Busulfan Export Market Intelligence: India's 33 Suppliers Shipping to 44 Countries — TransData Nexus 2026

Q: Who are the top busulfan exporters from India?

The top busulfan exporters from India are: 1. INTAS PHARMACEUTICALS LIMITED — $2.0M (40.4% market share); 2. EMCURE PHARMACEUTICALS LIMITED — $1.5M (31.2% market share); 3. FRESENIUS KABI ONCOLOGY LIMITED — $627.6K (12.7% market share); 4. INTAS PHARMACEUTICALS LTD — $324.7K (6.6% market share); 5. SHILPA MEDICARE LIMITED — $150.5K (3.1% market share). Together they account for 94.0% of India's total busulfan export value.

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

The total export value of busulfan from India is $4.9M USD, recorded across 369 shipment transactions from 33 active exporters to 44 destination countries. The average shipment value is $13.4K.

Q: Which countries import busulfan from India?

India exports busulfan to 44 countries worldwide. The top importing countries are: UNITED KINGDOM (25.9% share, $1.3M), PERU (15.4% share, $756.7K), UNITED STATES (11.1% share, $548.0K), GERMANY (9.4% share, $463.2K), MALTA (6.9% share, $341.9K). These five markets account for 68.7% of total export value.

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

The primary HS code for busulfan 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 busulfan exports from India?

The average unit price for busulfan exports from India is $33.77 USD per unit, with prices ranging from $0.01 to $375.74 depending on formulation, packaging, and order volume. The total market is valued at $4.9M across 369 shipments.

Q: Which ports handle busulfan exports from India?

The primary ports for busulfan exports from India are SAHAR AIR CARGO ACC (INBOM4) (20.3% of shipments), SAHAR AIR (16.8% of shipments), DELHI AIR (11.1% of shipments), DELHI AIR CARGO ACC (INDEL4) (8.4% of shipments), AHEMDABAD AIR ACC (INAMD4) (7.0% 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 busulfan?

India is one of the world's leading exporters of busulfan due to its large base of 33 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 busulfan to 44 countries, demonstrating 23% global market coverage.

Q: What certifications do Indian busulfan exporters need?

Indian busulfan 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 busulfan from India?

There are 109 registered buyers importing busulfan from India, spread across 44 countries. The repeat buyer rate is 45.9%, indicating strong long-term trade relationships and consistent product quality.

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

INTAS PHARMACEUTICALS LIMITED is the leading busulfan exporter from India with a market share of 40.4% and total export value of $2.0M across 92 shipments. The top 5 suppliers together control 94.0% of total export value.

Suresh Sormare

Busulfan

India Pharmaceutical Trade Intelligence

$4.9M33 Suppliers44 CountriesHS 30049049

ExportsIndia → UNITED KINGDOM25.9%India → PERU15.4%

ImportsUNITED STATES → India$25.5K BRAZIL → India$3.3K

#1 Supplier: INTAS PHARMACEUTICALS

Busulfan Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Busulfan to the World

Between 2022 and 2026, India exported $4.9M worth of busulfan across 369 verified shipments to 44 countries — covering 23% of world markets in the Advanced Oncology segment. The largest destination is UNITED KINGDOM (25.9%). INTAS PHARMACEUTICALS LIMITED leads with a 40.4% 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·

Busulfan export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Busulfan export data snapshot — $4.9M · 33 exporters · 44 countriesTransData Nexus · Indian Customs Data

Top Busulfan Exporters from India

33 active exporters · Ranked by export value

View all 33 →

Top Busulfan Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	INTAS PHARMACEUTICALS LIMITED	$2.0M	92	15	40.4%
2	EMCURE PHARMACEUTICALS LIMITED

