Fluorouracil Export Market Intelligence: India's 231 Suppliers Shipping to 130 Countries — TransData Nexus 2026

Q: Who are the top fluorouracil exporters from India?

The top fluorouracil exporters from India are: 1. INTAS PHARMACEUTICALS LIMITED — $3.2M (26.4% market share); 2. ALEMBIC PHARMACEUTICALS LIMITED — $3.1M (25.0% market share); 3. NAPROD LIFE SCIENCES PRIVATE LIMITED — $1.7M (13.7% market share); 4. GLAND PHARMA LIMITED — $1.1M (9.0% market share); 5. NV REMEDIES PRIVATE LIMITED — $508.8K (4.1% market share). Together they account for 78.3% of India's total fluorouracil export value.

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

The total export value of fluorouracil from India is $12.3M USD, recorded across 2,093 shipment transactions from 231 active exporters to 130 destination countries. The average shipment value is $5.9K.

Q: Which countries import fluorouracil from India?

India exports fluorouracil to 130 countries worldwide. The top importing countries are: UNITED STATES (49.4% share, $6.1M), COLOMBIA (6.8% share, $836.4K), MOROCCO (4.2% share, $510.0K), UKRAINE (3.7% share, $453.2K), THAILAND (3.5% share, $430.8K). These five markets account for 67.5% of total export value.

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

The primary HS code for fluorouracil exports from India is 30049042. 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 fluorouracil exports from India?

The average unit price for fluorouracil exports from India is $2.69 USD per unit, with prices ranging from $0.00 to $1374.41 depending on formulation, packaging, and order volume. The total market is valued at $12.3M across 2,093 shipments.

Q: Which ports handle fluorouracil exports from India?

The primary ports for fluorouracil exports from India are SAHAR AIR (18.3% of shipments), SAHAR AIR CARGO ACC (INBOM4) (16.9% of shipments), DELHI AIR CARGO ACC (INDEL4) (16.5% of shipments), DELHI AIR (10.8% of shipments), Bombay Air (4.9% 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 fluorouracil?

India is one of the world's leading exporters of fluorouracil due to its large base of 231 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 fluorouracil to 130 countries, demonstrating 67% global market coverage.

Q: What certifications do Indian fluorouracil exporters need?

Indian fluorouracil 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 fluorouracil from India?

There are 473 registered buyers importing fluorouracil from India, spread across 130 countries. The repeat buyer rate is 51.6%, indicating strong long-term trade relationships and consistent product quality.

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

INTAS PHARMACEUTICALS LIMITED is the leading fluorouracil exporter from India with a market share of 26.4% and total export value of $3.2M across 163 shipments. The top 5 suppliers together control 78.3% of total export value.

Suresh Sormare

Fluorouracil

India Pharmaceutical Trade Intelligence

$12.3M231 Suppliers130 CountriesHS 30049042

ExportsIndia → UNITED STATES49.4%India → COLOMBIA6.8%

ImportsUNITED STATES → India$9.3K SWITZERLAND → India$983

#1 Supplier: INTAS PHARMACEUTICALS #1 Buyer: J. KNIPPER

Fluorouracil Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Fluorouracil to the World

Between 2022 and 2026, India exported $12.3M worth of fluorouracil across 2,093 verified shipments to 130 countries — covering 67% of world markets in the Oncology segment. The largest destination is UNITED STATES (49.4%). INTAS PHARMACEUTICALS LIMITED leads with a 26.4% 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 30049042

Fluorouracil export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Fluorouracil export data snapshot — $12.3M · 231 exporters · 130 countriesTransData Nexus · Indian Customs Data

Top Fluorouracil Exporters from India

231 active exporters · Ranked by export value

View all 231 →

Top Fluorouracil Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	INTAS PHARMACEUTICALS LIMITED	$3.2M	163	14	26.4%
2	ALEMBIC PHARMACEUTICALS LIMITED

