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Zydus Lifesciences Strengthens Semaglutide Market Strategy with Torrent Partnership

Zydus Lifesciences has strengthened its semaglutide injection market strategy by adding Torrent Pharma as a co-marketing partner alongside its existing Lupin collaboration. The March 18, 2026 licensing agreement with Torrent provides semi-exclusive rights to market the innovative 15 mg/3 ml formulation under the SEMBOLIC™ brand, complementing Zydus's own SEMAGLYN™, MASHEMA™, and ALTERME™ brands and Lupin's Semanext® and Livarise® products.

16Mar 26

Zydus Lifesciences: SentyNL Therapeutics Signs Deal With PRG S&T To License Molecule For Hutchinson-Gilford Progeria Syndrome

Sentynl Therapeutics Inc., a wholly-owned subsidiary of Zydus Lifesciences Limited, has entered into a strategic licensing agreement with Korean rare disease specialist PRG S&T to acquire rights to investigational drug candidate Progerinin (SLC-D011) for treating Hutchinson-Gilford Progeria Syndrome. The drug has received FDA orphan drug designation and is currently finalizing a Phase 2A clinical trial, with data expected before the end of the first half of 2026.

16Mar 26

Zydus Lifesciences' Desidustat Receives NMPA Approval for Renal Anaemia Treatment in China

Zydus Lifesciences achieved a major regulatory milestone with NMPA approval for Desidustat tablets in China for treating renal anaemia. The innovative HIF-PHI drug is exclusively licensed to China Medical System Holdings Limited and addresses substantial market opportunities with over 120 million CKD patients in China.

13Mar 26

Zydus Lifesciences Receives Final USFDA Approval for Cevimeline Hydrochloride Capsules

Zydus Lifesciences has secured final USFDA approval for Cevimeline Hydrochloride Capsules 30mg, indicated for treating dry mouth associated with Sjögren's syndrome. The product, to be manufactured at the company's SEZ-II facility in Ahmedabad, has projected annual sales of USD 26.9 million and expands Zydus' regulatory portfolio to 436 approvals.

12Mar 26

Zydus Lifesciences Launches AI-Powered Continuous Glucose Monitors Diasens™ and GlucoLive™

Zydus Lifesciences Limited launched Diasens™ and GlucoLive™, AI-powered continuous glucose monitoring devices designed for diabetic, CKD, and post-transplant patients. The devices automatically stream readings every three minutes to smartphones without manual scanning, partnering with TatvaCare's GoodFlip™ app for comprehensive digital health management. This addresses India's significant diabetes burden of over 101 million adults, moving beyond episodic monitoring to continuous, AI-enhanced glucose surveillance with remote clinician oversight.

28Feb 26

Zydus Lifesciences Receives USFDA Final Approvals for Ivermectin and Dapsone Tablets

Zydus Lifesciences Limited received final USFDA approvals on February 28, 2026, for Ivermectin Tablets USP, 3 mg and Dapsone Tablets USP in 25 mg and 100 mg strengths. The products target annual US markets worth USD 14.8 million and USD 8.4 million respectively, with manufacturing planned at Ahmedabad facilities and distribution through Viona Pharmaceuticals Inc. These approvals bring the company's total USFDA approvals to 434, with 505 ANDAs filed since FY 2003-04.

27Feb 26

Zydus Lifesciences Completes Pivotal Study for Pembrolizumab Biosimilar FYB206

Zydus Lifesciences announced successful completion of the pivotal Dahlia pharmacokinetic study for FYB206, a pembrolizumab biosimilar in-licensed from Formycon AG for U.S. and Canadian markets. The study demonstrated bioequivalence to Keytruda, completing the clinical data package and clearing the pathway for near-term USFDA BLA filing in the immuno-oncology biosimilar market.

26Feb 26

Zydus Lifesciences Announces Day 1 Semaglutide Launch with Innovative Pen Device

Zydus Lifesciences announces strategic Day 1 patent expiry launch of Semaglutide injection in India featuring innovative reusable pen delivery system. The company will market the diabetes and obesity treatment under three brands with DCGI approval, addressing India's significant health burden of 8.9 crore diabetic adults.

19Feb 26

Zydus Lifesciences Injectable Plant Passes USFDA Inspection with Zero Observations

Zydus Lifesciences Limited successfully completed a USFDA Pre Approval Inspection at its Injectable Medical Devices facility in Ahmedabad with NIL observations. The inspection was conducted from February 16-19, 2026, at the company's Unit 9 facility located at Zydus Biotech Park, Changodar. This positive regulatory outcome demonstrates compliance with USFDA manufacturing standards and was disclosed under SEBI Regulation 30 requirements.

19Feb 26

Zydus Lifesciences Receives USFDA Final Approval for Bosentan Tablets for Pediatric PAH Treatment

Zydus Lifesciences Limited has received final USFDA approval for Bosentan tablets for oral suspension, 32 mg, a generic version of Tracleer® indicated for treating Pulmonary Arterial Hypertension in children aged 3 years and older. The dual endothelin receptor antagonist targets a USD 9.3 mn annual US market and will be manufactured at the company's SEZ, Ahmedabad facility. This approval brings Zydus's total USFDA approvals to 432, with 505 ANDAs filed since FY 2003-04, strengthening its presence in the specialized pediatric pharmaceutical segment.

