Zydus Lifesciences Limited (ZYDUSLIFE)
₹1,123.00 -1.51% last close, 16 Oct
Latest quarterly results (Q4 FY26)
In its latest reported quarter, Q4 FY26, Zydus Lifesciences' revenue was ₹7,587 Cr (+16.2% year on year, +10.5% on the previous quarter), and net profit ₹1,341 Cr (+14.5% year on year); the operating margin was 33.7%.
| Q4 FY26 (₹ Cr) | Value | YoY vs Q4 FY25 | QoQ |
|---|---|---|---|
| Revenue | ₹7,587 | +16.2% | +10.5% |
| Operating profit | ₹2,554 | +20.2% | +40.6% |
| Net profit | ₹1,341 | +14.5% | +31.1% |
| EPS (₹) | 12.65 | +8.7% | +22.1% |
| Operating margin | 33.7% | — | — |
ZYDUSLIFE delivery percentage and open interest
NSE end-of-day data for
On Fri, 16 Oct 2026, 65.1% of the ZYDUSLIFE shares traded on NSE were taken to delivery, against the stock's own 20-session average of 52.46%. The price fell 1.51% on that unusually high delivery, the pattern the delivery dashboard labels distribution. In ZYDUSLIFE futures, open interest rose 4.12% while the futures price fell 1.47%: short buildup (new short positions).
Delivery in the last 5 sessions: 53.7% · 51.3% · 54.8% · 50.2% · 65.1%
A description of what the exchange published, not a recommendation. Names such as "accumulation" or "long buildup" label a pattern in the numbers. How delivery is analysed
📢 Recent Corporate Announcements
Zydus Lifesciences' proposed joint venture, Zydus Sunshine Lifesciences (Pvt) Ltd, signed an agreement on October 13, 2026, with the Board of Investment of Sri Lanka to establish a manufacturing plant in Horana. The project involves a phased investment of over USD 20 million on a site spanning nearly four acres. In its initial phase, the plant will manufacture oral solid dosage forms specifically for the Sri Lankan market, with commercial operations slated to commence in 2028. Relative to Zydus Lifesciences' TTM revenue of ₹27,148 crore, the total capex of >$20 million (~₹165–170 crore) represents less than 1% of annual revenue, making it strategically relevant for regional footprint rather than financially material in the near term.
- Agreement signed on October 13, 2026, with the Board of Investment of Sri Lanka
- Project envisages a phased investment exceeding USD 20 million
- Facility to be built on a site of nearly 4 acres in the Horana BOI zone
- Commercial operations expected to commence in 2028
- Phase 1 will focus on oral solid dosage forms for Sri Lanka's domestic market
The USFDA conducted a regulatory inspection of Zydus Lifesciences' core manufacturing facility located at Moraiya, Ahmedabad, from October 5 to October 13, 2026. The inspection concluded with 5 observations issued under Form 483. The company stated that it will work closely with the USFDA to address the observations expeditiously. Moraiya is historically a critical facility for US-bound products, supporting Zydus's US generics footprint that underpins its TTM revenue of ₹27,148 crore.
- USFDA conducted an inspection of the Moraiya, Ahmedabad plant from 5th to 13th October 2026
- The regulatory audit concluded with 5 observations issued
- Company stated it will closely work with the USFDA to address observations expeditiously
- Moraiya facility remains a critical site supporting Zydus's ₹27,148 crore TTM revenue base
Zydus Lifesciences and partner Formycon announced that the USFDA has accepted the Biologics License Application (BLA) for review of FYB206, a biosimilar to Keytruda (pembrolizumab). Keytruda is the world's best-selling biologic with worldwide sales reaching USD 31.7 billion in 2025 and USD 16.40 billion in H1 2026. Zydus holds exclusive commercialization rights for the US and Canada and will pay a regulatory milestone payment to Formycon upon this acceptance. Under BsUFA timelines, a regulatory decision from the USFDA could be expected in Q3 2027.
