FRESENIUS KABI DEUTSCHLAND GMBH — Busulfan Importer Profile
Pharmaceutical Importer · #3 buyer for Busulfan · $463.2K import value · 67 shipments · GERMANY · DGFT Verified
FRESENIUS KABI DEUTSCHLAND GMBH is the #3 importer of Busulfan from India with $463.2K in import value and 67 verified shipments. FRESENIUS KABI DEUTSCHLAND GMBH holds a 8.7% market share in Busulfan imports based in GERMANY. The company sources from 1 verified supplier across 35 formulations shipped to 1 country. Overall, FRESENIUS KABI DEUTSCHLAND GMBH imports 10 pharmaceutical products worth $65.5M across 2 therapeutic categories.
FRESENIUS KABI DEUTSCHLAND GMBH — Busulfan Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Busulfan to FRESENIUS KABI DEUTSCHLAND GMBH?
Verified from 67 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| FRESENIUS KABI ONCOLOGY LIMITED | $463.2K | 67 | 100.0% |
FRESENIUS KABI DEUTSCHLAND GMBH sources Busulfan from 1 verified Indian supplier based on 67 customs records. The primary supplier is FRESENIUS KABI ONCOLOGY LIMITED accounting for 100.0% of imports.
How Does FRESENIUS KABI DEUTSCHLAND GMBH Compare to Nearest Busulfan Importers?
Buyers ranked immediately above and below #3 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | TILLOMED LABORATORIES LTD | UNITED KINGDOM | $619.7K | 25 | $24.8K |
| 3 | FRESENIUS KABI DEUTSCHLAND GMBH ★ | GERMANY | $426.4K | 60 | $7.1K |
| 4 | TILLOMED LABORATORIES LIMITED | UNITED KINGDOM | $404.7K | 22 | $18.4K |
| 6 | TILLOMED MALTA LTD | MALTA | $235.8K | 16 | $14.7K |
FRESENIUS KABI DEUTSCHLAND GMBH ranks #3 among 109 Busulfan importers from India. Average shipment value of $7.1K compared to the market average of $24.7K. The closest competitors by value are TILLOMED LABORATORIES LTD and TILLOMED LABORATORIES LIMITED.
Where Does FRESENIUS KABI DEUTSCHLAND GMBH Import Busulfan To?
Destination countries from 67 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| GERMANY | $463.2K | 67 | 100.0% |
FRESENIUS KABI DEUTSCHLAND GMBH imports Busulfan to 1 country. The primary destination is GERMANY receiving 100.0% of shipments worth $463.2K.
What Busulfan Formulations Does FRESENIUS KABI DEUTSCHLAND GMBH Import?
| Formulation | Value | Shipments |
|---|---|---|
| BUSULFAN FRESENIUS KABI INJECTION 60MG/1 | $144.9K | 25 |
| BUSULFAN FRESENIUS KABI INJ. 60MG/10ML B | $46.6K | 8 |
| BUSULFAN FRESENIUS KABI INJ. 60MG/10ML (BATCH NO. 87250104AA MFG. DT. 03/2025 EXP. DT. 02/2027) | $19.5K | 1 |
| BUSULFAN FRESENIUS KABI INJ. 60MG/10ML BATCH NO 87230391AA, MANUFACTURING . DT. 08/2023, EXP. DT. 07/2025 | $19.3K | 1 |
| BUSULFAN FRESENIUS KABI INJ. 60MG/10ML (BATCH NO. 87250105AA MFG. DT. 03/2025 EXP. DT. 02/2027) | $16.8K | 1 |
| BUSULFAN FRESENIUS KABI INJ. 60MG/10ML (BATCH NO. 87250105AD MFG. DT. 03/2025 EXP. DT. 02/2027) | $14.8K | 1 |
| BUSULFAN FRESENIUS KABI INJ. 60MG/10ML (BATCH NO. 87250104AB MFG. DT. 03/2025 EXP. DT. 02/2027) | $14.7K | 1 |
| BUSULFAN FRESENIUS KABI INJ. 60MG/10ML BATCH NO. 87230476AA, MFG. DT. 11/2023,EXP. DT. 10/2025 | $14.1K | 1 |
| BUSULFAN FRESENIUS KABI INJ. 60MG/10ML BATCH NO. 87240030AA MFG. DT. 01/2024 EXP. DT. 12/2025 | $13.9K | 1 |
| BUSULFAN FRESENIUS KABI INJ. 60MG/10M BATCH NO. 87230391AB, MANUFACTURING . DT. 08/2023, EXP. DT. 07/2025 | $13.7K | 1 |
FRESENIUS KABI DEUTSCHLAND GMBH imports 35 distinct Busulfan formulations from India. The top formulation is BUSULFAN FRESENIUS KABI INJECTION 60MG/1 with 25 shipments worth $144.9K.
Regulatory Requirements: Importing Busulfan into Germany
What FRESENIUS KABI DEUTSCHLAND GMBH and other importers must comply with to import Busulfan from India
Regulatory Authority
Federal Institute for Drugs and Medical Devices (BfArM) / European Medicines Agency (EMA) (BfArM/EMA)
Approval Process for Generic Busulfan
Marketing Authorisation Application (MAA) under EU Directive 2001/83/EC. Decentralized or Mutual Recognition Procedure for generics. Requires CTD Module 1–5 dossier.
