards in pharmaceutical manufacturing.

25Apr 25

Zydus Lifesciences Finalizes Agreement to Acquire 85.6% Stake in Amplitude Surgical

Zydus Lifesciences has signed an agreement to acquire 85.6% of Amplitude Surgical, a French orthopedic medical devices company, for €6.25 per share. The deal, expected to close by Q3 2025, will expand Zydus's presence in the European orthopedic market. Amplitude Surgical, with €106 million in sales and operations in over 30 countries, specializes in lower limb orthopedics.

21Apr 25

Zydus Lifesciences' Unit Secures Global Licensing Deal for Innovative Heart Valve Technology

Zydus Lifesciences' subsidiary, Zydus Medtech, has entered a global licensing agreement with Brazil's Braile Biomedica for Transcatheter Aortic Valve Implantation (TAVI) technology. The deal grants Zydus commercialization rights in India, Europe, and select markets. TAVI is a minimally invasive procedure for replacing diseased aortic valves without open-heart surgery. This strategic move aims to expand Zydus' market presence in cardiovascular medical devices, potentially opening new revenue streams and enhancing its healthcare product portfolio.

18Apr 25

Zydus Medtech Expands Global Reach with Innovative TAVI Technology Licensing Deal

Zydus Medtech, a subsidiary of Zydus Lifesciences, has secured exclusive rights to market Transcatheter Aortic Valve Implantation (TAVI) technology from Brazil's Braile Biomedica in India, Europe, and select markets. The global TAVI market, valued at over $6 billion, presents significant growth opportunities. The partnership aims to launch new innovations over the next three years, supported by clinical research. Additionally, Zydus is set to acquire over 90% of Amplitude Surgical SA and is evaluating a U.S. court order regarding a patent held by Astellas Pharma Inc.

17Apr 25

Zydus Lifesciences Faces Setback in US Patent Dispute with Astellas Pharma

Zydus Lifesciences has encountered a legal challenge in its attempt to introduce a generic version of mirabegron in the US market. The US District Court for Delaware ruled in favor of Astellas Pharma, upholding their patent for the sustained release formulation of mirabegron (Myrbetriq®). A consolidated jury trial is scheduled for 2026 to address potential patent infringement, damages, and additional invalidity theories. Zydus reports no immediate material financial impact but is evaluating the court order and exploring legal remedies.

17Apr 25

Zydus Life Expands Global Footprint: Tender Offer for Amplitude Surgical SA Shares and Strategic Investments

Zydus Lifesciences Limited plans to participate in a tender offer for shares of Amplitude Surgical SA, a French orthopedic device company. This move indicates Zydus's intention to expand globally and potentially strengthen its position in the orthopedic medical devices market. Additionally, Zydus's venture capital arm has invested in Feldan Therapeutics, a Canadian company developing intracellular delivery treatments. The company also faces a legal challenge in the US regarding a patent held by Astellas Pharma Inc. for a mirabegron formulation.

16Apr 25

Zydus Lifesciences Faces Setback in US Patent Litigation for Mirabegron Formulation

Zydus Lifesciences received an unfavorable ruling from the US District Court for the District of Delaware on April 15, 2025, regarding a patent litigation case for a sustained-release formulation of mirabegron. The court ruled in favor of Astellas Pharma Inc., USA, the innovator company marketing the drug under the brand name Myrbetriq®. Zydus is evaluating the impact of this order on its operations and considering legal remedies. The company's stock price was affected by this news, and Zydus emphasized its commitment to timely disclosure of the information to stock exchanges.

16Apr 25

Zydus Lifesciences Faces Drug Withdrawal Order and Financial Penalties

Zydus Lifesciences and Lupin have been ordered to withdraw an unspecified drug from the market and face financial penalties. This regulatory action suggests potential safety or compliance issues with the pharmaceutical product. The incident highlights the strict regulatory environment in the pharmaceutical sector and may impact Zydus Lifesciences' product portfolio and market position. The company has not yet issued an official statement regarding this development.

