Indian Busulfan Exporters: Complete Supplier Ranking with Market Share — 33 Manufacturers (2026) — TransData Nexus

Q: Who is the largest busulfan supplier from India?

INTAS PHARMACEUTICALS LIMITED is the largest busulfan exporter from India with a 40.4% market share and export value of $2.0M.

Q: How many busulfan suppliers are there in India?

There are 33 active busulfan exporters in India, collectively shipping $4.9M worth of busulfan across 369 shipments according to Indian Customs (DGFT) records.

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

The top 5 busulfan suppliers from India — INTAS PHARMACEUTICALS LIMITED, EMCURE PHARMACEUTICALS LIMITED, FRESENIUS KABI ONCOLOGY LIMITED, INTAS PHARMACEUTICALS LTD, SHILPA MEDICARE LIMITED — together control 94.0% of total busulfan export value from India.

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 Suppliers from India (2026) — 33 Exporters, $4.9M Market | TransData Nexus | TransData Nexus

Who Exports Busulfan from India — 33 Suppliers Behind a $4.9M Market

India's busulfan export market is supplied by 33 active exporters who collectively shipped $4.9M across 369 shipments. INTAS PHARMACEUTICALS LIMITED leads with a 40.4% market share, followed by EMCURE PHARMACEUTICALS LIMITED and FRESENIUS KABI ONCOLOGY LIMITED. The top 5 suppliers together control 94.0% of total export value, reflecting a concentrated market structure.

Source: Indian Customs (DGFT)·Published March 2026

India's Top Busulfan Suppliers & Exporters — 33 manufacturers, $4.9M export market, top destinations and formulations — Busulfan supplier data — 33 exporters · $4.9M market · 369 shipmentsTransData Nexus · Indian Customs Data

Top Busulfan Exporters from India — Ranked by Export Value

INTAS PHARMACEUTICALS LIMITED is the leading busulfan exporter from India, holding a 40.4% share of the $4.9M market across 369 shipments from 33 exporters. The top 5 suppliers — INTAS PHARMACEUTICALS LIMITED, EMCURE PHARMACEUTICALS LIMITED, FRESENIUS KABI ONCOLOGY LIMITED, INTAS PHARMACEUTICALS LTD, SHILPA MEDICARE LIMITED — collectively control 94.0% of total export value, indicating a highly concentrated market. Individual shares are: INTAS PHARMACEUTICALS LIMITED (40.4%), EMCURE PHARMACEUTICALS LIMITED (31.2%), FRESENIUS KABI ONCOLOGY LIMITED (12.7%), INTAS PHARMACEUTICALS LTD (6.6%), SHILPA MEDICARE LIMITED (3.1%).

Top Busulfan Exporters from India

Ranked by export value · 33 active suppliers · Indian Customs (DGFT) data

Mar 2026

Top Busulfan Exporters from India — Ranked by Export Value. 33 active suppliers with export value, shipments, countries and formulations data compiled from Indian Customs records by TransData Nexus.
#	Supplier & Formulations	Value	Ships.	Ctry.	Share
1

Supplier Certification & Compliance Matrix

FDA, WHO-GMP, and EU GMP status for top Busulfan exporters

Certification and compliance status for top Busulfan suppliers from India
Supplier	US FDA	WHO-GMP	EU GMP	ANDAs	Notes
Intas Pharmaceuticals Limited	Warning Letter, July 2023	Unknown	Unknown	Not verified	FDA issued a warning letter citing CGMP violations at the Sanand facility.
Emcure Pharmaceuticals Limited	Warning Letter, August 20	Unknown	Unknown	Not verified	FDA issued a warning letter for CGMP violations at the Pune facility.
Fresenius Kabi Oncology Limited	Unknown	Unknown	Unknown	Not verified	No specific FDA, WHO-GMP, or EU GMP data found.
Shilpa Medicare Limited	Unknown	Unknown	Unknown	Not verified	No specific FDA, WHO-GMP, or EU GMP data found.
SP Accure Labs Private Limited	Unknown	Unknown	Unknown	Not verified	No specific FDA, WHO-GMP, or EU GMP data found.
Bruck Pharma Private Limited	Unknown	Unknown	Unknown	Not verified	No specific FDA, WHO-GMP, or EU GMP data found.
GLS Pharma Limited	Unknown	Unknown	Unknown	Not verified	No specific FDA, WHO-GMP, or EU GMP data found.
Medinex Healthcare	Unknown	Unknown	Unknown	Not verified	No specific FDA, WHO-GMP, or EU GMP data found.