19Feb 26

Zydus Lifesciences Launches India's First Indigenous Aflibercept Biosimilar ANYRA™

Zydus Lifesciences Limited launched ANYRA™, India's first indigenously developed Aflibercept 2 mg biosimilar, on February 19, 2026, following an agreement with Regeneron Pharmaceuticals and Bayer. The biosimilar treats multiple retinal conditions including neovascular AMD, diabetic retinopathy, and retinal vein occlusions, addressing the needs of millions of Indian patients affected by these vision-threatening diseases. With India hosting over 100 million diabetics and millions suffering from retinal disorders, ANYRA™ enhances access to affordable anti-VEGF therapy. Zydus maintains India's largest biosimilar portfolio with more than 13 biosimilars developed and manufactured domestically.

17Feb 26

Zydus Lifesciences Launches PEPAIR™, India's First Affordable Drug-Free Respiratory Device at Rs. 990

Zydus Lifesciences has launched PEPAIR™, India's first affordable OPEP device priced at Rs. 990, targeting over 90 lakh patients with chronic respiratory conditions. The drug-free, handheld device features a patented 3-resistance system designed to improve breathing in COPD, asthma, and bronchiectasis patients. Developed in partnership with AeroDel Technology Innovations, the launch strengthens Zydus's position as a leading respiratory player in India.

15Feb 26

Zydus Lifesciences Q3FY26 Results and Earnings Call Highlight Strategic Growth

Zydus Lifesciences delivered strong Q3FY26 performance with consolidated revenue of ₹68,645 million (30.30% YoY growth) and net profit of ₹10,421 million. The company held its post-results earnings call on February 10, 2026, where management discussed strategic initiatives including the upcoming Saroglitazar USFDA filing for PBC indication, biosimilar partnerships for Pembrolizumab and Ranibizumab, and the successful launch of Zycubo for Menkes disease treatment. All key business segments showed robust growth with North America up 16%, India branded formulations up 14%, and international markets growing 38% year-on-year.

14Feb 26

Zydus Lifesciences Receives USFDA Final Approval for Ammonium Lactate Cream, 12%

Zydus Lifesciences Limited has received final USFDA approval for Ammonium Lactate Cream, 12%, a topical prescription medication for dry skin conditions including xerosis and ichthyosis vulgaris. The product will be manufactured at the company's Changodar facility and distributed by Viona Pharmaceuticals Inc. With annual US sales of USD 15 mn, this approval brings Zydus's total USFDA approvals to 430 out of 505 ANDAs filed since FY 2003-04.

12Feb 26

Zydus Lifesciences Settles US Patent Dispute with Astellas for USD 120 Million

Zydus Lifesciences Limited has settled its US patent litigation with Astellas Pharma Inc. over Myrbetriq (Mirabegron) for USD 120 million plus ongoing licensing fees until September 2027. The settlement concludes all legal disputes between the companies and allows Zydus to continue marketing its generic Mirabegron in the United States. This resolution follows the company's earlier intimation about the patent litigation dated April 17, 2025.

09Feb 26

Zydus Lifesciences Board Reviews Exchange Penalties for Technical Non-Compliance with Meeting Intimation Rules

Zydus Lifesciences Limited's board reviewed penalties of ₹11,800 each from BSE and NSE for technical non-compliance with Regulation 29 regarding board meeting intimation. The issue arose from different holiday calendar interpretations between Ahmedabad (company's location) and Mumbai (exchanges' location) for a November 6, 2025 meeting. The board acknowledged the inadvertent error, confirmed penalty payments, and committed to strengthened compliance processes.

31Jan 26

Zydus Lifesciences Announces Superannuation of Senior Vice President Corporate Affairs

Zydus Lifesciences Limited announced the superannuation of Mr. Manoj Kumar Kamra, Senior Vice President-Corporate Affairs, effective January 31, 2026. The disclosure was made under Regulation 30 of SEBI listing regulations and related circulars, with formal communication filed to BSE and NSE by Company Secretary Dhaval N. Soni.

27Jan 26

Zydus Lifesciences Schedules Board Meeting on February 9, 2026 for Q3FY26 Financial Results

Zydus Lifesciences Limited has scheduled its Board of Directors meeting for Monday, February 9, 2026, to consider and approve unaudited financial results for the quarter and nine months ended December 31, 2025. The company has notified both BSE and NSE in compliance with SEBI Regulation 29(1), and implemented a trading window closure for Directors and Designated Persons until February 11, 2026, with trading resuming on February 12, 2026.

23Jan 26

Zydus Lifesciences USFDA Inspection at Ankleswar Plant Concludes with 3 Observations

Zydus Lifesciences Limited completed a USFDA inspection at its Unit-2 manufacturing plant in Ankleswar, Gujarat, from January 19-23, 2026. The inspection concluded with 3 observations, with no data integrity related issues identified. The company has committed to working closely with the USFDA to address the observations expeditiously and made this disclosure under SEBI Regulation 30 requirements.

20Jan 26

Zydus Lifesciences ESG Rating Improved to 84/100 by S&P Global

Zydus Lifesciences Limited announced that S&P Global has revised its Corporate Sustainability Assessment ESG Score from 83/100 to 84/100 for 2025. The company had initially received the 83/100 rating in December 2025, which has now been upgraded by one point. This improvement reflects enhanced performance in environmental, social, and governance criteria as assessed by S&P Global's sustainability evaluation framework.

