Leflunomide Export Market Intelligence: India's 106 Suppliers Shipping to 63 Countries — TransData Nexus 2026

Q: Who are the top leflunomide exporters from India?

The top leflunomide exporters from India are: 1. ZYDUS LIFESCIENCES LIMITED — $4.4M (29.7% market share); 2. TORRENT PHARMACEUTICALS LTD — $2.5M (17.0% market share); 3. KUSUM HEALTHCARE PRIVATE LIMITED — $1.3M (9.0% market share); 4. EMCURE PHARMACEUTICALS LIMITED — $1.2M (7.8% market share); 5. ALEMBIC PHARMACEUTICALS LIMITED — $1.2M (7.8% market share). Together they account for 71.4% of India's total leflunomide export value.

Q: What is the total export value of leflunomide from India?

The total export value of leflunomide from India is $14.9M USD, recorded across 816 shipment transactions from 106 active exporters to 63 destination countries. The average shipment value is $18.2K.

Q: Which countries import leflunomide from India?

India exports leflunomide to 63 countries worldwide. The top importing countries are: UNITED STATES (40.5% share, $6.0M), MYANMAR (14.2% share, $2.1M), SRI LANKA (8.4% share, $1.2M), UNITED KINGDOM (5.2% share, $778.0K), CHILE (4.9% share, $732.8K). These five markets account for 73.2% of total export value.

Q: What is the HS code for leflunomide exports from India?

The primary HS code for leflunomide exports from India is 30049099. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) for tracking and reporting pharmaceutical trade flows.

Q: What is the average price of leflunomide exports from India?

The average unit price for leflunomide exports from India is $6.98 USD per unit, with prices ranging from $0.01 to $719.70 depending on formulation, packaging, and order volume. The total market is valued at $14.9M across 816 shipments.

Q: Which ports handle leflunomide exports from India?

The primary ports for leflunomide exports from India are DELHI AIR CARGO ACC (INDEL4) (15.4% of shipments), SAHAR AIR (12.0% of shipments), SAHAR AIR CARGO ACC (INBOM4) (10.8% of shipments), DELHI AIR (9.7% of shipments), NHAVA SHEVA SEA (INNSA1) (8.5% of shipments). These ports have dedicated pharmaceutical cargo infrastructure ensuring cold-chain and regulatory compliance during transit.

Q: Why is India a leading exporter of leflunomide?

India is one of the world's leading exporters of leflunomide due to its large base of 106 WHO-GMP and US FDA approved manufacturers, significantly lower production costs compared to Western markets, well-established API (Active Pharmaceutical Ingredient) supply chains, and strong government support for pharmaceutical exports through the Pharmaceuticals Export Promotion Council (Pharmexcil). India exports leflunomide to 63 countries, demonstrating 32% global market coverage.

Q: What certifications do Indian leflunomide exporters need?

Indian leflunomide exporters typically require WHO-GMP (Good Manufacturing Practice) certification for most regulated markets, US FDA approval for exports to the United States, EU GMP certification for European markets, and country-specific regulatory approvals for markets in Africa, Asia, and Latin America. Additional certifications may include ISO 9001, Schedule M compliance under Indian drug laws, and Free Sale Certificates issued by the Central Drugs Standard Control Organization (CDSCO).

Q: How many buyers import leflunomide from India?

There are 202 registered buyers importing leflunomide from India, spread across 63 countries. The repeat buyer rate is 53.0%, indicating strong long-term trade relationships and consistent product quality.

Q: What is the market share of the top leflunomide supplier from India?

ZYDUS LIFESCIENCES LIMITED is the leading leflunomide exporter from India with a market share of 29.7% and total export value of $4.4M across 75 shipments. The top 5 suppliers together control 71.4% of total export value.

Suresh Sormare

Leflunomide

India Pharmaceutical Trade Intelligence

$14.9M106 Suppliers63 CountriesHS 30049099

ExportsIndia → UNITED STATES40.5%India → MYANMAR14.2%

ImportsCANADA → India$9.9K GERMANY → India$8.0K

#1 Supplier: ZYDUS LIFESCIENCES #1 Buyer: EVERSANA LIFE

Leflunomide Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Leflunomide to the World

Between 2022 and 2026, India exported $14.9M worth of leflunomide across 816 verified shipments to 63 countries — covering 32% of world markets in the Immunosuppressants segment. The largest destination is UNITED STATES (40.5%). ZYDUS LIFESCIENCES LIMITED leads with a 29.7% share. All figures are drawn from Indian Customs (DGFT) shipping bill records spanning four years of trade activity.

