Irinotecan Export Market Intelligence: India's 164 Suppliers Shipping to 111 Countries — TransData Nexus 2026

Q: Who are the top irinotecan exporters from India?

The top irinotecan exporters from India are: 1. INTAS PHARMACEUTICALS LIMITED — $14.7M (35.8% market share); 2. FRESENIUS KABI ONCOLOGY LIMITED — $10.4M (25.4% market share); 3. EUGIA PHARMA SPECIALITIES LIMITED — $5.7M (13.8% market share); 4. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $3.1M (7.6% market share); 5. VENUS REMEDIES LIMITED — $1.3M (3.1% market share). Together they account for 85.6% of India's total irinotecan export value.

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

The total export value of irinotecan from India is $41.1M USD, recorded across 2,905 shipment transactions from 164 active exporters to 111 destination countries. The average shipment value is $14.2K.

Q: Which countries import irinotecan from India?

India exports irinotecan to 111 countries worldwide. The top importing countries are: GERMANY (19.7% share, $8.1M), POLAND (10.7% share, $4.4M), NETHERLANDS (8.3% share, $3.4M), BELGIUM (7.3% share, $3.0M), CANADA (7.1% share, $2.9M). These five markets account for 53.0% of total export value.

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

The primary HS code for irinotecan exports from India is 30049049. 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 irinotecan exports from India?

The average unit price for irinotecan exports from India is $110.05 USD per unit, with prices ranging from $0.00 to $68872.18 depending on formulation, packaging, and order volume. The total market is valued at $41.1M across 2,905 shipments.

Q: Which ports handle irinotecan exports from India?

The primary ports for irinotecan exports from India are DELHI AIR CARGO ACC (INDEL4) (10.3% of shipments), SAHAR AIR (10.2% of shipments), AHEMDABAD AIR ACC (INAMD4) (8.7% of shipments), MUNDRA SEA (INMUN1) (7.5% of shipments), SAHAR AIR CARGO ACC (INBOM4) (7.1% 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 irinotecan?

India is one of the world's leading exporters of irinotecan due to its large base of 164 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 irinotecan to 111 countries, demonstrating 57% global market coverage.

Q: What certifications do Indian irinotecan exporters need?

Indian irinotecan 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 irinotecan from India?

There are 495 registered buyers importing irinotecan from India, spread across 111 countries. The repeat buyer rate is 57.8%, indicating strong long-term trade relationships and consistent product quality.

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

INTAS PHARMACEUTICALS LIMITED is the leading irinotecan exporter from India with a market share of 35.8% and total export value of $14.7M across 1099 shipments. The top 5 suppliers together control 85.6% of total export value.

Suresh Sormare

Irinotecan

India Pharmaceutical Trade Intelligence

$41.1M164 Suppliers111 CountriesHS 30049049

ExportsIndia → GERMANY19.7%India → POLAND10.7%

ImportsAUSTRALIA → India$78.4M FRANCE → India$17.9M

#1 Supplier: INTAS PHARMACEUTICALS #1 Buyer: FRESENIUS KABI

Irinotecan Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Irinotecan to the World

Between 2022 and 2026, India exported $41.1M worth of irinotecan across 2,905 verified shipments to 111 countries — covering 57% of world markets in the Oncology segment. The largest destination is GERMANY (19.7%). INTAS PHARMACEUTICALS LIMITED leads with a 35.8% 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·HS 30049049

Irinotecan export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Irinotecan export data snapshot — $41.1M · 164 exporters · 111 countriesTransData Nexus · Indian Customs Data

Top Irinotecan Exporters from India

164 active exporters · Ranked by export value

View all 164 →

Top Irinotecan Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	INTAS PHARMACEUTICALS LIMITED	$14.7M	1,099	20	35.8%
2	FRESENIUS KABI ONCOLOGY LIMITED

Top Countries Importing Irinotecan from India

111 destination markets · Ranked by import value

All 111 countries →

Top Countries Importing Irinotecan from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	GERMANY	$8.1M	19.7%
2	POLAND	$4.4M	10.7%
3	NETHERLANDS	$3.4M	8.3%
4	BELGIUM	$3.0M	7.3%
5	CANADA	$2.9M	7.1%
6	UNITED STATES	$2.8M	6.8%
7	UNITED KINGDOM	$1.4M	3.5%
8	ALGERIA	$1.2M	3.0%
9	SOUTH AFRICA	$1.2M	2.8%
10	AUSTRALIA	$1.1M	2.8%

GERMANY is India's largest irinotecan export destination, absorbing 19.7% of total exports worth $8.1M. The top 5 importing countries — GERMANY, POLAND, NETHERLANDS, BELGIUM, CANADA — together account for 53.0% of India's total irinotecan export value. The remaining 106 destination countries collectively receive the other 47.0%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Irinotecan to India?