TransData Nexus reviewed the regulatory standing of 8 leading Busulfan exporters from India. 0 hold US FDA facility approvals, 0 maintain WHO-GMP certification, and 0 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 Busulfan sourcing

1Hyderabad — Bulk Drug Capital

Hyderabad, often referred to as the "Bulk Drug Capital of India," is renowned for its extensive production of Active Pharmaceutical Ingredients (APIs). The city's pharmaceutical ecosystem is supported by state-of-the-art manufacturing facilities and a robust infrastructure conducive to large-scale API production. Companies like Shilpa Medicare Limited, headquartered in Raichur, Karnataka, have operations in this region and are known for producing Busulfan API. Shilpa Medicare's facilities are approved by regulatory bodies such as the USFDA, AGES-Austria, PMDA, and WHO, underscoring the high standards maintained in this cluster.

2Ahmedabad-Vadodara — Formulations Hub

The Ahmedabad-Vadodara corridor in Gujarat has emerged as a significant hub for pharmaceutical formulations. This region is home to leading companies like Intas Pharmaceuticals Limited and Emcure Pharmaceuticals Limited, which are major contributors to Busulfan exports. Intas Pharmaceuticals Limited accounted for $2.0 million (40.4%) of the total Busulfan exports, while Emcure Pharmaceuticals Limited contributed $1.5 million (31.2%). The presence of these companies highlights the region's capacity for high-quality formulation development and manufacturing.

3Mumbai-Thane-Raigad — Export Gateway

Recent M&A, Collaborations & Capacity Expansions

Industry developments among top Busulfan exporters from India

June 2023

Regulatory

Shilpa Medicare Limited — Shilpa Medicare gains CDSCO approval for Lenvatinib Capsules

Shilpa Medicare Limited received approval from the Central Drugs Standard Control Organisation (CDSCO) in June 2023 to manufacture and sell Lenvatinib Capsules (12 mg, 18 mg, and 24 mg) in India. IMPACT: This approval may enhance Shilpa Medicare's oncology portfolio, potentially influencing its Busulfan export capabilities.

Impact: This approval may enhance Shilpa Medicare's oncology portfolio, potentially influencing its Busulfan export capabilities.

October 2023

Regulatory

Intas Pharmaceuticals Limited — Intas Pharmaceuticals' bisoprolol fumarate tablets fail CDSCO quality tests

In October 2023, the CDSCO identified that bisoprolol fumarate tablets produced by Intas Pharmaceuticals did not meet quality standards. IMPACT: Such compliance issues could affect Intas Pharmaceuticals' reputation and may have implications for its Busulfan export operations.

Impact: Such compliance issues could affect Intas Pharmaceuticals' reputation and may have implications for its Busulfan export operations.

Common Questions — Busulfan Suppliers from India

Answers based on Indian Customs (DGFT) shipment records compiled by TransData Nexus

Q Which busulfan supplier from India is the most reliable for bulk orders?

Based on shipment frequency and export consistency, INTAS PHARMACEUTICALS LIMITED leads with 92 recorded shipments worth $2.0M. EMCURE PHARMACEUTICALS LIMITED (109 shipments) and FRESENIUS KABI ONCOLOGY LIMITED (77 shipments) are also established high-volume exporters.

Q How many busulfan manufacturers are there in India?

India has 33 active busulfan exporters with a combined export market of $4.9M across 369 shipments to 44 countries. The top 5 suppliers hold 94.0% 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 busulfan from India?

Average FOB unit price: $33.77 per unit, ranging from $0.01 to $375.74. Average shipment value: $13.4K.

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

Who Exports Busulfan from India — 33 Suppliers Behind a $4.9M Market

Top Busulfan Exporters from India — Ranked by Export Value

Top Busulfan Exporters from India

Related Analysis

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Supplier Certification & Compliance Matrix

Manufacturing Hub Analysis — Vendor Proximity

1Hyderabad — Bulk Drug Capital

2Ahmedabad-Vadodara — Formulations Hub

3Mumbai-Thane-Raigad — Export Gateway

Recent M&A, Collaborations & Capacity Expansions

Shilpa Medicare Limited — Shilpa Medicare gains CDSCO approval for Lenvatinib Capsules

Intas Pharmaceuticals Limited — Intas Pharmaceuticals' bisoprolol fumarate tablets fail CDSCO quality tests

Common Questions — Busulfan Suppliers from India

Q Which busulfan supplier from India is the most reliable for bulk orders?

Q How many busulfan manufacturers are there in India?

Q What certifications should I verify?

Q What is the typical price range for busulfan from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

4Baddi-Nalagarh — Tax Incentive Zone

5Sourcing Recommendations

Emcure Pharmaceuticals Limited — Emcure Pharmaceuticals' Levocarnitine injection flagged by CDSCO

Analysis Methodology