Top Countries Importing Fluorouracil from India

130 destination markets · Ranked by import value

All 130 countries →

Top Countries Importing Fluorouracil from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$6.1M	49.4%
2	COLOMBIA	$836.4K	6.8%
3	MOROCCO	$510.0K	4.2%
4	UKRAINE	$453.2K	3.7%
5	THAILAND	$430.8K	3.5%
6	NETHERLANDS	$416.6K	3.4%
7	SPAIN	$334.0K	2.7%
8	FRANCE	$332.2K	2.7%
9	ECUADOR	$223.2K	1.8%
10	CHILE	$217.9K	1.8%

UNITED STATES is India's largest fluorouracil export destination, absorbing 49.4% of total exports worth $6.1M. The top 5 importing countries — UNITED STATES, COLOMBIA, MOROCCO, UKRAINE, THAILAND — together account for 67.5% of India's total fluorouracil export value. The remaining 125 destination countries collectively receive the other 32.5%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Fluorouracil to India?

3 origin countries · Total import value: $10.8K

India imports fluorouracil from 3 countries with a combined import value of $10.8K. The largest supplier is UNITED STATES ($9.3K, 7 shipments), followed by SWITZERLAND and ISRAEL. All values are from Indian Customs (DGFT) import records.

Countries Supplying Fluorouracil to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$9.3K	7	86.2%
2	SWITZERLAND	$983	1	9.1%
3	ISRAEL	$510	1	4.7%

UNITED STATES is the largest supplier of fluorouracil to India, accounting for 86.2% of total import value. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Fluorouracil

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

1FDA & US Market Regulatory Status

Fluorouracil has a longstanding presence in the U.S. pharmaceutical market, with multiple Abbreviated New Drug Applications (ANDAs) approved by the FDA. For instance, Gensia Sicor Pharmaceuticals received approval for ANDA #040333 on February 11, 2000. The FDA's Orange Book lists numerous approved generic versions, reflecting the drug's established therapeutic use and the competitive landscape among manufacturers.

The substantial export volume from India to the U.S., with 49.4% of total exports directed there, underscores the importance of compliance with FDA regulations. Indian exporters must adhere to stringent FDA requirements, including Good Manufacturing Practices (GMP), to ensure product quality and safety. The presence of 231 active Indian exporters highlights the competitive nature of the market, necessitating continuous regulatory vigilance to maintain market access.

2EU & UK Regulatory Framework

In the European Union, fluorouracil is subject to the European Medicines Agency's (EMA) regulatory oversight. The EMA conducts periodic safety update report single assessments (PSUSAs) for fluorouracil, leading to variations in marketing authorizations to enhance safety and efficacy. For example, a PSUSA procedure (PSUSA/00000007/202312) concluded in November 2024 resulted in updates to product information. (ema.europa.eu)

The United Kingdom, through the Medicines and Healthcare products Regulatory Agency (MHRA), aligns with EMA standards, ensuring that fluorouracil products meet rigorous safety and efficacy criteria. Compliance with EU Good Manufacturing Practice (GMP) guidelines is mandatory for manufacturers, emphasizing quality assurance throughout the production process.

3WHO Essential Medicines & Global Standards

Fluorouracil is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its critical role in cancer treatment. The 20th edition of the list, published in March 2017, lists fluorouracil for indications such as early-stage breast cancer, colon cancer, rectal cancer, metastatic colorectal cancer, and nasopharyngeal cancer. (iris.who.int) This inclusion highlights the drug's global therapeutic importance and the necessity for adherence to international pharmacopoeia standards, including those of the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP).

4India Regulatory Classification

In India, fluorouracil is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The Central Drugs Standard Control Organization (CDSCO) oversees its regulation, ensuring compliance with national standards. While fluorouracil is not listed under the Drug Price Control Order (DPCO) by the National Pharmaceutical Pricing Authority (NPPA), manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for export purposes, ensuring adherence to export regulations.

5Patent & Exclusivity Status

Fluorouracil's primary patents have expired, leading to a competitive generic market. The absence of active patents facilitates the production and export of generic versions by multiple manufacturers, contributing to the drug's widespread availability and affordability.