15Jan 26

Zydus Lifesciences Completes Agenus Acquisition, Establishes Zylidac Bio LLC for US Biologics Manufacturing

Zydus Lifesciences Limited completed its strategic acquisition of Agenus Inc.'s biologics manufacturing facilities and equity stake on January 15, 2026, following CFIUS and regulatory approvals. The transaction establishes Zylidac Bio LLC as a US-based CDMO subsidiary operating facilities in Emeryville and Berkeley, California, while securing exclusive manufacturing rights for Agenus' Phase 3 immuno-oncology candidates and commercialization rights in India and Sri Lanka.

15Jan 26

Zydus Lifesciences Receives USFDA Final Approval for Eltrombopag Tablets

Zydus Lifesciences announced on January 15 that it secured final USFDA approval for Eltrombopag Tablets in four different strengths for treating thrombocytopenia. The approval targets a significant USD 1262.50 million US market opportunity, with manufacturing planned at the company's SEZ facility in Ahmedabad, bringing their total USFDA approvals to 429 out of 505 filed ANDAs since FY 2003-04.

13Jan 26

Zydus Lifesciences Receives FDA Approval for ZYCUBO, First Treatment for Rare Menkes Disease

Zydus Lifesciences achieved a major regulatory milestone with FDA approval of ZYCUBO for Menkes disease treatment through its US subsidiary Sentynl Therapeutics. This represents the first approved therapy for the rare genetic condition in the United States. Clinical trials showed 177.1 months median survival for early treatment versus 17.6 months for untreated patients, demonstrating nearly 80% reduction in death risk.

10Jan 26

Zydus Lifesciences Dissolves French Subsidiary Ampliman 2 Without Business Impact

Zydus Lifesciences Limited dissolved its French subsidiary Ampliman 2 effective January 9, 2026, without liquidation. All assets and liabilities were transferred to parent company Zydus MedTech (France) S.A.S. The pharmaceutical company confirmed this restructuring will not impact business operations, representing a streamlining of its European subsidiary structure.

02Jan 26

Zydus Lifesciences Dissolves Luxembourg Subsidiary Auroralux S.A.S. Effective December 31, 2025

Zydus Lifesciences has announced the dissolution of its wholly owned subsidiary Auroralux S.A.S., Luxembourg, effective December 31, 2025, without liquidation. All assets and liabilities will be transferred to Zydus MedTech (France) S.A.S., ensuring business continuity with no operational impact.

30Dec 25

Zydus Lifesciences Receives ₹2.8 Crore GST Demand Order for FY 2018-19

Zydus Lifesciences Limited received a ₹2.8 crore GST demand order from Gujarat tax authorities for alleged inadmissible Input Tax Credit availment during FY 2018-19. The order was issued under section 74 of CGST Act, 2017, and received on December 29, 2025. The company plans to appeal the decision, citing favorable precedents from higher courts, and maintains there will be no material financial impact on operations.

24Dec 25

Zydus Lifesciences Further Extends Sterling Biotech API Acquisition to June 2026

Zydus Lifesciences has announced a second extension for its Sterling Biotech API business acquisition, moving the deadline to June 30, 2026. The extension follows ongoing processes at Sterling Biotech to complete conditions precedent outlined in the Business Transfer Agreement originally signed in September 2024.

24Dec 25

Zydus Partners with Bioeq for US Biosimilar Rights to NUFYMCO

Zydus Lifesciences has formed a strategic partnership with Swiss biopharmaceutical company Bioeq AG for the commercialisation of NUFYMCO, an interchangeable biosimilar to Lucentis (Ranibizumab) in the US market. The collaboration involves Zydus handling commercialisation while Bioeq manages development, manufacturing and supply, targeting a $210 million market opportunity with FDA approval confirmed on December 18, 2025.

23Dec 25

High Court Permits Zydus Lifesciences to Manufacture and Export Semaglutide

Zydus Lifesciences has received High Court permission to manufacture semaglutide, a medication used for diabetes treatment and weight management. The court order also allows the company to export the drug to specific international markets. This regulatory approval enables Zydus to enter semaglutide production for both domestic and select international markets, potentially expanding its presence in the diabetes care and weight management sectors.

19Dec 25

Zydus Signs Exclusive Agreement with Myriad Genetics for Cancer Testing in India

Zydus Lifesciences Limited has entered into an exclusive partnership with US-based Myriad Genetics to introduce advanced cancer-risk assessment diagnostic tests in India. The agreement covers three key tests: MyRisk Hereditary Cancer Test analyzing 63 genes for hereditary cancer risk, MyChoice HRD Plus Test for ovarian cancer treatment decisions, and Prolaris Test for prostate cancer prognosis, marking a significant expansion in precision oncology services for Indian patients.

16Dec 25

Zydus Lifesciences ESG Score Improves to 69.4, Mourns Senior Executive Loss

Zydus Lifesciences has received an enhanced ESG score of 69.4 for FY25 from SES ESG Research, improving from the previous year's 67.8, maintaining its Medium Risk category. The company also announced the passing of Mr. Samir Desai, President-BU Biologics, ensuring regulatory compliance through timely disclosures to stock exchanges.