- First publicly announced Keytruda biosimilar application accepted for review by the USFDA
- Reference product Keytruda generated USD 31.7 billion in global sales in 2025 and USD 16.40 billion in H1 2026
- Decision expected in Q3 2027 based on standard 12-month review under BsUFA
- Zydus holds exclusive commercialization rights in the US and Canada, sharing gross profits with Formycon
- Developed without a comparative Phase III trial via an agreed pathway with USFDA in early 2025
Zydus Lifesciences' subsidiary, Zydus Therapeutics, presented a post hoc analysis of the Phase 3 EPICS-III trial for Saroglitazar in primary biliary cholangitis (PBC) at the ACG 2026 meeting. The exploratory analysis showed composite biochemical response rates were higher for Saroglitazar versus placebo in both US (60.7% vs. 0%) and non-US subgroups (55.1% vs. 13.5%). The drug is currently under US FDA review, having received Priority Review, Fast Track, and Orphan Drug designations. If approved, Zydus plans to launch Saroglitazar in the United States by March 2027.
- Composite biochemical response rate reached 60.7% vs. 0% for placebo in the US subgroup (treatment difference of 60.7%)
- Non-US subgroup achieved a 55.1% response rate for Saroglitazar vs. 13.5% for placebo (treatment difference of 41.6%)
- Trial enrolled 148 patients randomized 2:1 between Saroglitazar magnesium 1 mg and placebo
- Targeted US commercial launch planned by March 2027, subject to FDA approval
Zydus Lifesciences Limited has submitted its quarterly compliance certificate under Regulation 74(5) of the SEBI (Depositories and Participants) Regulations, 2018 for the quarter ended September 30, 2026. The certificate from RTA MUFG Intime India confirms that share certificates received for dematerialisation have been verified, cancelled, and substituted with depositories. All corresponding securities continue to be listed on BSE and NSE. This is a standard quarterly administrative filing with no impact on business operations or financials.
- Compliance certificate submitted under Regulation 74(5) for the quarter ended September 30, 2026
- Issued based on confirmation from RTA MUFG Intime India Private Limited dated October 3, 2026
- Confirms mutilation and cancellation of dematerialised share certificates after due verification
- Filing verified and signed by Company Secretary on October 6, 2026
Zydus Lifesciences has partnered with MSN Laboratories to launch the first generic equivalent of Adempas (Riociguat Tablets) in the U.S. across all five strengths (0.5 mg to 2.5 mg). Riociguat was previously available only as a branded drug in the U.S., with originator Bayer reporting global Adempas sales of ~EUR 745 million (~USD 850 million) in 2025. The product is manufactured and developed by MSN, while Zydus leverages its U.S. commercial platform for distribution. This first-to-market advantage gives Zydus a significant near-term specialty generics opportunity relative to its TTM revenue of ₹27,148 crore.
- First generic launch of Adempas (riociguat tablets) in the U.S. market across all 5 strengths (0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg)
- Global sales of branded Adempas reported at ~EUR 745 million (~USD 850 million) in 2025 by innovator Bayer
- Product developed and manufactured by MSN Laboratories and commercialized by Zydus in the U.S.
- Indicated for chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH)
Zydus Lifesciences has extended the timeline for closing its 50% equity stake acquisition in Zydus Sunshine Lifesciences (Private) Limited. Originally agreed on June 26, 2026 with Sunshine Healthcare Lanka, the 50:50 joint venture is still completing condition precedents. Both parties signed an agreement on October 1, 2026, extending completion to December 2026. The financial transaction value was not disclosed in the filing.
- Target entity is Zydus Sunshine Lifesciences (Private) Limited to be formed as a 50:50 JV
- Partner is Sunshine Healthcare Lanka Limited under an SSSHA initially executed on June 26, 2026
- Extension letter executed on October 1, 2026 due to pending condition precedents
- Revised transaction completion date is set for December 2026
The USFDA conducted a cGMP inspection at Zydus Lifesciences' manufacturing facility located at SEZ II, Ahmedabad, from September 21 to September 28, 2026. The audit concluded with a single observation, and the company stated there were no data integrity-related observations. Zydus has committed to working closely with the USFDA to address this observation expeditiously. With TTM revenue of ₹19,316 Cr and US generics forming a primary growth driver, maintaining clean compliance at formulation sites is crucial to avoid approval bottlenecks.
- Inspection conducted by the USFDA between 21st and 28th September 2026
- Inspection concluded with 1 observation
- Company confirmed 0 data integrity-related issues
- Company commits to addressing the observation expeditiously
Zydus Lifesciences announced that the USFDA completed an onsite inspection of its pharmacovigilance and post-marketing surveillance system at its New Jersey, USA office. The audit was conducted between September 22 and September 25, 2026, and closed with zero Form 483 observations. This clean compliance check lowers regulatory risks surrounding post-marketing safety reporting for the company's US portfolio, which is a major contributor to its Rs 19,316 Cr TTM revenue base.