Top Countries Importing Busulfan from India

44 destination markets · Ranked by import value

All 44 countries →

Top Countries Importing Busulfan from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED KINGDOM	$1.3M	25.9%
2	PERU	$756.7K	15.4%
3	UNITED STATES	$548.0K	11.1%
4	GERMANY	$463.2K	9.4%
5	MALTA	$341.9K	6.9%
6	POLAND	$308.9K	6.3%
7	BRAZIL	$168.9K	3.4%
8	COLOMBIA	$158.0K	3.2%
9	SOUTH AFRICA	$133.0K	2.7%
10	ITALY	$111.4K	2.3%

UNITED KINGDOM is India's largest busulfan export destination, absorbing 25.9% of total exports worth $1.3M. The top 5 importing countries — UNITED KINGDOM, PERU, UNITED STATES, GERMANY, MALTA — together account for 68.7% of India's total busulfan export value. The remaining 39 destination countries collectively receive the other 31.3%, indicating a focused distribution strategy targeting key markets.

Who Supplies Busulfan to India?

3 origin countries · Total import value: $30.8K

India imports busulfan from 3 countries with a combined import value of $30.8K. The largest supplier is UNITED STATES ($25.5K, 3 shipments), followed by BRAZIL and CHINA. All values are from Indian Customs (DGFT) import records.

Countries Supplying Busulfan to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$25.5K	3	82.8%
2	BRAZIL	$3.3K	1	10.8%
3	CHINA	$2.0K	1	6.4%

UNITED STATES is the largest supplier of busulfan to India, accounting for 82.8% of total import value. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Busulfan

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

1FDA & US Market Regulatory Status

Busulfan, marketed under the trade name Busulfex, received FDA approval on February 4, 1999, for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for busulfan, indicating the presence of generic versions in the U.S. market. As of March 2026, there are no active FDA import alerts specifically targeting busulfan, suggesting compliance with regulatory standards.

The U.S. market's demand for busulfan is reflected in its position as the third-largest importer of the drug from India, accounting for 11.1% of total exports. This underscores the importance of maintaining stringent quality and regulatory compliance among the 33 active Indian exporters to ensure continued market access.

2EU & UK Regulatory Framework

In the European Union, busulfan has been authorized for use as a conditioning treatment prior to hematopoietic progenitor cell transplantation. Notably, Busilvex, a busulfan product, had its marketing authorization withdrawn in January 2023 at the request of the marketing authorization holder, Pierre Fabre Medicament, due to commercial reasons. (ema.europa.eu) Despite this withdrawal, generic versions of busulfan remain authorized and marketed within the EU.

The United Kingdom, having exited the EU, continues to regulate busulfan through the Medicines and Healthcare products Regulatory Agency (MHRA). Manufacturers exporting busulfan to the UK must adhere to the UK's Good Manufacturing Practice (GMP) standards, which align closely with EU GMP requirements.

3WHO Essential Medicines & Global Standards

Busulfan is included in the World Health Organization's Model List of Essential Medicines, underscoring its critical role in healthcare systems worldwide. The drug is also listed in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality and formulation across different regions.

4India Regulatory Classification

In India, busulfan is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for busulfan, allowing market-driven pricing. Exporters are required to obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for the export of busulfan, ensuring compliance with national regulations.

5Patent & Exclusivity Status

The primary patents for busulfan have expired, leading to the availability of generic versions and increased competition in the market. This competitive landscape is reflected in the presence of 33 active Indian exporters supplying busulfan to 44 destination countries.

6Recent Industry Developments

In April 2025, the European Medicines Agency (EMA) conducted a Periodic Safety Update Report Single Assessment (PSUSA) for busulfan, resulting in variations to the terms of marketing authorizations to enhance safety information. (ema.europa.eu)

In January 2023, the marketing authorization for Busilvex was withdrawn in the EU at the request of the marketing authorization holder, Pierre Fabre Medicament, due to commercial reasons. (ema.europa.eu)

In September 2024, the FDA issued a safety communication regarding the use of busulfan, highlighting the need for monitoring due to potential adverse effects.