15Apr 25

Zydus Lifesciences Expands Global Footprint with €256.80 Million Acquisition and Gains FDA Approval

Zydus Lifesciences has announced plans to acquire an 85.6% stake in Amplitude Surgical SA, a French orthopedic company, for €256.80 million. This move expands Zydus's presence in the European medical devices market. Additionally, Zydus received FDA approval to manufacture Deflazacort tablets for treating Duchenne muscular dystrophy, strengthening its position in the U.S. pharmaceutical sector.

11Apr 25

Zydus Lifesciences Secures FDA Approval for Duchenne Muscular Dystrophy Treatment, Expands European Presence

Zydus Lifesciences received FDA approval for Jaythari® (Deflazacort) Tablets to treat Duchenne muscular dystrophy. The company also incorporated a new subsidiary, Zydus MedTech (France) SAS, as part of its European expansion strategy. Zydus plans to acquire an 85.6% stake in Amplitude Surgical SA for €256.80 million, with intentions to fully acquire and delist the company.

11Apr 25

Zydus Lifesciences Establishes French Subsidiary for €256.8 Million Amplitude Surgical Acquisition

Zydus Lifesciences has incorporated a new subsidiary, Zydus MedTech (France) SAS, to acquire an 85.60% stake in Amplitude Surgical SA for €256.80 million. The acquisition, priced at €6.25 per share, will be followed by a tender offer for remaining shares with potential delisting. This move marks Zydus's strategic expansion into the European medical technology market, particularly in lower limb orthopedics.

01Apr 25

Zydus Lifesciences Extends Deal Closure Deadline with Sterling Biotech to 2025

Zydus Lifesciences has extended the closing date for its transaction with Sterling Biotech to September 30, 2025. This nearly two-year extension suggests a complex deal potentially involving intricate negotiations or regulatory approvals. The extended timeline allows both companies to navigate regulatory hurdles, conduct due diligence, align strategic objectives, and address integration challenges. The prolonged period may impact both companies' operations and market positions, with stakeholders anticipating further updates as the new closing date approaches.

28Mar 25

Zydus Lifesciences Extends Deadline for Sterling Biotech Deal to September 2025

Zydus Lifesciences has extended the closing date for its acquisition of Sterling Biotech Limited's API business to September 30, 2025, an 18-month extension from the previous deadline. The extension is due to ongoing efforts by Sterling Biotech to fulfill certain conditions precedent outlined in the Business Transfer Agreement. The deal, initially announced in September 2024, aims to strengthen Zydus Lifesciences' position in the API market.

19Mar 25

Zydus Lifesciences Secures FDA Approval for Apalutamide Tablets, Tapping into Billion-Dollar Market

Zydus Lifesciences has received FDA approval for Apalutamide Tablets (60 mg), a generic version of Erleada® used to treat metastatic castration-sensitive prostate cancer. The drug's annual U.S. sales reach $1099.80 million. Zydus will manufacture the tablets at its Ahmedabad facility. This approval adds to Zydus's 420 approvals and 483 ANDA filings since 2003-04, strengthening its position in the U.S. generic drug market, particularly in oncology.

18Mar 25

Zydus Lifesciences Secures FDA Approval for Manufacturing Apalutamide Tablets

Zydus Lifesciences has received final USFDA approval to manufacture Apalutamide Tablets, 60 mg, a generic version of Erleada® Tablets used for treating metastatic castration-sensitive prostate cancer. The tablets will be produced at their Ahmedabad facility. The original drug had annual U.S. sales of $1099.80 million as of January 2025. This marks Zydus's 420th USFDA approval, adding to their portfolio of 483 ANDAs filed since FY 2003-04.

