Who Exports Leflunomide from India — 106 Suppliers Behind a $14.9M Market
India's leflunomide export market is supplied by 106 active exporters who collectively shipped $14.9M across 816 shipments. ZYDUS LIFESCIENCES LIMITED leads with a 29.7% market share, followed by TORRENT PHARMACEUTICALS LTD and KUSUM HEALTHCARE PRIVATE LIMITED. The top 5 suppliers together control 71.4% of total export value, reflecting a concentrated market structure.
Top Leflunomide Exporters from India — Ranked by Export Value
ZYDUS LIFESCIENCES LIMITED is the leading leflunomide exporter from India, holding a 29.7% share of the $14.9M market across 816 shipments from 106 exporters. The top 5 suppliers — ZYDUS LIFESCIENCES LIMITED, TORRENT PHARMACEUTICALS LTD, KUSUM HEALTHCARE PRIVATE LIMITED, EMCURE PHARMACEUTICALS LIMITED, ALEMBIC PHARMACEUTICALS LIMITED — collectively control 71.4% of total export value, indicating a highly concentrated market. Individual shares are: ZYDUS LIFESCIENCES LIMITED (29.7%), TORRENT PHARMACEUTICALS LTD (17.0%), KUSUM HEALTHCARE PRIVATE LIMITED (9.0%), EMCURE PHARMACEUTICALS LIMITED (7.8%), ALEMBIC PHARMACEUTICALS LIMITED (7.8%).
Top Leflunomide Exporters from India
Ranked by export value · 106 active suppliers · Indian Customs (DGFT) data
| # | Supplier & Formulations | Value | Ctry. | Share |
|---|---|---|---|---|
| 1 | ZYDUS LIFESCIENCES LIMITED LEFLUNOMIDE TABS USP 20MG 1X30 PACKS)LEFLUNOMIDE TAB 20MG X 30'S USLEFLUNOMIDE TABLETS USP 20MG [62640 PACK | $4.4M | 1 | 29.7% |
| 2 | TORRENT PHARMACEUTICALS LTD LEFRA 10 TABLET(LEFLUNLEFRA 20 TABLET LEFLUNOMIDE 20MG NOS=1X5X10 TABOTHERS : LEFRA 20 TABLET - PACK SIZE 1X5X10 TABS | $2.5M | 8 | 17.0% |
| 3 | KUSUM HEALTHCARE PRIVATE LIMITED LEFRA 20 TABLET LEFLUNOMIDE 20MG NOS=1X5X10 TABOTHERS : LEFRA 20 TABLET - PACK SIZE 1X5X10 TABSLEFNO-20 TABLETS 3X10S(LEFLUNOMIDE 20MG | $1.3M | 9 | 9.0% |
| 4 | EMCURE PHARMACEUTICALS LIMITED LEFLUNOMIDE TABS USP 20MG 1X30 PACKS)LEFLUNOMIDE TAB 20MG X 30'S USLEFLUNOMIDE TABLETS USP 20MG [62640 PACK | $1.2M | 7 | 7.8% |
| 5 | ALEMBIC PHARMACEUTICALS LIMITED LEFLUNOMIDE TABS USP 20MG 1X30 PACKS)LEFLUNOMIDE TAB 20MG X 30'S USLEFLUNOMIDE TABLETS USP 20MG [62640 PACK | $1.2M | 6 | 7.8% |
| 6 | CADILA HEALTHCARE LIMITED LEFLUNOMIDE TABS USP 20MG 1X30 PACKS)LEFLUNOMIDE TAB 20MG X 30'S USLEFLUNOMIDE TABLETS USP 20MG [62640 PACK | $699.9K | 1 | 4.7% |
| 7 | CIPLA LIMITED LEFLUNOMIDE TABLET 20MGLEFLUNOMIDE TABLET 20MG [PAC SIZE:1X4000 | $662.0K | 2 | 4.5% |
| 8 | TORRENT PHARMACEUTICALS LIMITED LEFRA 10 TABLET(LEFLUNLEFRA 20 TABLET LEFLUNOMIDE 20MG NOS=1X5X10 TABOTHERS : LEFRA 20 TABLET - PACK SIZE 1X5X10 TABS | $639.4K | 5 | 4.3% |
| 9 | LUPIN LIMITED LEFLUNOMIDE TABS USP 20MG 1X30 PACKS)LEFLUNOMIDE TAB 20MG X 30'S USLEFLUNOMIDE TABLETS USP 20MG [62640 PACK | $372.8K | 1 | 2.5% |
| 10 | MARKSANS PHARMA LIMITED PHARMACEUTICAL PRODUCTS - LEFLUNOMIDE 10MG TABLETSPHARMACEUTICAL PRODUCTS-LEFLUNOMIDE 10MGLEFLUNOMIDE 20MG TABLETS- 3 X 10 TAB (EA | $284.3K | 1 | 1.9% |
| 11 | CAPLIN POINT LABORATORIES LIMITED | $261.0K | 2 | 1.8% |
| 12 | EMCURE PHARMACEUTICALS LTD LEFLUNOMIDE TABS USP 20MG 1X30 PACKS)LEFLUNOMIDE TAB 20MG X 30'S USLEFLUNOMIDE TABLETS USP 20MG [62640 PACK | $161.0K | 2 | 1.1% |
| 13 | APL HEALTHCARE LIMITED LEFLUNOMIDE TABS USP 20MG 1X30 PACKS)LEFLUNOMIDE TAB 20MG X 30'S USLEFLUNOMIDE TABLETS USP 20MG [62640 PACK | $151.8K | 2 | 1.0% |
| 14 | TITAN LABORATORIES PRIVATE LIMITED | $105.6K | 2 | 0.7% |
Related Analysis
Supplier Certification & Compliance Matrix
FDA, WHO-GMP, and EU GMP status for top Leflunomide exporters
| Supplier | US FDA | WHO-GMP | EU GMP | ANDAs | Notes |
|---|---|---|---|---|---|
| Zydus Lifesciences Limited | Approved | Yes | Yes | Multiple | Formerly Cadila Healthcare; received USFDA approval for enzalutamide tablets in |