- USFDA conducted an onsite audit of the pharmacovigilance and post-marketing surveillance system.
- Inspection took place from 22nd September to 25th September 2026.
- Inspection closed with NIL observations (zero Form 483s issued).
- Audit pertained to the company's office located in New Jersey, USA.
CRISIL Ratings Limited has reviewed and reaffirmed Zydus Lifesciences' credit ratings across multiple bank facilities and debt instruments via letters dated September 10, 2026. The company's Rs 4,724 crore bank facilities retained 'CRISIL AAA/Stable' for long-term and 'CRISIL A1+' for short-term. Additionally, ratings for commercial papers (Rs 200 crore) and non-convertible debentures (totaling Rs 125 crore) were reaffirmed, though no CPs or NCDs are currently outstanding. This reaffirmation reflects the company's strong balance sheet profile, backed by a low debt-to-equity ratio of 0.31.
- CRISIL reaffirmed CRISIL AAA/Stable and CRISIL A1+ on Rs 4,724 crore bank facilities
- Commercial paper rating reaffirmed at CRISIL A1+ for Rs 200 crore facility
- Non-convertible debenture ratings reaffirmed at CRISIL AAA/Stable for Rs 50 crore and Rs 75 crore limits
- Company clarified there are zero outstanding Commercial Papers or NCDs as on date
Zydus Lifesciences Limited has announced its scheduled participation in the J.P. Morgan India Conference, 2026, set to take place on September 21, 2026. This is a routine institutional investor interaction disclosure pursuant to SEBI Listing Regulations. No material financial commitments, presentation materials, or operational updates were included in the filing.
- Participation scheduled for the J.P. Morgan India Conference, 2026
- Conference date fixed for September 21, 2026
- Filing submitted to BSE and NSE on September 11, 2026
Zydus Lifesciences' wholly owned US subsidiary, Zydus Pharmaceuticals USA Inc. (ZPUI), has entered into a settlement agreement with Indirect Reseller Plaintiffs in an ongoing generic pricing antitrust litigation. Under the settlement terms, ZPUI will pay USD 5.9 million (approx. ₹49–50 crore) for a full and final release of all claims by this class. The settlement was entered into without any admission of fault or wrongdoing. The financial payout is modest, representing less than 1.2% of the company's TTM Net Profit of ₹4,261 crore.
- ZPUI agreed to pay USD 5.9 million to resolve claims by Indirect Reseller Plaintiffs.
- Settlement pertains to MDL No. 2724 (Case No. 16-md-2724) pending in the US District Court for Eastern District of Pennsylvania.
- Includes a full and final release of all claims without any admission of fault or wrongdoing.
- Settlement cost is minimal relative to Zydus's TTM revenue of ₹19,316 crore.
Zydus Lifesciences has submitted the transcript of its 31st Annual General Meeting held on August 11, 2026. The management highlighted consolidated revenue of Rs 271.5 billion (growth of 17%) and an EBITDA margin of 31.2% for FY26. Key pipeline updates include the planned US launch of Saroglitazar in Q4 FY27 / FY28 under US FDA Priority Review and the ramp-up of Tishtha (nivolumab biosimilar), which reached over 25,000 patients within seven months. Management also reiterated comfortable leverage with debt below 1x EBITDA, targeting debt payoff within two years absent major M&A.
- FY26 consolidated revenue reached Rs 271.5 billion, reflecting a 17% YoY growth with a 31.2% EBITDA margin
- Saroglitazar (NCE) achieved ~17 million cumulative patient reach; US launch planned for Q4 FY27 under Priority Review
- Tishtha biosimilar reached over 25,000 cancer patients within 7 months of launch at ~70% lower cost vs reference drug
- Management noted debt sits at less than 1x EBITDA and expects to repay debt within two years without large acquisitions
Zydus Lifesciences announced positive topline results from its global Phase II(b) EVIDENCES-X clinical trial evaluating Saroglitazar Magnesium in Metabolic dysfunction Associated Steatohepatitis (MASH). The 52-week study enrolled 189 subjects across the US, Turkey, and Argentina, successfully meeting its primary endpoint of steatohepatitis resolution with no worsening of fibrosis at a treatment difference of 26.5%. While already approved by DCGI in India since 2020, the drug remains an investigational compound in the US and Europe.