10 origin countries · Total import value: $97.0M

India imports irinotecan from 10 countries with a combined import value of $97.0M. The largest supplier is AUSTRALIA ($78.4M, 7 shipments), followed by FRANCE and UNITED STATES. All values are from Indian Customs (DGFT) import records.

Countries Supplying Irinotecan to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	AUSTRALIA	$78.4M	7	80.8%
2	FRANCE	$17.9M	5	18.5%
3	UNITED STATES	$701.0K	17	0.7%
4	GERMANY	$12.9K	1	0.0%
5	IRELAND	$10.4K	2	0.0%
6	FINLAND	$6.4K	1	0.0%
7	AUSTRIA	$2.3K	1	0.0%
8	UNITED KINGDOM	$1.6K	3	0.0%
9	RUSSIA	$157	1	0.0%
10	THAILAND	$80	2	0.0%

AUSTRALIA is the largest supplier of irinotecan to India, accounting for 80.8% of total import value. The top 5 origin countries — AUSTRALIA, FRANCE, UNITED STATES, GERMANY, IRELAND — together supply 100.0% of India's irinotecan imports. Click any country to see detailed supplier and buyer data for that import corridor.

Irinotecan — Export Intelligence Video

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

This video covers India's irinotecan pharmaceutical import and export market — $41.1M in total trade, 164 verified manufacturers, and 111 destination countries. Data sourced from Indian Customs (DGFT) shipment records.

Regulatory Landscape — Irinotecan

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

1FDA & US Market Regulatory Status

Irinotecan has been a pivotal component in the U.S. oncology pharmacopeia, with numerous Abbreviated New Drug Applications (ANDAs) approved by the FDA, facilitating the availability of generic formulations. The FDA's Orange Book lists multiple approved ANDAs for irinotecan, underscoring its established presence in the market. The regulatory pathway for irinotecan involves stringent compliance with FDA guidelines, including adherence to Current Good Manufacturing Practices (cGMP) and successful demonstration of bioequivalence to the reference listed drug. Notably, there have been no recent import alerts or significant regulatory actions against Indian exporters of irinotecan, indicating consistent compliance with U.S. regulatory standards. Given the presence of 164 active Indian exporters, maintaining rigorous quality control and regulatory compliance is imperative to sustain and expand market share in the U.S.

2EU & UK Regulatory Framework

In the European Union, irinotecan is subject to the European Medicines Agency's (EMA) centralized marketing authorization process or national procedures within member states. The EMA has conducted periodic safety update report single assessments (PSUSAs) for irinotecan, with notable assessments in March 2018 and March 2021, leading to variations in product information to enhance safety and efficacy profiles. (ema.europa.eu) The UK's Medicines and Healthcare products Regulatory Agency (MHRA) aligns closely with EMA standards, ensuring that irinotecan products meet stringent safety, efficacy, and quality requirements. Compliance with EU Good Manufacturing Practice (GMP) guidelines is mandatory for manufacturers, necessitating regular inspections and certifications to ensure product quality and safety.

3WHO Essential Medicines & Global Standards

Irinotecan is included in the World Health Organization's (WHO) Model List of Essential Medicines, reflecting its critical role in cancer treatment. This inclusion underscores the global recognition of irinotecan's therapeutic importance and guides national health policies in ensuring its availability. Manufacturers are expected to comply with international pharmacopoeia standards, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to ensure consistent quality and efficacy across different markets.

4India Regulatory Classification

In India, irinotecan is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, as of March 2026, irinotecan is not listed under the Drug Price Control Order (DPCO), allowing manufacturers to set prices based on market dynamics. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure that domestic supply is not adversely affected by international demand.

5Patent & Exclusivity Status

The primary patents for irinotecan have expired, leading to a competitive generic market with multiple manufacturers producing the drug. This generic competition has contributed to the widespread availability and affordability of irinotecan globally.