16Dec 25

Zydus Lifesciences: Sentynl Therapeutics Gets FDA Acceptance for CUTX-101 NDA

Zydus Lifesciences announced that Sentyln Therapeutics received FDA acceptance for CUTX-101 NDA resubmission targeting Menkes disease treatment, with a PDUFA date of January 14, 2026. The investigational therapy demonstrated significant clinical efficacy with 80.00% reduction in death risk and could become the first approved treatment for this rare pediatric genetic condition.

12Dec 25

Zydus Lifesciences Secures 99.89% Shareholder Approval for ₹5,000 Crore Fundraising

Zydus Lifesciences achieved a decisive 99.89% shareholder approval for its ₹5,000 crore fundraising initiative through postal ballot voting conducted on December 12, 2025. The approved framework allows flexible fund raising through various instruments including equity shares, convertible securities, and debentures via methods like QIP, rights issue, and preferential allotment. Additionally, the company received its first NMPA approval in China for Venlafaxine ER Capsules, marking a significant milestone in its international expansion strategy.

12Dec 25

Zydus Life Sciences Announces Postal Ballot Voting Results for Special Resolution

Zydus Life Sciences Limited completed its postal ballot voting process for a special resolution on December 12, 2025, with remote e-voting conducted through CDSL from November 13 to December 12, 2025. The company reported voting results across different shareholder categories and submitted compliance documents to BSE and NSE under SEBI Listing Regulations.

10Dec 25

Zydus Lifesciences Launches Bone Health Drug Zyrifa For Cancer Patients At ₹12,495

Zydus Lifesciences has launched Zyrifa, a specialized bone health medication priced at ₹12,495 designed to prevent skeletal complications in cancer patients. The launch strengthens the company's oncology portfolio and demonstrates its commitment to addressing critical healthcare needs in cancer treatment.

10Dec 25

Zydus Lifesciences Partners with Formycon for Exclusive Biosimilar Keytruda Deal in North America

Zydus Lifesciences has formed an exclusive partnership with Formycon for licensing and supply of a biosimilar to Keytruda in the US and Canada. This strategic collaboration strengthens the company's biosimilar portfolio and expands its presence in key North American pharmaceutical markets. The partnership provides exclusive access to advanced biosimilar technology for one of the most significant oncology treatments.

04Dec 25

Zydus Lifesciences' Jarod Injectable Facility Receives USFDA Inspection Report

Zydus Lifesciences' Jarod Injectable Facility has received a 'Voluntary Action Indicated' (VAI) classification from the USFDA following a Good Manufacturing Practices inspection. The VAI status indicates minor deficiencies that require attention but allows continued operations. Zydus is expected to address these concerns voluntarily, demonstrating its commitment to maintaining high-quality manufacturing standards.

25Nov 25

Zydus Lifesciences Secures USFDA Approval for Cardiac Medication

Zydus Lifesciences has obtained final approval from the U.S. FDA for its Verapamil Hydrochloride Extended-Release Tablets, a medication used to treat cardiac conditions. This approval allows Zydus to market and distribute the product in the United States, expanding its product portfolio and strengthening its position in the U.S. pharmaceutical market. Verapamil Hydrochloride is a calcium channel blocker used for treating high blood pressure, chest pain, and certain heart rhythm disorders.

19Nov 25

Zydus Foundation Loses Wholly-Owned Subsidiary Status Following Share Allotment

Zydus Life Science announced that its wholly-owned subsidiary, Zydus Foundation, has ceased to hold that status following a preferential share allotment. On November 19, 2025, Zydus Foundation issued 4,50,000 equity shares to Ramanbhai Foundation, a public charitable trust. Zydus Life Science now retains 50,000 equity shares in Zydus Foundation. The transaction was conducted at fair value, determined by a SEBI-registered valuer, and on an arm's length basis. The financial impact on Zydus Life Science appears minimal, with no contribution to income or net worth for the fiscal year ending March 31, 2025.

14Nov 25

Zydus Lifesciences Expands Oncology Portfolio with FDA Approval for Prostate Cancer Drug

Zydus Life Science has obtained final USFDA approval for Leuprolide Acetate Injection, used in the palliative treatment of advanced prostatic cancer. The drug, with estimated annual U.S. sales of $69.00 million, will be manufactured at Zydus' oncology injectable facility in Ahmedabad. This approval marks Zydus' 427th USFDA approval, strengthening its oncology portfolio and U.S. market presence.

14Nov 25

Zydus Lifesciences: CE Mark for Surgical Robot, USFDA Approval for MS Drug, and FDA Inspection of Oncology Facility

Zydus Life Science has received CE mark approval for its robotic surgical system 'Andy', USFDA approval for Diroximel Fumarate Delayed-Release Capsules to treat multiple sclerosis, and completed a US FDA inspection at its oncology injectable facility. The 'Andy' system combines navigation technology with robotic assistance for orthopaedic surgeries. The multiple sclerosis treatment has expected annual sales of $999.40 million in the US. The FDA inspection resulted in two observations with no data integrity issues.

13Nov 25

Zydus Lifesciences Reports Robust Q2 FY26 Performance with 17% Revenue Growth

Zydus Life Science reported robust Q2 FY26 results with consolidated revenues of Rs 61.20 billion, up 17% year-on-year. EBITDA margin improved to 32.90%, with EBITDA and net profit both up 38%. US formulations business grew 14%, India branded formulations increased 9%, international markets surged 39%, and consumer wellness rose 31%. Key developments include specialty portfolio expansion, international acquisition of Comfort Click Limited, launch of India's first trivalent influenza vaccine, positive clinical trial results for Saroglitazar Magnesium, and acquisition of Amplitude Surgical.