- EVIDENCES-X Phase II(b) trial met primary endpoint of steatohepatitis resolution with no fibrosis worsening at week 52, showing a 26.5% treatment difference
- Trial enrolled 189 patients randomized 1:1:1 across Saroglitazar 2 mg, 4 mg, and placebo arms
- Study conducted across clinical sites in the USA, Turkey, and Argentina over a 52-week treatment duration
- Drug is approved in India (DCGI 2020) but remains investigational and unapproved by the US FDA and EMA
Zydus Lifesciences Limited has incorporated a wholly owned subsidiary, Zydus Global Treasury Centre IFSC Limited, in GIFT City, Gandhinagar on August 25, 2026. The subsidiary has an authorized and paid-up share capital of ₹5 crore, fully subscribed in cash. The entity is set up to function as a Global/Regional Corporate Treasury Centre to handle corporate treasury operations. Given Zydus Lifesciences' TTM revenue of ₹19,316 crore and net worth of ₹23,672 crore, this capital commitment is negligible and administrative.
- Incorporated wholly owned subsidiary 'Zydus Global Treasury Centre IFSC Limited' on August 25, 2026
- Authorized and paid-up share capital of ₹5 Crores subscribed 100% in cash
- Purpose is to operate as a Global and/or Regional Corporate Treasury Centre
- Subsidiary turnover is Nil as it is yet to commence operations
Financial Performance
Revenue Growth by Segment
Consolidated revenue grew 19% YoY in FY25 to INR 23,242 Cr. India Formulations achieved a 9.9% CAGR (FY23-25). US growth was driven by volume expansion in the base business and new product launches. International markets (Europe and Emerging Markets) witnessed high growth despite geopolitical challenges. H1 FY26 revenue reached INR 12,697 Cr, a 20% increase over H1 FY25.
Geographic Revenue Split
Domestic formulations accounted for 26% of total revenue in FY25 (INR 6,043 Cr). The US market is a primary driver, where the company ranks as a top 5 player by prescriptions. International markets including Europe and Emerging Markets contribute the remainder, with specific regional percentages not fully disclosed but noted for high growth momentum.
Profitability Margins
Adjusted PAT margin improved to 17.6% in FY25 from 16.5% in FY24. Adjusted PAT stood at INR 4,090 Cr in FY25 compared to INR 3,229 Cr in FY24. Operating profitability remained healthy at 30.9% in Q1 FY26, supported by a better business mix and stable input costs.
EBITDA Margin
Consolidated EBITDA margin was 30.4% in FY25 (INR 7,058.5 Cr), up from 27.5% in FY24. For H1 FY26, the EBITDA margin further expanded to 32.3% (INR 4,104.3 Cr). This 290-480 bps improvement is attributed to high-value therapy launches and operational efficiencies.
Capital Expenditure
Annual organic capital expenditure is planned at INR 900-1,200 Cr. In FY25, the company maintained a moderate capex profile while focusing on inorganic growth, such as the $75 million upfront payment for Agenus Inc.'s biologics facilities.
Credit Rating & Borrowing
CRISIL AAA/Stable for long-term facilities and CRISIL A1+ for short-term facilities. Interest coverage ratio was 49.7 times in FY25. Gross debt increased to INR 3,213 Cr as of March 31, 2025, from INR 804 Cr in FY24, primarily to fund working capital and the CCL acquisition.
Operational Drivers
Raw Materials
Active Pharmaceutical Ingredients (APIs) and bulk drugs are the primary raw materials, processed through 6 dedicated bulk drug manufacturing units. Specific chemical names and their individual cost percentages are not disclosed in the provided documents.
Import Sources
Not specifically disclosed, though the company operates a global supply chain with 31 manufacturing units across India and international locations.
Capacity Expansion
Current infrastructure includes 19 formulation units, 6 bulk drug units, 3 biologics units, 6 vaccine units, and 1 medical device facility. Expansion is focused on the MedTech space via the Amplitude Surgical acquisition and CDMO capabilities through the Agenus biologics facility acquisition.
Raw Material Costs
Raw material costs are described as 'stable,' contributing to the margin expansion to 30.4%. Procurement strategies involve internal manufacturing of APIs to ensure supply security and cost control.