18Mar 25

Zydus Lifesciences Secures FDA Approval for Prostate Cancer Treatment Drug

Zydus Lifesciences has received final USFDA approval for Apalutamide Tablets, 60 mg, a generic version of Erleada® Tablets. The drug, used for treating metastatic castration-sensitive prostate cancer, had annual sales of $1,099.80 million in the US as of January 2025. Zydus will manufacture the tablets at its Ahmedabad facility. This approval marks Zydus's 420th ANDA approval, strengthening its position in the U.S. pharmaceutical market.

17Mar 25

Zydus Lifesciences Secures FDA Approval for Eluxadoline Tablets, Eyeing $243.7 Million Market

Zydus Lifesciences has received final FDA approval for Eluxadoline Tablets (75 mg and 100 mg), a generic version of Viberzi® Tablets for treating irritable bowel syndrome with diarrhea in adults. The company gains 180 days of shared generic drug exclusivity, positioning it to enter a market with annual US sales of $243.7 million. Zydus plans to manufacture the tablets at its Ahmedabad facility. This approval adds to Zydus' portfolio of 419 approvals and 483 ANDA filings in the US market since FY 2003-04.

17Mar 25

Zydus Lifesciences Secures USFDA Approval for Eluxadoline Tablets, Eyeing $243 Million Market

Zydus Lifesciences has received final USFDA approval to manufacture Eluxadoline Tablets (75 mg and 100 mg) for treating irritable bowel syndrome with diarrhoea in adults. The drug had annual US sales of $243.7 million. As an early ANDA applicant, Zydus is eligible for 180 days of shared generic drug exclusivity. The tablets will be produced at their Ahmedabad facility. As of December 2024, Zydus had 419 approvals and 483 ANDAs filed since 2003-04.

17Mar 25

Zydus Life's API Unit 1 Clears USFDA Inspection; Company Receives Approval for Eluxadoline Tablets

Zydus Lifesciences' API Unit 1 in Ankleshwar, India, passed a USFDA inspection with no observations. The company also received final approval for Eluxadoline Tablets (75 mg and 100 mg) to treat irritable bowel syndrome with diarrhea in adults. The drug, with annual US sales of $243.7 million, will be produced at Zydus's Ahmedabad facility. Zydus is eligible for 180 days of shared generic drug exclusivity. As of December 31, 2024, the company has 419 total approvals and has filed 483 ANDAs since FY 2003-04.

16Mar 25

Zydus Lifesciences Secures FDA Approval for Eluxadoline Tablets with 180-Day Exclusivity

Zydus Lifesciences has received final FDA approval for Eluxadoline Tablets (75 mg and 100 mg) to treat irritable bowel syndrome with diarrhea (IBS-D) in adults. The company gains 180-day shared generic exclusivity, entering a market with $243.7 million annual U.S. sales. Zydus will manufacture the tablets at its Ahmedabad facility, adding to its portfolio of 419 FDA approvals.

15Mar 25

Zydus Lifesciences' API Unit 1 Passes USFDA Inspection with Flying Colors

Zydus Lifesciences Limited's API Unit 1 in Ankleshwar, Gujarat, successfully passed a USFDA surveillance inspection conducted from March 10-14, 2025, with no observations. This outcome validates the company's quality standards, enhances market confidence, and supports its global market access, particularly in the U.S. Zydus promptly disclosed this development to stock exchanges in compliance with SEBI regulations.

13Mar 25

Zydus Lifesciences: Analysts Cut Price Targets Following Acquisition Announcement

Zydus Lifesciences has received cautionary responses from analysts following its $300 million acquisition of Amplitude Surgical, with some firms revising price targets downward. Despite this, the company continues strategic growth initiatives, including an investment in Illexcor Therapeutics for sickle cell disease therapy and FDA approval for a urinary tract infection treatment. Zydus has now reached 419 USFDA approvals, showcasing its expanding product portfolio.