11Nov 25

Zydus Lifesciences Secures Maiden NMPA Approval in China for Antidepressant Medication

Zydus Lifesciences has received approval from China's National Medical Products Administration (NMPA) for Venlafaxine Extended-Release Capsules in 75mg and 150mg strengths. This marks the company's first entry into the Chinese pharmaceutical market through the NMPA regulatory pathway. Venlafaxine, an antidepressant in the serotonin-norepinephrine reuptake inhibitor (SNRI) class, is used to treat major depressive disorder and anxiety disorders. The approval opens up opportunities for Zydus in one of the world's largest healthcare markets, potentially strengthening its global position.

07Nov 25

Zydus Lifesciences Reports Strong Q2 FY26 Performance, Maintains FY26 Growth Targets and Receives Tentative USFDA Approval for Olaparib Tablets

Zydus Life Science reported robust Q2 FY26 results with revenue up 17% to ₹61,232 million and net profit up 38% to ₹12,586 million. The company saw growth across all segments, with US Formulations up 13.5%, India Formulations up 8.4%, Consumer Wellness up 30.7%, and International Markets up 39.4%. Zydus completed acquisitions of Amplitude Surgical SA and Comfort Click Limited, expanding its medical devices and wellness portfolios. The company also received tentative USFDA approval for Olaparib tablets and reported positive results for Saroglitazar Magnesium in PBC trials.

06Nov 25

Zydus Lifesciences Reports Growth in US Formulations and Advances in Beta-Thalassemia Treatment

Zydus Life Science announced a 13.5% growth in its US formulations business. The company's novel oral treatment, Desidustat, received Orphan Drug Designation from the FDA for beta-thalassemia treatment. This designation offers potential benefits including market exclusivity, financial incentives, and development support. Desidustat, a HIF-prolyl hydroxylase inhibitor, shows promise in increasing hemoglobin and red blood cell counts, potentially improving life quality for beta-thalassemia patients.

06Nov 25

Zydus Lifesciences Reports Strong Q2 Growth with 38% EBITDA Jump and Board Approves ₹5,000 Crore Fundraising Plan

Zydus Lifesciences reported impressive Q2 financial results with revenue increasing 16.41% YoY to ₹6,100.00 crore. EBITDA grew 38.01% to ₹2,015.00 crore, and EBITDA margin expanded by 5.01 percentage points to 32.92%. The company's board has approved a fundraising plan of up to ₹5,000.00 crores through various securities, subject to approvals.

05Nov 25

Zydus Life Sciences Secures FDA Approval for Ahmedabad Manufacturing Facility

Zydus Life Sciences' SEZ-II manufacturing facility in Ahmedabad successfully passed a U.S. FDA Pre-Approval Inspection from August 11-14, 2025, receiving zero observations and a 'No Action Indicated' (NAI) classification. The company also received tentative USFDA approval for Budesonide delayed-release capsules on November 4, 2025. As of September 30, 2025, Zydus has 425 ANDA approvals and has filed 487 ANDAs since FY 2003-04.

01Nov 25

Zydus Lifesciences Faces ₹74.23 Crore IGST Demand, Plans to Appeal

Zydus Lifesciences has received a tax demand of ₹74.23 crores from Indian authorities for alleged excess IGST refund claims on exports from April 2018 to March 2024. The order, issued by the Joint Commissioner of Common Adjudication Authority CGST in Ahmedabad, Gujarat, covers four GST registrations across different states. The company plans to challenge the order, stating it has no material financial impact. The dispute centers on the use of CIF value instead of FOB value for export calculations.

29Oct 25

Zydus Lifesciences Secures USFDA Approval for Baddi Manufacturing Plant

Zydus Lifesciences' Baddi manufacturing facility has received approval from the U.S. Food and Drug Administration (USFDA) with a Voluntary Action Indicated (VAI) classification. The USFDA conducted an inspection at the facility from August 4 to August 13, and the company has received the Establishment Inspection Report (EIR), concluding the inspection as closed. This approval strengthens Zydus Lifesciences' position in the pharmaceutical market, particularly for products destined for the U.S. market.

26Oct 25

Zydus Lifesciences Completes 100% Acquisition of Amplitude Surgical SA

Zydus Lifesciences has finalized its acquisition of French company Amplitude Surgical SA through its subsidiary Zydus MedTech France SAS. The process, which began in July 2025 with an 85.60% stake, concluded on October 24, 2025, with the acquisition of the remaining 14.40% share capital and voting rights. This strategic move strengthens Zydus's position in the European medical technology market, particularly in lower-limb orthopedics. The company informed stock exchanges of this development, citing a slight delay due to Diwali holidays.

24Oct 25

Zydus Lifesciences Secures Health Canada Approval for Generic Mesalamine Suppositories

Zydus Life Science received a Notice of Compliance from Health Canada for its generic Mesalamine suppositories 1000 mg, used to treat ulcerative proctitis. The annual sales of Mesalamine suppositories in Canada are 4.86 million Canadian dollars. The medication will be manufactured at Zydus's facility in Changodar, Ahmedabad, Gujarat, India. This approval allows Zydus to enter the Canadian pharmaceutical market, potentially increasing its global presence and revenue while providing Canadian patients with an additional treatment option.

