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.
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
| # | Supplier & Formulations | Value | Ctry. | Share |
|---|---|---|---|---|
| 1 | INTAS PHARMACEUTICALS LIMITED PH.DRU. & MED.: BUFANCORD (BUSULFAN CONCMEDICINES BUSULFAN INJ 60MG/10ML BATBUSULFAN INJ 6MG/ML 10ML 1X8V MYLAN USA | $2.0M | 15 | 40.4% |
| 2 | EMCURE PHARMACEUTICALS LIMITED PH.DRU. & MED.: BUFANCORD (BUSULFAN CONCMEDICINES BUSULFAN INJ 60MG/10ML BATBUSULFAN INJ 6MG/ML 10ML 1X8V MYLAN USA | $1.5M | 9 | 31.2% |
| 3 | FRESENIUS KABI ONCOLOGY LIMITED BUSULFAN FRESENIUS KABI INJECTION 60MG/1BUSULFAN FRESENIUS KABI INJ. 60MG/10MLPHR DRUGS & MEDI ACCORAN BUSULFAN 6MG/ML | $627.6K | 7 | 12.7% |
| 4 | INTAS PHARMACEUTICALS LTD PH.DRU. & MED.: BUFANCORD (BUSULFAN CONCMEDICINES BUSULFAN INJ 60MG/10ML BATBUSULFAN INJ 6MG/ML 10ML 1X8V MYLAN USA | $324.7K | 5 | 6.6% |
| 5 | SHILPA MEDICARE LIMITED BUSULFAN INJECTION 60MG/10MLBUSULFAN INJECTION 60 MGBUSULFAN INJECTION 60MG/ML | $150.5K | 4 | 3.1% |
| 6 | SP ACCURE LABS PRIVATE LIMITED | $52.3K | 2 | 1.1% |
| 7 | BRUCK PHARMA PRIVATE LIMITED BUSULFAN INJECTION 60MG/10MLBUSULFAN INJECTION 60 MGBUSULFAN INJECTION 60MG/ML | $19.1K | 2 | 0.4% |
| 8 | GLS PHARMA LIMITED | $18.4K | 4 | 0.4% |
| 9 | MEDINEX HEALTHCARE | $9.8K | 1 | 0.2% |
Related Analysis
Supplier Certification & Compliance Matrix
FDA, WHO-GMP, and EU GMP status for top Busulfan exporters
| 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
The Mumbai-Thane-Raigad belt serves as a critical export gateway for pharmaceutical products, leveraging its proximity to major ports and international trade routes. This region facilitates the efficient export of Busulfan to key markets, including the United Kingdom (25.9%), Peru (15.4%), the United States (11.1%), Germany (9.4%), and Malta (6.9%). The strategic location and well-established logistics infrastructure make this cluster pivotal in India's pharmaceutical export landscape.
4Baddi-Nalagarh — Tax Incentive Zone
The Baddi-Nalagarh region in Himachal Pradesh has attracted numerous pharmaceutical companies due to favorable tax incentives and supportive government policies. This cluster has become a manufacturing hub for various pharmaceutical products, including oncology drugs like Busulfan. The region's growth is indicative of India's strategic initiatives to bolster pharmaceutical manufacturing through regional incentives.
5Sourcing Recommendations
- Diversify Supplier Base: Given that the top five exporters account for 94.0% of Busulfan exports, it's advisable to explore partnerships with emerging manufacturers to mitigate supply chain risks.
- Assess Regulatory Compliance: Prioritize suppliers with certifications from recognized regulatory bodies such as the USFDA, EMA, and WHO to ensure product quality and compliance.
- Evaluate Manufacturing Capabilities: Consider suppliers with integrated operations, including API production and formulation development, to streamline procurement processes.
- Monitor Export Destinations: Stay informed about the primary export markets for Busulfan to align sourcing strategies with global demand trends.
By leveraging the strengths of India's pharmaceutical clusters and adhering to these recommendations, stakeholders can optimize their Busulfan sourcing strategies effectively.
Recent M&A, Collaborations & Capacity Expansions
Industry developments among top Busulfan exporters from India
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.
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.
Emcure Pharmaceuticals Limited — Emcure Pharmaceuticals' Levocarnitine injection flagged by CDSCO
The CDSCO reported in October 2023 that Levocarnitine injections manufactured by Emcure Pharmaceuticals failed to meet quality standards. IMPACT: This quality compliance issue may impact Emcure Pharmaceuticals' credibility and could influence its Busulfan export activities.
Impact: This quality compliance issue may impact Emcure Pharmaceuticals' credibility and could influence its Busulfan export activities.
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
- CDSCO India
- Pharmexcil
- IBEF — India Pharma Industry
- Ministry of Commerce — Pharma Exports
- India Trade Statistics (DGFT)
Verify manufacturer licensing and export certifications with the official agencies above.
Research Methodology & Data Transparency
Suresh Sormare
Verified AuthorPharmaceutical 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/sureshsormarePrimary 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.
Analysis Methodology
- 1.Supplier Ranking: 33 verified Indian exporters of Busulfan ranked by capped export value from DGFT shipping bill records.
- 2.Export Value Analysis: Total export value aggregated from 369 individual shipping bill records. Values are FOB in USD.
- 3.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation.
- 4.Market Concentration: Supplier market share and geographic reach analyzed across 44 destination countries.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
369 Verified Shipments
33 exporters tracked
Expert-Reviewed
By pharmaceutical trade specialists