Source: Indian Customs (DGFT)·Published March 2026·Updated March 2026·

Leflunomide export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Leflunomide export data snapshot — $14.9M · 106 exporters · 63 countriesTransData Nexus · Indian Customs Data

Top Leflunomide Exporters from India

106 active exporters · Ranked by export value

View all 106 →

Top Leflunomide Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	ZYDUS LIFESCIENCES LIMITED	$4.4M	75	1	29.7%
2	TORRENT PHARMACEUTICALS LTD

Top Countries Importing Leflunomide from India

63 destination markets · Ranked by import value

All 63 countries →

Top Countries Importing Leflunomide from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$6.0M	40.5%
2	MYANMAR	$2.1M	14.2%
3	SRI LANKA	$1.2M	8.4%
4	UNITED KINGDOM	$778.0K	5.2%
5	CHILE	$732.8K	4.9%
6	CANADA	$574.8K	3.9%
7	GERMANY	$566.9K	3.8%
8	KAZAKHSTAN	$401.5K	2.7%
9	UZBEKISTAN	$375.8K	2.5%
10	UKRAINE	$330.6K	2.2%

UNITED STATES is India's largest leflunomide export destination, absorbing 40.5% of total exports worth $6.0M. The top 5 importing countries — UNITED STATES, MYANMAR, SRI LANKA, UNITED KINGDOM, CHILE — together account for 73.2% of India's total leflunomide export value. The remaining 58 destination countries collectively receive the other 26.8%, indicating a broadly diversified export footprint across multiple regions.

Who Supplies Leflunomide to India?

8 origin countries · Total import value: $24.0K

India imports leflunomide from 8 countries with a combined import value of $24.0K. The largest supplier is CANADA ($9.9K, 15 shipments), followed by GERMANY and SINGAPORE. All values are from Indian Customs (DGFT) import records.

Countries Supplying Leflunomide to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	CANADA	$9.9K	15	41.4%
2	GERMANY	$8.0K	5	33.2%
3	SINGAPORE	$3.6K	1	15.1%
4	BULGARIA	$2.1K	2	8.7%
5	TURKEY	$303	2	1.3%
6	MALAYSIA	$64	2	0.3%
7	MALTA	$13	1	0.1%
8	UNITED STATES	$2	1	0.0%

CANADA is the largest supplier of leflunomide to India, accounting for 41.4% of total import value. The top 5 origin countries — CANADA, GERMANY, SINGAPORE, BULGARIA, TURKEY — together supply 99.7% of India's leflunomide imports. Click any country to see detailed supplier and buyer data for that import corridor.

Leflunomide — Export Intelligence Video

Visual overview of India's leflunomide import and export market — top suppliers, destinations, pricing, and trade routes

This video covers India's leflunomide pharmaceutical import and export market — $14.9M in total trade, 106 verified manufacturers, and 63 destination countries. Data sourced from Indian Customs (DGFT) shipment records.

Regulatory Landscape — Leflunomide

Product-specific regulatory status across FDA, EMA, WHO, and CDSCO · As of March 2026

1FDA & US Market Regulatory Status

In the United States, leflunomide received its initial approval under the brand name Arava on September 10, 1998, as documented in the FDA's Drug Approval Package. Subsequently, numerous Abbreviated New Drug Applications (ANDAs) for generic versions have been approved, reflecting a competitive market landscape. The FDA's Orange Book lists multiple approved ANDAs for leflunomide, indicating its widespread acceptance and availability in the U.S. market. Notably, the United States accounted for 40.5% of India's leflunomide exports between 2022 and 2026, underscoring the significance of the U.S. market for Indian exporters.

2EU & UK Regulatory Framework

In the European Union, leflunomide was first authorized under the brand name Arava on September 2, 1999, for the treatment of active rheumatoid arthritis and psoriatic arthritis. Generic versions, such as Leflunomide Teva, received marketing authorization on March 10, 2011. However, due to the absence of marketing within three years, Leflunomide Teva's authorization lapsed on March 10, 2014, in accordance with the EU's "sunset clause" provisions. Similarly, Repso, another generic version, had its marketing authorization withdrawn on July 19, 2017, at the request of the marketing authorization holder for commercial reasons. Despite these withdrawals, other generic versions like Leflunomide Zentiva remain authorized and available in the EU market. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) aligns with the EU's regulatory standards, ensuring that leflunomide products meet stringent quality and safety requirements.

3WHO Essential Medicines & Global Standards

Leflunomide is included in the World Health Organization's Model List of Essential Medicines, highlighting its importance in treating rheumatoid arthritis. The drug is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality parameters across different regions.

4India Regulatory Classification

In India, leflunomide is classified as a Schedule H drug under the Drugs and Cosmetics Act, necessitating a prescription for its dispensation. The National Pharmaceutical Pricing Authority (NPPA) oversees the pricing of essential medicines; however, as of March 2026, leflunomide is not listed under the Drugs (Prices Control) Order (DPCO), indicating no ceiling price is currently imposed. For export purposes, Indian manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations.

5Patent & Exclusivity Status

The primary patents for leflunomide have expired, leading to the availability of multiple generic versions globally. This has intensified competition among manufacturers, contributing to the drug's affordability and accessibility.

6Recent Industry Developments

In June 2025, the NPPA conducted a review of essential medicines pricing, but leflunomide remained outside the purview of price control, allowing market-driven pricing to continue. In September 2025, the FDA approved a new generic version of leflunomide, further enhancing market competition and potentially influencing export dynamics for Indian manufacturers. In December 2025, the EMA updated its guidelines on the manufacturing of active pharmaceutical ingredients (APIs), emphasizing stricter compliance with Good Manufacturing Practices (GMP), which Indian exporters must adhere to for continued access to the European market.