12Mar 25

Zydus Lifesciences Secures FDA Approval for Generic UTI Treatment, Expands Global MedTech Presence

Zydus Lifesciences received FDA approval for generic UTI treatment Methenamine Hippurate Tablets USP, 1 gram. The drug will be produced in Ahmedabad, with US annual sales of $32.6 million. This marks Zydus' 419th FDA approval. Additionally, Zydus plans to acquire 85.6% of Amplitude Surgical SA, a French orthopaedics company, for €257 million. Amplitude Surgical ranks 2nd in France and 6th in Europe for hips and knees, with a presence in over 25 countries and 30 active patents. The acquisition aims to establish MedTech as a significant growth pillar for Zydus.

12Mar 25

Zydus Lifesciences Expands Portfolio with FDA Approval, Plans Major Acquisition in Orthopaedics, and Invests in Sickle Cell Disease Treatment

Zydus Lifesciences is set to acquire an 85.6% stake in Amplitude Surgical, a European orthopaedics company, for €256.8 million. The acquisition marks Zydus' entry into the medical technology sector. Additionally, Zydus received FDA approval for Methenamine Hippurate Tablets and invested in Illexcor Therapeutics for sickle cell disease treatment development. These moves diversify Zydus' portfolio across pharmaceuticals, medical devices, and innovative therapies.

11Mar 25

Zydus Lifesciences Set to Acquire Majority Stake in Amplitude Surgical, Expanding into MedTech Sector

Zydus Lifesciences plans to acquire an 85.6% stake in Amplitude Surgical, a European leader in lower-limb orthopaedics, for €256.8 million at €6.25 per share. This marks Zydus's entry into the medical devices sector. The deal includes a mandatory tender offer for remaining shares and potential delisting. Amplitude Surgical reported €106.0 million in sales and €27.1 million EBITDA for FY2024. The transaction, expected to complete by June 2025, is subject to regulatory approvals and other conditions.

10Mar 25

Zydus Lifesciences Secures FDA Approval for Ketoconazole Shampoo Production

Zydus Lifesciences has received final USFDA approval to manufacture Ketoconazole Shampoo, 2%, a generic equivalent of Nizoral® Shampoo. The U.S. market for this product is valued at $68.89 million annually. Production will occur at Zydus's Changodar facility in Ahmedabad. This approval marks Zydus's 418th USFDA approval, with 483 ANDAs submitted since 2003-04.

10Mar 25

Zydus Lifesciences Secures FDA Approval for Ketoconazole Shampoo, Expanding US Market Presence

Zydus Lifesciences has received final FDA approval to manufacture Ketoconazole Shampoo, 2%, a generic equivalent of Nizoral® Shampoo. The product, used to treat dandruff and fungal infections, has annual US sales of $68.89 million. Zydus plans to produce the shampoo at its Changodar facility in Ahmedabad. This approval adds to the company's portfolio of 418 FDA-approved products and 483 filed ANDAs since 2003-04.

06Mar 25

Zydus Lifesciences Secures FDA Approval for Dasatinib Tablets and Launches ANVIMO for Transplant Patients

Zydus Lifesciences received FDA approval for Dasatinib Tablets to treat chronic myeloid leukemia and acute lymphoblastic leukemia, targeting a $1.81 billion U.S. market. The company also launched ANVIMO in India, a cost-effective treatment for preventing Cytomegalovirus infection in transplant patients, reducing treatment costs by 91%. Zydus has 415 FDA approvals to date and improved its ESG score to 78/100.

05Mar 25

Zydus Lifesciences Secures FDA Approval for Generic Leukemia Treatment, Boosting Product Portfolio

Zydus Lifesciences has received final approval from the USFDA for its generic version of Dasatinib tablets in multiple strengths. The tablets, equivalent to Bristol Myers Squibb's Sprycel®, are used to treat various forms of leukemia. They will be manufactured at Zydus's SEZ facility in Ahmedabad. The US market for Dasatinib tablets was valued at $1,807.7 million as of January 2025. This marks Zydus's 415th USFDA approval, out of 483 ANDAs filed since 2003-04.