Manufacturing Efficiency
The company maintains a low Lost Time Injury Frequency Rate (LTIFR) of 0.07. Efficiency is driven by a network of 31 specialized units allowing for scale in branded generics and wellness products.
Logistics & Distribution
The company utilizes a digital D2C (Direct-to-Consumer) model for its wellness segment following the acquisition of Comfort Click Ltd (CCL) to optimize international distribution in the UK and EU.
Strategic Growth
Expected Growth Rate
10-12%
Growth Strategy
Growth will be driven by a 10-12% annual revenue increase from new product launches in the US, a ramp-up in New Chemical Entities (NCEs) and biosimilars, and strategic acquisitions. Key moves include the £239 million acquisition of Comfort Click Ltd to enter the UK/EU wellness market and the $125 million Agenus deal to enter the global CDMO space and strengthen the oncology portfolio.
Products & Services
Branded generics, New Chemical Entities (NCEs), biosimilars, vaccines, wellness products (VMS - vitamins, minerals, and supplements), and medical devices (orthopedic implants).
Brand Portfolio
Pillar brands in cardio-diabetology, respiratory, and gynecology; wellness brands from the Heinz India acquisition (Glucon-D, Nycil); and new VMS brands via Comfort Click Ltd.
New Products/Services
Launch of immune-oncology assets (Botensilimab and Balstilimab) and expansion into the global CDMO sector. New product launches are expected to sustain double-digit growth.
Market Expansion
Targeting the UK, EU, and US wellness markets through CCL. Foraying into the global MedTech market via the acquisition of Amplitude Surgical (expected completion June 2025).
Market Share & Ranking
Top 5 player in the US generics market; leading positions in India for cardio-diabetology, respiratory, oncology, and nephrology.
Strategic Alliances
Operates through 4 Joint Ventures and 1 Associate. Includes a first-right-to-negotiate agreement with Agenus for manufacturing future developed products.
External Factors
Industry Trends
The industry is shifting toward specialty medicines, biosimilars, and digital D2C wellness. Zydus is positioning itself by acquiring digital-first players like CCL and investing in complex biologics to move away from simple generics.
Competitive Landscape
Faces intense competition in the US generics market from both Indian and global peers, leading to price erosion.
Competitive Moat
Moat is built on a strong domestic distribution network (26% of revenue) and a deep R&D pipeline in complex generics. Sustainability is supported by a net cash position of INR 3,100 Cr (Dec 2024) and annual cash accruals of ~INR 5,000 Cr.
Macro Economic Sensitivity
Sensitive to US healthcare pricing policies and Indian pharmaceutical price controls. Growth in international markets is sensitive to geopolitical stability in Europe.
Consumer Behavior
Increasing consumer demand for wellness and VMS products (Vitamins, Minerals, Supplements) globally, prompting the CCL acquisition.
Geopolitical Risks
Geopolitical challenges in certain emerging economies and Europe are noted as ongoing risks to the international formulations business.
Regulatory & Governance
Industry Regulations
Subject to US FDA manufacturing standards (CGMP). Past warning letters (Moraiya plant, 2019) demonstrate the high impact of regulatory compliance on market access.
Environmental Compliance
GHG emissions reduced by 3% in FY24. Waste intensity declined by 7%, with 61% of total waste recycled or co-processed.
Legal Contingencies
Zydus Pharmaceuticals (USA) Inc. is involved in complex legal proceedings including anti-trust matters, product liability, and employment claims. Specific case values are not disclosed but are handled by external legal counsel.
Risk Analysis
Key Uncertainties
Regulatory risks (US FDA inspections) and price erosion in the US market are the primary uncertainties. A net debt to EBITDA ratio above 0.5x is a rating sensitivity factor.
Geographic Concentration Risk
Significant revenue concentration in the US and India. The US market is particularly sensitive to regulatory and pricing shifts.
Third Party Dependencies
Dependency on third-party digital platforms for the newly acquired CCL business and clinical development partners for Agenus assets.
Technology Obsolescence Risk
Risk of being overtaken in the biologics/NCE space if R&D does not yield successful clinical outcomes. Digital transformation is evident in the CCL D2C acquisition.
Credit & Counterparty Risk
Liquidity is superior with INR 5,681 Cr in cash and equivalents as of March 2025, mitigating counterparty risk.