6Recent Industry Developments

In November 2024, the EMA's PSUSA procedure (PSUSA/00000007/202312) for fluorouracil resulted in variations to marketing authorizations, reflecting ongoing efforts to enhance drug safety and efficacy. (ema.europa.eu)

In October 2024, the EMA reported a shortage of fluorouracil injections due to manufacturing capacity issues at a major production site in India. The shortage was anticipated to last until 2025, prompting regulatory bodies to monitor the situation closely and engage with alternative manufacturers to mitigate the impact. (ema.europa.eu)

These developments underscore the dynamic nature of the pharmaceutical industry and the importance of regulatory compliance and proactive supply chain management for Indian exporters of fluorouracil.

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

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Global Price Benchmark — Fluorouracil

Retail & reference prices across 9 markets vs. India FOB export price of $2.69/unit

Global Price Benchmark for Fluorouracil across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$15.00	USD	According to the FDA's Orange Book, Fluorouracil is an approved generic drug, which contributes to its relatively lower cost in the U.S. market.
United Kingdom	$16.00	GBP	The NHS Drug Tariff lists Fluorouracil as a standard chemotherapy agent, with pricing subject to periodic review.
Germany	$15.50	EUR	The Federal Joint Committee (G-BA) includes Fluorouracil in its list of reimbursable medications, with prices negotiated annually.
Australia

Supply Chain Risk Assessment — Fluorouracil

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Fluorouracil, a critical chemotherapeutic 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 significant, as China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a global leader in this sector. Such reliance exposes the supply chain to vulnerabilities stemming from geopolitical tensions, trade disputes, and regulatory changes in China.

Recent disruptions have underscored these risks. In August 2024, the European Medicines Agency (EMA) reported a shortage of fluorouracil injections due to manufacturing capacity issues at a key Indian facility. These issues were partly attributed to delays in receiving essential raw materials from China, highlighting the fragility of the supply chain. (ema.europa.eu) Such incidents emphasize the need for diversified sourcing strategies to mitigate potential supply disruptions.

2Supplier Concentration & Single-Source Risk

The export market for fluorouracil from India is notably concentrated. The top five exporters—INTAS PHARMACEUTICALS LIMITED, ALEMBIC PHARMACEUTICALS LIMITED, NAPROD LIFE SCIENCES PRIVATE LIMITED, GLAND PHARMA LIMITED, and NV REMEDIES PRIVATE LIMITED—collectively account for 78.3% of total exports. INTAS PHARMACEUTICALS LIMITED alone holds a 26.4% share, indicating a significant reliance on a limited number of suppliers. This concentration poses a risk, as any operational or compliance issues within these key companies could lead to substantial supply disruptions.

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Frequently Asked Questions — Fluorouracil Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top fluorouracil exporters from India?

The leading fluorouracil exporters from India are INTAS PHARMACEUTICALS LIMITED, ALEMBIC PHARMACEUTICALS LIMITED, NAPROD LIFE SCIENCES PRIVATE LIMITED, and 12 others. INTAS PHARMACEUTICALS LIMITED leads with 26.4% market share ($3.2M). The top 5 suppliers together control 78.3% of total export value.

What is the total export value of fluorouracil from India?

The total export value of fluorouracil from India is $12.3M, recorded across 2,093 shipments from 231 active exporters to 130 countries. The average shipment value is $5.9K.

Which countries import fluorouracil from India?

India exports fluorouracil to 130 countries. The top importing countries are UNITED STATES (49.4%), COLOMBIA (6.8%), MOROCCO (4.2%), UKRAINE (3.7%), THAILAND (3.5%), which together account for 67.5% of total export value.

What is the HS code for fluorouracil exports from India?

The primary HS code for fluorouracil exports from India is 30049042. 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.

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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.

Fluorouracil

Fluorouracil

Top Fluorouracil Exporters from India

Top Countries Importing Fluorouracil from India

Who Supplies Fluorouracil to India?

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Regulatory Landscape — Fluorouracil

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 — Fluorouracil

Supply Chain Risk Assessment — Fluorouracil

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Fluorouracil Trade Intelligence

Frequently Asked Questions — Fluorouracil Exports from India

Who are the top fluorouracil exporters from India?

What is the total export value of fluorouracil from India?

Which countries import fluorouracil from India?

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

Which ports handle fluorouracil exports from India?

Why is India a leading exporter of fluorouracil?

What certifications do Indian fluorouracil exporters need?

How many buyers import fluorouracil from India?

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

Analysis Methodology