In November 2025, the NPPA in India reviewed the pricing of busulfan, resulting in a recommendation to maintain current market-driven pricing without imposing a ceiling price.

In February 2026, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of busulfan as a critical medication for conditioning treatment prior to hematopoietic progenitor cell transplantation.

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

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Global Price Benchmark — Busulfan

Retail & reference prices across 9 markets vs. India FOB export price of $33.77/unit

Global Price Benchmark for Busulfan across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	Data not available	USD	The FDA Orange Book lists approved Busulfan formulations, but specific pricing information is not provided.
United Kingdom	Data not available	GBP	The NHS Drug Tariff includes Busulfan, but specific pricing details are not publicly disclosed.
Germany	Data not available	EUR	The Federal Institute for Drugs and Medical Devices (BfArM) regulates pharmaceuticals, but specific Busulfan pricing is not publicly accessible.
Australia	Data not available

Supply Chain Risk Assessment — Busulfan

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Busulfan, a chemotherapy agent, is primarily manufactured in India, which serves as a significant hub for Active Pharmaceutical Ingredient (API) production. However, the production of Busulfan APIs often relies on Key Starting Materials (KSMs) sourced from China. China controls approximately 70–80% of the global KSM supply, making it a dominant player in this sector. This dependency creates a strategic chokepoint; any disruption in Chinese KSM production can directly impact the synthesis of APIs in India, leading to potential shortages of Busulfan.

Recent geopolitical tensions have exacerbated this vulnerability. In February 2026, the closure of the Strait of Hormuz disrupted the supply of petrochemical feedstocks essential for pharmaceutical manufacturing. This disruption affected the availability of solvents and reagents necessary for API synthesis, including those for Busulfan. Such events underscore the fragility of the supply chain, where reliance on specific regions for critical raw materials can lead to significant production challenges.

2Supplier Concentration & Single-Source Risk

The export market for Busulfan from India is highly concentrated. According to TransData Nexus's proprietary trade data, the top five exporters account for 94.0% of total exports, with INTAS PHARMACEUTICALS LIMITED alone holding a 40.4% share. This high level of supplier concentration poses a significant single-source risk; any operational or regulatory issues affecting these key exporters could disrupt the global supply of Busulfan.

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Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 369 transactions across 44 markets.

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Frequently Asked Questions — Busulfan Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top busulfan exporters from India?

The leading busulfan exporters from India are INTAS PHARMACEUTICALS LIMITED, EMCURE PHARMACEUTICALS LIMITED, FRESENIUS KABI ONCOLOGY LIMITED, and 6 others. INTAS PHARMACEUTICALS LIMITED leads with 40.4% market share ($2.0M). The top 5 suppliers together control 94.0% of total export value.

What is the total export value of busulfan from India?

The total export value of busulfan from India is $4.9M, recorded across 369 shipments from 33 active exporters to 44 countries. The average shipment value is $13.4K.

Which countries import busulfan from India?

India exports busulfan to 44 countries. The top importing countries are UNITED KINGDOM (25.9%), PERU (15.4%), UNITED STATES (11.1%), GERMANY (9.4%), MALTA (6.9%), which together account for 68.7% of total export value.

What is the HS code for busulfan exports from India?

The primary HS code for busulfan 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.

Busulfan

Busulfan

Top Busulfan Exporters from India

Top Countries Importing Busulfan from India

Who Supplies Busulfan to India?

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Regulatory Landscape — Busulfan

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 — Busulfan

Supply Chain Risk Assessment — Busulfan

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Busulfan Trade Intelligence

Frequently Asked Questions — Busulfan Exports from India

Who are the top busulfan exporters from India?

What is the total export value of busulfan from India?

Which countries import busulfan from India?

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

Which ports handle busulfan exports from India?

Why is India a leading exporter of busulfan?

What certifications do Indian busulfan exporters need?

How many buyers import busulfan from India?

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

Analysis Methodology