| Emcure Pharmaceuticals Limited | Warning Letter (August 20 | Yes | Yes | Multiple | Received USFDA warning letter for Hinjawadi facility in August 2019. |
| Torrent Pharmaceuticals Limited | Approved | Yes | Yes | Multiple | Acquired Heumann Pharma Generics GmbH in 2005; operates in over 40 countries. |
| Alembic Pharmaceuticals Limited | Approved | Yes | Yes | 223 (as of August 2025) | Received multiple USFDA approvals between 2024 and 2025, including for oncology |
| Cadila Pharmaceuticals Limited | Warning Letter (March 201 | Yes | Yes | Multiple | Received USFDA warning letter for Ankleshwar facility in March 2014. |
| Cipla Limited | Approved | Yes | Yes | Multiple | Received multiple USFDA approvals; operates in over 80 countries. |
| Lupin Limited | Approved | Yes | Yes | Multiple | Received multiple USFDA approvals; operates in over 100 countries. |
| Marksans Pharma Limited | Approved | Yes | Yes | Multiple | Received multiple USFDA approvals; operates in over 50 countries. |
| Caplin Point Laboratories Limited | Approved | Yes | Yes | Multiple | Received multiple USFDA approvals; operates in over 40 countries. |
| APL Healthcare Limited | Approved | Yes | Yes | Multiple | Received multiple USFDA approvals; operates in over 30 countries. |
TransData Nexus reviewed the regulatory standing of 10 leading Leflunomide exporters from India. 8 hold US FDA facility approvals, 10 maintain WHO-GMP certification, and 10 are EU GMP compliant. 2 suppliers have received FDA regulatory actions — buyers should verify current remediation status before placing orders. For regulated markets (US, EU, Australia), prioritise suppliers with active FDA or EU GMP approvals. For semi-regulated markets (Africa, ASEAN, Latin America), WHO-GMP certification is the minimum recommended standard.
Certification status compiled from publicly available regulatory databases including FDA Orange Book, WHO Prequalification database, and EMA GMP registry. Buyers should independently verify compliance status with the relevant regulatory authority before placing orders.
TransData Nexus Research · Mar 2026
Manufacturing Hub Analysis — Vendor Proximity
India's pharmaceutical clusters relevant to Leflunomide sourcing
1Hyderabad — Bulk Drug Capital
Hyderabad, often referred to as the "Bulk Drug Capital of India," hosts numerous pharmaceutical companies specializing in active pharmaceutical ingredients (APIs). The city's well-established infrastructure and supportive regulatory environment make it a strategic location for API production. Companies like Rakshit Pharmaceuticals, with cGMP-compliant facilities in Andhra Pradesh and Telangana, contribute significantly to the API supply chain, including Leflunomide.
2Ahmedabad-Vadodara — Formulations Hub
The Ahmedabad-Vadodara corridor in Gujarat is renowned for its pharmaceutical formulations industry. Alembic Pharmaceuticals, headquartered in Vadodara, exemplifies this with its extensive range of pharmaceutical products, including Leflunomide formulations. The region's focus on formulations complements the API production in other clusters, ensuring a seamless supply chain from raw materials to finished products.
3Mumbai-Thane-Raigad — Export Gateway
The Mumbai-Thane-Raigad belt serves as a critical export gateway for pharmaceutical products. Proximity to major ports like Nhava Sheva facilitates efficient international distribution. Companies in this region leverage the logistical advantages to export formulations, including Leflunomide, to global markets. For instance, Lupin Limited, headquartered in Mumbai, has received FDA approval for its Leflunomide Tablets USP, manufactured at its Pithampur facility, and utilizes Mumbai's ports for distribution.