17Oct 25

Zydus Healthcare Faces Rs 2.17 Million Tax Demand from CGST Authority

Zydus Healthcare Limited, a subsidiary of Zydus Life Science, has received a tax demand order of Rs 2.17 million from the Assistant Commissioner of CGST, Cuttack-I Division, Odisha. The order covers disallowed Input Tax Credit and short payment of tax under the Reverse Charge Mechanism for April 2018 to March 2023. An equal penalty amount has been imposed. Zydus Healthcare intends to challenge the order through an appeal, stating there is no material financial impact on either the subsidiary or the parent company. The company disclosed this information to stock exchanges on October 17, 2023, in compliance with SEBI regulations.

06Oct 25

Zydus Lifesciences Secures Regulatory Approvals in North America

Zydus Life Science has received USFDA approval for Deflazacort oral suspension (22.75 mg/mL) for treating Duchenne Muscular Dystrophy in patients 5 years and older. The product will be manufactured in Italy. This approval brings Zydus's total USFDA approvals to 424, with 487 ANDAs filed since FY 2003-04. Additionally, Zydus obtained Health Canada approval for Liothyronine tablets in 5 mcg and 25 mcg strengths, expanding its presence in the North American pharmaceutical market.

01Oct 25

Zydus Lifesciences Receives FDA Complete Response Letter for CUTX-101 Drug Application

Sentynl Therapeutics, a U.S. subsidiary of Zydus Life Science, received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for CUTX-101, a treatment for Menkes disease. The CRL focuses on manufacturing concerns, specifically the need for a CGMP inspection of the production facility. Zydus has already responded to the FDA's re-inspection, demonstrating CGMP compliance. CUTX-101 is a subcutaneous injectable formulation of copper histidinate designed to treat Menkes disease, a rare genetic disorder affecting copper absorption. The company plans to request a meeting with the FDA to discuss the CRL and resubmission of the NDA.

25Sept 25

Zydus Lifesciences Gets ₹35.90 Crore Tax Demand Dropped, ₹3.35 Crore Liability Confirmed

Zydus Lifesciences announced that CGST authorities have dropped tax demands worth ₹35.90 crore out of a total ₹39.25 crore. A liability of ₹3.35 crore plus interest and penalty remains, related to CENVAT credit on sales commission paid to foreign entities. The company plans to appeal this remaining demand. Zydus states there is no material financial impact on its operations from the confirmed liability. Shares of Zydus Lifesciences closed at ₹1,018.90, down 1.57%.

21Sept 25

Zydus Lifesciences' Ahmedabad Oncology Facility Receives Improved FDA Classification

Zydus Lifesciences' oncology injectable manufacturing facility in Ahmedabad has received an improved classification from the U.S. FDA. The facility's status has been upgraded from Official Action Indicated (OAI) to Voluntary Action Indicated (VAI) following a GMP follow-up inspection in June 2025. This change indicates that while some issues were found, they can be addressed through voluntary action, potentially allowing for smoother operations and increased production. The company officially disclosed this development to stock exchanges on September 21, 2025.

15Sept 25

Zydus Lifesciences' ZyVet Launches First Generic Veterinary Medications for Canine Urinary Incontinence and Heart Care

Zydus Life Science's subsidiary, ZyVet Animal Health, has introduced two generic medications for pets: the first FDA-approved generic phenylpropanolamine hydrochloride tablets for canine urinary incontinence and generic Furosemide tablets for managing congestive heart failure in dogs and cats. These cost-effective alternatives aim to improve pet care accessibility and affordability. The company emphasizes the importance of removing cost barriers to compassionate care and providing high-quality treatment options for all pets.

08Sept 25

Zydus Lifesciences' Jarod Injectable Plant Receives 4 Observations in USFDA Inspection

Zydus Lifesciences announced that a recent USFDA inspection of its Jarod injectable plant concluded with four observations. The company emphasized that no data integrity issues were identified during the inspection. This outcome suggests that the company's manufacturing practices largely align with USFDA standards, and the limited number of observations may allow for prompt resolution. The inspection's results are significant for Zydus Lifesciences' regulatory compliance efforts and its operations in the U.S. pharmaceutical market.

05Sept 25

Zydus Lifesciences Concludes INR 600 Crore Share Buyback with 8.66 Times Oversubscription

Zydus Lifesciences has concluded its share buyback program, repurchasing 59,70,149 equity shares at INR 1,005 per share, totaling INR 599.99 crore. The offer was oversubscribed by 8.66 times, with 45,308 valid bids received for 5,16,87,188 shares. The buyback period ran from February 29 to March 6, 2024, with settlement on March 14. Post-buyback, the company's paid-up share capital will decrease from 101,22,04,139 to 100,62,33,990 shares. The Zydus Family Trust was the largest participant, accounting for 64.53% of repurchased shares.

05Sept 25

Zydus Lifesciences Bolsters Management Team with Appointment of Nitin D. Parekh as President (Special Projects)

Zydus Lifesciences Limited has appointed Nitin D. Parekh as President (Special Projects) for a two-year term starting September 8, 2025. Parekh, 64, brings over 40 years of experience in finance, strategy, legal, and IT sectors. He previously served as the company's CFO for more than 16 years. The appointment aims to strengthen the management team amid growing business complexity. Parekh's expertise in M&A, negotiations, and capital structure design is expected to contribute to the company's future growth.