05Mar 25

Zydus Lifesciences Secures FDA Approval for Dasatinib Tablets, Expanding Its Oncology Portfolio

Zydus Lifesciences has received final USFDA approval for Dasatinib tablets in six strengths (20, 50, 70, 80, 100, and 140 mg), equivalent to Bristol Myers Squibb's Sprycel®. The drug is used to treat various forms of leukemia, including Ph+ chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia. With annual sales of $1.81 billion in the US as of January 2025, this approval represents a significant market opportunity for Zydus. The company plans to manufacture the tablets at its Ahmedabad facility, marking its 415th regulatory approval.

05Mar 25

Zydus Lifesciences Advances in Transplant Medicine and Vaccine Development

Zydus Lifesciences has launched Anvimo, a new medication for transplant patients, and partnered with the Bill & Melinda Gates Foundation to develop a combination vaccine for shigellosis and typhoid. The vaccine project, starting March 2025, aims to protect children under 5 in endemic areas. Typhoid affects 11-21 million people annually, while Shigella is the second-leading cause of diarrhoeal mortality.

04Mar 25

Zydus Lifesciences to Develop Groundbreaking Combination Vaccine with Gates Foundation Support

Zydus Lifesciences Limited is set to develop the world's first combination vaccine against shigellosis and typhoid, supported by the Bill & Melinda Gates Foundation. The project, starting in March 2025, will combine Zydus' WHO-prequalified Typhoid conjugate vaccine with a partner's Shigella vaccine. This initiative aims to address global health challenges, with typhoid causing 11-21 million cases and 135,000-230,000 deaths annually, while Shigella accounts for 212,000 deaths yearly. The innovative approach could revolutionize childhood immunization in endemic areas, offering a streamlined and cost-effective solution to protect against two lethal enteric diseases.

27Feb 25

Zydus Lifesciences Pioneers New Quadrivalent Influenza Vaccine for Southern Hemisphere 2025

Zydus Lifesciences has launched VaxiFlu-4, India's first quadrivalent vaccine for the 2025 Southern Hemisphere influenza season. The vaccine, cleared by the Central Drug Laboratory, protects against four virus strains recommended by WHO. Developed at Zydus's Vaccine Technology Centre in Ahmedabad, VaxiFlu-4 aims to address the global challenge of seasonal influenza, which causes up to 650,000 deaths annually. The vaccine will be marketed by Zydus Vaxxicare, expanding the company's portfolio of 17 vaccines.

26Feb 25

Zydus Lifesciences Pioneers New Quadrivalent Influenza Vaccine in India

Zydus Lifesciences has become the first company in India to launch a quadrivalent influenza vaccine, VaxiFlu-4, for the 2025 Southern Hemisphere flu season. The vaccine, cleared by the Central Drug Laboratory, protects against four virus strains recommended by WHO. Developed at Zydus's Vaccine Technology Centre in Ahmedabad, it will be marketed by Zydus Vaxxicare. This launch addresses the global influenza burden, which causes up to 650,000 deaths annually worldwide.

24Feb 25

Zydus Lifesciences Secures FDA Approval for Ibuprofen-Famotidine Combo Tablets

Zydus Lifesciences has received final approval from the USFDA for its Ibuprofen (800 mg) and Famotidine (26.6 mg) Tablets. This combination drug aims to provide pain relief while reducing stomach acid production, potentially minimizing ulcer risks associated with NSAID use. The approval allows Zydus to market and distribute these tablets in the U.S., expanding its product portfolio and addressing multiple health concerns simultaneously. This strategic move aligns with industry trends towards combination drugs and could open new revenue streams for the company in the pain management market.

20Feb 25

Zydus Lifesciences Faces New Competition as Amneal Launches Generic Drugs

Amneal Pharmaceuticals has launched a generic version of Asacol (Mesalamine) for ulcerative colitis treatment and received FDA approval for generic Revlimid (Lenalidomide) used in multiple myeloma treatment. These moves introduce new competition in the generic drug market, potentially affecting companies like Zydus Lifesciences. The developments could lead to increased drug accessibility and competitive pricing for patients, while posing challenges for existing market players.