4Baddi-Nalagarh — Tax Incentive Zone
Baddi-Nalagarh in Himachal Pradesh has emerged as a pharmaceutical manufacturing hub, driven by favorable tax incentives and supportive policies. The region attracts numerous pharmaceutical companies focusing on cost-effective production of both APIs and formulations. This cluster enhances the overall supply chain by providing competitive manufacturing options for drugs like Leflunomide.
5Sourcing Recommendations
- Diversify Supplier Base: Engage with multiple suppliers across different clusters to mitigate risks associated with regional disruptions.
- Leverage API and Formulation Synergies: Collaborate with companies in Hyderabad for API procurement and those in Ahmedabad-Vadodara for formulations to optimize the supply chain.
- Utilize Export Infrastructure: Capitalize on the logistical advantages of the Mumbai-Thane-Raigad region for efficient international distribution.
- Consider Cost-Effective Manufacturing: Explore partnerships in the Baddi-Nalagarh cluster to benefit from cost-effective production facilitated by tax incentives.
Recent M&A, Collaborations & Capacity Expansions
Industry developments among top Leflunomide exporters from India
Torrent Pharmaceuticals Ltd — Torrent Pharmaceuticals acquires Curatio Healthcare for ₹2,000 crores
In September 2022, Torrent Pharmaceuticals Ltd acquired 100% of Curatio Healthcare, a skincare product manufacturer, for ₹2,000 crores. - IMPACT: This acquisition is expected to diversify Torrent's product portfolio; however, no direct impact on Leflunomide exports is anticipated.
Impact: This acquisition is expected to diversify Torrent's product portfolio; however, no direct impact on Leflunomide exports is anticipated.
Common Questions — Leflunomide Suppliers from India
Answers based on Indian Customs (DGFT) shipment records compiled by TransData Nexus
Q Which leflunomide supplier from India is the most reliable for bulk orders?
Based on shipment frequency and export consistency, ZYDUS LIFESCIENCES LIMITED leads with 75 recorded shipments worth $4.4M. TORRENT PHARMACEUTICALS LTD (45 shipments) and KUSUM HEALTHCARE PRIVATE LIMITED (56 shipments) are also established high-volume exporters.
Q How many leflunomide manufacturers are there in India?
India has 106 active leflunomide exporters with a combined export market of $14.9M across 816 shipments to 63 countries. The top 5 suppliers hold 71.4% of total export value.
Q What certifications should I verify?
Verify: WHO-GMP certification (most markets), US FDA approval (United States), EU GMP certificate (EU/EEA), and Free Sale Certificate from CDSCO. Always request a Certificate of Analysis (CoA) and Certificate of Origin (CoO).
Q What is the typical price range for leflunomide from India?
Average FOB unit price: $6.98 per unit, ranging from $0.01 to $719.70. Average shipment value: $18.2K.
Official References & Regulatory Resources
- CDSCO India
- Pharmexcil
- IBEF — India Pharma Industry
- Ministry of Commerce — Pharma Exports
- India Trade Statistics (DGFT)
Verify manufacturer licensing and export certifications with the official agencies above.
Research Methodology & Data Transparency
Suresh Sormare
Verified AuthorPharmaceutical Export-Import Analyst & Trade Intelligence Expert
Suresh Sormare is a pharmaceutical export-import analyst with deep expertise in Indian Customs (DGFT) data, HS code classification, and global pharmaceutical supply chains. His analysis covers 10M+ shipment records across 150+ countries and is used by manufacturers, procurement agencies, and trade consultants worldwide. Suresh specializes in identifying verified suppliers and buyers from customs records, mapping bilateral pharmaceutical trade corridors, analyzing tariff structures and regulatory frameworks across 170+ destination markets, and benchmarking competitive positioning for finished pharmaceutical formulations. His methodology combines granular customs transaction data with regulatory intelligence from FDA, EMA, WHO, CDSCO, and 40+ national drug authorities to deliver actionable trade insights for the pharmaceutical formulations sector.
linkedin.com/in/sureshsormarePrimary Data Source
All trade data is sourced from Indian Customs (DGFT) official shipping bill records — the authoritative government database for India's pharmaceutical trade. Each verified record contains exporter name, consignee (buyer) name, detailed product description, quantity, declared FOB value (USD), port of loading, destination country, and shipment date.
Analysis Methodology
- 1.Supplier Ranking: 106 verified Indian exporters of Leflunomide ranked by capped export value from DGFT shipping bill records.
- 2.Export Value Analysis: Total export value aggregated from 816 individual shipping bill records. Values are FOB in USD.
- 3.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation.
- 4.Market Concentration: Supplier market share and geographic reach analyzed across 63 destination countries.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
816 Verified Shipments
106 exporters tracked
Expert-Reviewed
By pharmaceutical trade specialists