04Sept 25

Zydus Lifesciences and Synthon Forge Alliance for Generic Ozanimod in U.S. Market

Zydus Lifesciences' subsidiary has entered an exclusive licensing agreement with Synthon BV for generic Ozanimod capsules in the U.S. Synthon will handle regulatory approval and manufacturing, while Zydus will commercialize the product. The total addressable market for Ozanimod in the U.S. is approximately $637 million. Synthon's first-filer status grants potential 180-day shared exclusivity. Ozanimod treats multiple sclerosis and ulcerative colitis. This partnership aims to expand access to affordable treatment options.

03Sept 25

Zydus Lifesciences May Benefit from Potential GST Exemption on Cancer Medications

The Indian government is considering exempting cancer medications from GST, which could positively impact Zydus Lifesciences. This policy change may make cancer drugs more affordable and accessible, potentially increasing demand for Zydus's oncology products. The company could see increased sales volumes and market share in the cancer treatment sector. Zydus recently launched VaxiFlu™, India's first trivalent influenza vaccine, showcasing its innovation in healthcare.

02Sept 25

Zydus Lifesciences Launches VaxiFlu™: India's First Trivalent Influenza Vaccine

Zydus Lifesciences has introduced VaxiFlu™, India's first trivalent influenza vaccine, aligning with WHO's latest recommendations. The vaccine incorporates updated strains for optimal protection against current influenza variants. VaxiFlu™ is recommended for individuals aged 6 months and above, addressing a global health concern that causes 3-5 million severe illnesses annually.

29Aug 25

Zydus Lifesciences' Saroglitazar Shows Promise in Primary Biliary Cholangitis Trial

Zydus Life Science reported positive results from its Epic-III Phase 2(B)/3 clinical trial of Saroglitazar Magnesium for Primary Biliary Cholangitis (PBC) treatment. The trial demonstrated a 48.50% biochemical response rate. The company plans to submit for regulatory approval in Q1 2026, potentially offering a new treatment option for this progressive liver disease.

20Aug 25

Zydus Lifesciences Reports 6% Revenue Growth in Q1, Driven by Strong Performance Across Key Markets

Zydus Lifesciences posted consolidated revenues of ₹65.70 billion in Q1 FY2024, up 6% year-on-year. EBITDA reached ₹20.90 billion with a 31.8% margin. Net profit increased 3% to ₹14.70 billion. US Formulations revenue grew 3% to ₹31.80 billion. India Geography saw 6% overall growth, with branded formulations outpacing the market at 9%. International markets' formulations business grew 37% to ₹7.30 billion. The company completed strategic acquisitions and partnerships, including Amplitude Surgical and Braile Biomedica. Zydus maintains its guidance for single-digit growth in the US market and expects strong double-digit growth in international markets for the fiscal year.

13Aug 25

Zydus Lifesciences Completes USFDA Inspection Successfully, Projects Single-Digit US Growth

Zydus Life Science has successfully completed a USFDA inspection at its Ahmedabad facility with no issues identified. The company projects single-digit growth for its US business with EBITDA margins exceeding 26%. In contrast, international markets are expected to see high-teens to mid-20s percentage growth. Zydus plans to launch over 30 new products in the US, including Ibrance. The company reported a 5.9% YoY increase in total revenue to ₹65,737.00 million, with EBITDA at ₹20,885.00 million. Zydus continues to invest heavily in R&D, spending ₹4,856.00 million or 7.4% of revenues. The company has also completed strategic acquisitions to expand its global footprint.

12Aug 25

Zydus Lifesciences Posts Robust Q1 Results with 6% Revenue Growth

Zydus Life Science's Q1 FY24 consolidated revenue increased by 5.9% to ₹65,737.00 million, with net profit rising 3.3% to ₹14,668.00 million. The India Formulations business grew 8%, US Formulations 2.9%, and International Markets 36.8%. The company maintained an EBITDA margin of 31.8% and provided future guidance of 26%. R&D expenses were ₹4,856.00 million, representing 7.4% of total revenues. The company launched three new products in the US market and received approvals for six ANDAs.

11Aug 25

Zydus Lifesciences Secures USFDA Approval for Diltiazem Hydrochloride Tablets

Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (USFDA) for its Diltiazem Hydrochloride Tablets. This approval allows the company to market and distribute the medication in the United States. Diltiazem Hydrochloride, a calcium channel blocker, is used to treat hypertension, angina, and certain arrhythmias. The approval is expected to strengthen Zydus Lifesciences' position in the U.S. pharmaceutical market and potentially open new revenue streams.

29Jul 25

Zydus Lifesciences Acquires 85.6% Stake in France's Amplitude Surgical for €256.8 Million

Zydus Life Science has completed the acquisition of an 85.6% stake in Amplitude Surgical SA, a French orthopedic surgical technology firm, for €256.8 million. The deal, executed through Zydus MedTech (France) SAS, was finalized on July 29, 2025, at €6.25 per share. A mandatory tender offer for remaining shares will be filed, with Zydus aiming to hold over 90% of Amplitude's capital. Olivier Jallabert will continue as CEO of Amplitude Surgical. This acquisition expands Zydus's global footprint in the orthopedic market and enhances its healthcare portfolio.