These developments underscore the dynamic regulatory environment surrounding leflunomide, necessitating continuous monitoring by stakeholders to ensure compliance and strategic market positioning.

TransData Nexus Research · FDA Orange Book, EMA, WHO Model List, CDSCO/NPPAUpdated Mar 2026

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Global Price Benchmark — Leflunomide

Retail & reference prices across 9 markets vs. India FOB export price of $6.98/unit

Global Price Benchmark for Leflunomide across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$5.00	USD	According to the FDA's Orange Book, Leflunomide is an approved generic medication, contributing to its competitive pricing in the U.S. market.
United Kingdom	$4.55	GBP	The NHS Drug Tariff lists Leflunomide, ensuring regulated pricing within the UK healthcare system.
Germany	$4.40	EUR	The Federal Institute for Drugs and Medical Devices (BfArM) oversees the pricing and availability of medications like Leflunomide in Germany.
Australia	$4.20

Supply Chain Risk Assessment — Leflunomide

API sourcing, concentration risk, storage requirements, and current alerts

MEDIUM RISK

1API Sourcing & Raw Material Dependency

Leflunomide, an immunomodulatory drug primarily used to treat rheumatoid arthritis, is predominantly manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) heavily relies on Key Starting Materials (KSMs) sourced from China. This dependency is part of a broader trend where India imports approximately 60–70% of its KSMs and intermediates from China, creating significant supply chain vulnerabilities.

Recent disruptions have underscored these risks. In July 2018, environmental regulations led to the shutdown of several Chinese chemical plants, causing a ripple effect that impacted global pharmaceutical supply chains, including Indian API manufacturers. Such events highlight the fragility of over-reliance on a single country for critical raw materials.

2Supplier Concentration & Single-Source Risk

The export market for Leflunomide from India is notably concentrated. The top five exporters—Zydus Lifesciences Limited, Torrent Pharmaceuticals Ltd, Kusum Healthcare Private Limited, Emcure Pharmaceuticals Limited, and Alembic Pharmaceuticals Limited—collectively account for 71.4% of total exports. Zydus Lifesciences Limited alone holds a 29.7% share, indicating a significant single-source risk.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at promoting domestic manufacturing of critical KSMs, Drug Intermediates (DIs), and APIs. As of December 2025, the scheme has led to the establishment of manufacturing capacities for 26 KSMs/APIs, resulting in cumulative sales of ₹2,315 crore and avoiding imports worth ₹1,807 crore.

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Frequently Asked Questions — Leflunomide Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top leflunomide exporters from India?

The leading leflunomide exporters from India are ZYDUS LIFESCIENCES LIMITED, TORRENT PHARMACEUTICALS LTD, KUSUM HEALTHCARE PRIVATE LIMITED, and 11 others. ZYDUS LIFESCIENCES LIMITED leads with 29.7% market share ($4.4M). The top 5 suppliers together control 71.4% of total export value.

What is the total export value of leflunomide from India?

The total export value of leflunomide from India is $14.9M, recorded across 816 shipments from 106 active exporters to 63 countries. The average shipment value is $18.2K.

Which countries import leflunomide from India?

India exports leflunomide to 63 countries. The top importing countries are UNITED STATES (40.5%), MYANMAR (14.2%), SRI LANKA (8.4%), UNITED KINGDOM (5.2%), CHILE (4.9%), which together account for 73.2% of total export value.

What is the HS code for leflunomide exports from India?

The primary HS code for leflunomide exports from India is 30049099. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) to track and report pharmaceutical export flows.

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Verified Author

Pharmaceutical 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/sureshsormare

Primary 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.

Leflunomide

Leflunomide

Top Leflunomide Exporters from India

Top Countries Importing Leflunomide from India

Who Supplies Leflunomide to India?

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Leflunomide — Export Intelligence Video

Regulatory Landscape — Leflunomide

1FDA & US Market Regulatory Status

2EU & UK Regulatory Framework

3WHO Essential Medicines & Global Standards

4India Regulatory Classification

5Patent & Exclusivity Status

6Recent Industry Developments

Global Price Benchmark — Leflunomide

Supply Chain Risk Assessment — Leflunomide

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Leflunomide Trade Intelligence

Frequently Asked Questions — Leflunomide Exports from India

Who are the top leflunomide exporters from India?

What is the total export value of leflunomide from India?

Which countries import leflunomide from India?

What is the HS code for leflunomide exports from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

India Cost Advantage

3Geopolitical & Shipping Disruptions

4Risk Mitigation Recommendations

What is the average price of leflunomide exports from India?

Which ports handle leflunomide exports from India?

Why is India a leading exporter of leflunomide?

What certifications do Indian leflunomide exporters need?

How many buyers import leflunomide from India?

What is the market share of the top leflunomide exporter from India?

Analysis Methodology