6Recent Industry Developments

In March 2025, the EMA granted orphan designation to irinotecan hydrochloride trihydrate for the treatment of small cell lung cancer, recognizing its potential benefit in addressing this rare condition. (ema.europa.eu) In December 2025, the FDA designated 7-ethyl-10-hydroxycamptothecin and irinotecan for the treatment of stomach cancer, including gastroesophageal junction cancer, as an orphan drug, highlighting its significance in treating these malignancies. Additionally, in February 2026, the FDA approved LONSURF (trifluridine/tipiracil) for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma, a regimen that includes irinotecan, reflecting ongoing advancements in combination therapies.

These developments underscore the dynamic regulatory landscape surrounding irinotecan, emphasizing the need for manufacturers and exporters to stay abreast of evolving standards and approvals to maintain compliance and market competitiveness.

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

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Global Price Benchmark — Irinotecan

Retail & reference prices across 9 markets vs. India FOB export price of $110.05/unit

Global Price Benchmark for Irinotecan across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$1,200	USD	According to the FDA's Orange Book, Irinotecan is approved for use in the United States.
United Kingdom	$1,170	GBP	As per the NHS Drug Tariff, Irinotecan is listed for use within the National Health Service.
Germany	$1,100	EUR	The European Medicines Agency (EMA) has authorized the use of Irinotecan in Germany.
Australia	$1,050	AUD

Supply Chain Risk Assessment — Irinotecan

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Irinotecan, a critical chemotherapy agent, 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 approximately 41% of KSMs used in U.S.-approved APIs are solely sourced from China, and 16% from India, as reported by the U.S. Pharmacopeia in November 2025.

Recent geopolitical tensions have exacerbated this vulnerability. In February 2026, the closure of the Strait of Hormuz disrupted the supply of naphtha, a vital feedstock for chemical production, leading to force majeure declarations and production cutbacks in Asia's chemical industry. Such disruptions highlight the fragility of supply chains dependent on specific regions for essential raw materials.

2Supplier Concentration & Single-Source Risk

The export market for irinotecan from India is highly concentrated, with the top five exporters—Intas Pharmaceuticals Limited, Fresenius Kabi Oncology Limited, Eugia Pharma Specialities Limited, Sun Pharmaceutical Industries Limited, and Venus Remedies Limited—accounting for 85.6% of total exports. Notably, Intas Pharmaceuticals Limited alone holds a 35.8% share. This concentration poses a significant risk, as any operational or regulatory issues affecting these key suppliers could disrupt global supply chains.

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Frequently Asked Questions — Irinotecan Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top irinotecan exporters from India?

The leading irinotecan exporters from India are INTAS PHARMACEUTICALS LIMITED, FRESENIUS KABI ONCOLOGY LIMITED, EUGIA PHARMA SPECIALITIES LIMITED, and 11 others. INTAS PHARMACEUTICALS LIMITED leads with 35.8% market share ($14.7M). The top 5 suppliers together control 85.6% of total export value.

What is the total export value of irinotecan from India?

The total export value of irinotecan from India is $41.1M, recorded across 2,905 shipments from 164 active exporters to 111 countries. The average shipment value is $14.2K.

Which countries import irinotecan from India?

India exports irinotecan to 111 countries. The top importing countries are GERMANY (19.7%), POLAND (10.7%), NETHERLANDS (8.3%), BELGIUM (7.3%), CANADA (7.1%), which together account for 53.0% of total export value.

What is the HS code for irinotecan exports from India?

The primary HS code for irinotecan exports from India is 30049049. 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.

Irinotecan

Irinotecan

Top Irinotecan Exporters from India

Top Countries Importing Irinotecan from India

Who Supplies Irinotecan to India?

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Irinotecan — Export Intelligence Video

Regulatory Landscape — Irinotecan

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 — Irinotecan

Supply Chain Risk Assessment — Irinotecan

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Irinotecan Trade Intelligence

Frequently Asked Questions — Irinotecan Exports from India

Who are the top irinotecan exporters from India?

What is the total export value of irinotecan from India?

Which countries import irinotecan from India?

What is the HS code for irinotecan 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 irinotecan exports from India?

Which ports handle irinotecan exports from India?

Why is India a leading exporter of irinotecan?

What certifications do Indian irinotecan exporters need?

How many buyers import irinotecan from India?

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

Analysis Methodology