16Jul 25

Zydus Lifesciences Secures FDA Approval for Celecoxib Capsules, Expanding Pain Management Portfolio

Zydus Lifesciences has obtained final FDA approval for Celecoxib Capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths. This generic version is equivalent to Celebrex® Capsules, used for pain management. Celecoxib, an NSAID, treats conditions like arthritis and menstrual pain. The U.S. market for Celecoxib capsules was $122.60 million annually. Zydus will manufacture the capsules at its Ahmedabad facility. This approval adds to Zydus's 428 total FDA approvals and 492 ANDA filings.

15Jul 25

Zydus Lifesciences Secures USFDA Approval for Celecoxib Capsules

Zydus Lifesciences has obtained final USFDA approval for Celecoxib Capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths. This generic version is equivalent to Celebrex® Capsules, used for treating various inflammatory conditions. The annual U.S. sales for Celecoxib capsules were $122.60 million as of May 2025. Zydus plans to manufacture these capsules at its SEZ unit in Ahmedabad. The company now has 428 USFDA approvals and has filed 492 ANDAs since FY 2003-04.

14Jul 25

Zydus Lifesciences Expands U.S. Presence with New Subsidiary for Biologics Acquisition

Zydus Lifesciences has formed a new U.S. subsidiary, Zylidac Bio LLC, to acquire biologics facilities from Agenus, a biotechnology company. This strategic move aims to strengthen Zydus' position in the U.S. biologics market and enhance its capabilities in developing and manufacturing biological products. The acquisition is expected to boost Zydus' presence in the U.S. pharmaceutical market and potentially accelerate its research and development efforts in the biologics field.

26Jun 25

Zydus Lifesciences May Face Challenges as US Halts Support for Global Vaccine Alliance Gavi

The US Health Secretary has announced a halt to support for the Global Vaccine Alliance Gavi, raising concerns about its effects on pharmaceutical companies involved in global vaccine production and distribution. This decision could potentially impact Zydus Lifesciences, a prominent Indian pharmaceutical company. The full extent of the impact remains uncertain and will depend on factors such as the duration of US withdrawal, responses from other Gavi donors, and potential changes in global vaccine procurement strategies.

18Jun 25

Zydus Lifesciences' Oncology Injectable Facility Concludes USFDA Inspection with Two Observations

Zydus Lifesciences announced the completion of a USFDA inspection at its oncology injectable facility in Ahmedabad, Gujarat. The inspection resulted in two observations, which are not uncommon in FDA inspections. The company's response to these observations will be crucial for maintaining its position in the U.S. pharmaceutical market, particularly in the oncology sector.

16Jun 25

Zydus Healthcare Appoints Industry Veteran Swati Dalal as New Managing Director

Zydus Life Science's subsidiary, Zydus Healthcare Ltd, has appointed Swati Dalal as its new Managing Director, effective June 16, 2025. Dalal, with over 30 years of experience in the pharmaceutical industry, joins from Abbott India Ltd where she held the same position. The Board of Directors has appointed her for a five-year term, signaling a commitment to long-term strategic planning. This leadership transition is expected to leverage Dalal's expertise to drive growth and innovation in the competitive pharmaceutical market.

12Jun 25

Zydus Lifesciences Secures Top-Tier USFDA Approval for API Facility

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.

11Jun 25

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

Zydus Lifesciences received an Establishment Inspection Report with 'No Action Indicated' status from the US FDA for its API facility in Ankleshwar, Gujarat. The company reported Q4 financial results with revenue up 15.29% to ₹6,370.80 cr, EBITDA up 30% to ₹2,126.00 cr, and US formulation revenue up 24% to ₹3,130.70 cr. Net profit slightly decreased by 1% to ₹1,171.00 cr. EBITDA margin expanded to 32.60%.

11Jun 25

Zydus Lifesciences Secures Clean FDA Inspection for Ankleshwar API Plant

Zydus Lifesciences has received an Establishment Inspection Report (EIR) from the U.S. FDA for its Active Pharmaceutical Ingredient (API) manufacturing facility in Ankleshwar. The inspection concluded with a 'No Action Indicated' (NAI) status, the best possible outcome. This result signifies that no significant issues were found requiring regulatory intervention. The clean inspection enhances Zydus's regulatory standing, strengthens its position in the U.S. market, reinforces its quality assurance reputation, and ensures operational continuity at the facility.

10Jun 25

Zydus Lifesciences Secures FDA Approval for Largest API Facility

Zydus Lifesciences has received an Establishment Inspection Report (EIR) from the USFDA for its Dabhasa API facility, which is the company's largest. The inspection concluded with a Voluntary Action Indicated (VAI) classification, indicating minor objectionable conditions that don't require regulatory action. The Dabhasa plant, crucial for Zydus's pharmaceutical production, has now officially closed its inspection process, validating the company's compliance with Good Manufacturing Practices and potentially enhancing its ability to supply APIs for the U.S. market.

03Jun 25

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

Zydus Lifesciences is acquiring two biologics manufacturing facilities in California from Agenus Inc. for $75 million upfront, with potential additional $50 million based on future revenue milestones. This acquisition marks Zydus' entry into the global biologics Contract Development and Manufacturing Organization (CDMO) market. The deal includes an exclusive manufacturing partnership with Agenus and focuses on two Phase-3 ready immuno-oncology products. This strategic move provides Zydus with advanced manufacturing capabilities in the US and strengthens its position in the high-value biologics segment.

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.