Typical timeline: 12–18 months via Decentralized Procedure
GMP Requirements
EU GMP (EudraLex Vol. 4) compliance; GMP certificate issued by competent authority; WHO Prequalification accepted as supporting evidence
Import Licence & Documentation
Wholesale Distribution Authorisation (WDA) and Manufacturing/Import Authorisation (MIA) required for importer. Qualified Person (QP) must certify each batch.
Labeling & Packaging
EU labeling per Directive 2001/83/EC; German language patient leaflet (PIL) mandatory; serialization under EU Falsified Medicines Directive (FMD)
Note: EU FMD serialization and tamper-evident packaging mandatory since February 2019. Indian API/FDF manufacturers must hold EU GMP certificate.
Regulatory information is provided for general reference based on publicly available BfArM/EMA guidelines for pharmaceutical imports. Requirements may vary by specific drug formulation, dosage form, and therapeutic classification. Importers should consult directly with BfArM/EMA or qualified regulatory affairs professionals for case-specific guidance.
Who Are the Top Buyers of Busulfan from India and How Much Does FRESENIUS KABI DEUTSCHLAND GMBH Import?
India exported $2.7M worth of Busulfan through 369 shipments from 33 suppliers to 44 countries, serving 109 buyers globally. FRESENIUS KABI DEUTSCHLAND GMBH imports $463.2K of this total, accounting for 8.7% of India's Busulfan exports with 67 shipments from GERMANY. This is verified from 67 customs shipment records covering 35 distinct formulations.
What Is the Average Order Value for FRESENIUS KABI DEUTSCHLAND GMBH's Busulfan Imports?
FRESENIUS KABI DEUTSCHLAND GMBH's average Busulfan order value is $6.9K per consignment, based on 67 shipments totaling $463.2K. FRESENIUS KABI DEUTSCHLAND GMBH is based in GERMANY and ranks #3 among all Busulfan importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Busulfan to FRESENIUS KABI DEUTSCHLAND GMBH?
FRESENIUS KABI DEUTSCHLAND GMBH sources Busulfan from 1 verified Indian supplier: FRESENIUS KABI ONCOLOGY LIMITED ($463.2K, 100.0%). This is based on 67 customs records.
How Does FRESENIUS KABI DEUTSCHLAND GMBH Compare to Other Busulfan Importers?
FRESENIUS KABI DEUTSCHLAND GMBH ranks #3 among 109 Busulfan importers from India with a 8.7% market share. The top 3 importers are TILLOMED LABORATORIES LTD ($619.7K), FRESENIUS KABI DEUTSCHLAND GMBH ($426.4K), TILLOMED LABORATORIES LIMITED ($404.7K). FRESENIUS KABI DEUTSCHLAND GMBH processed 67 shipments from GERMANY.
What Other Advanced Oncology Products Does FRESENIUS KABI DEUTSCHLAND GMBH Import?
FRESENIUS KABI DEUTSCHLAND GMBH also imports these advanced oncology products. Each links to the detailed product page.
About FRESENIUS KABI DEUTSCHLAND GMBH
FRESENIUS KABI DEUTSCHLAND GMBH imports 10 products worth $65.5M. Beyond Busulfan, top products include Paclitaxel, Carboplatin, Oxaliplatin, Pemetrexed, Irinotecan. View the complete FRESENIUS KABI DEUTSCHLAND GMBH profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Busulfan — including regulatory updates, trade policy changes, and competitive landscape analysis — will be available in an upcoming update. This section will feature AI-researched insights from verified industry sources, government notifications, and market reports.
Official References & Regulatory Resources
- European Medicines Agency
- WHO Essential Medicines
- Invest India — Pharma Sector
- India Trade Statistics (DGFT)
Verify import regulations and drug registration requirements with the 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.Product Matching: Busulfan shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: FRESENIUS KABI DEUTSCHLAND GMBH matched across shipments using first-3-word normalization of the consignee field, accounting for company name formatting variations.
- 3.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation. This removes the impact of unusually large one-off transactions that could distort buyer rankings.
- 4.Market Share: Calculated as FRESENIUS KABI DEUTSCHLAND GMBH's capped import value divided by total capped export value for Busulfan across all Indian exporters.
- 5.Verified Records: This page is backed by 67 individual customs records matching FRESENIUS KABI DEUTSCHLAND GMBH importing Busulfan, covering 35 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 44+ countries, 109+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Busulfan Import Data for FRESENIUS KABI DEUTSCHLAND GMBH
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FRESENIUS KABI DEUTSCHLAND GMBH
Full Company Profile →
10 products · $65.5M total trade · 2 categories
FRESENIUS KABI DEUTSCHLAND GMBH × Busulfan
Verified from customs records
Company Overview
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Trade data sourced from Indian Customs (DGFT) export shipment records. Values represent FOB export value in USD. Market share calculated relative to total Indian pharmaceutical exports for Busulfan. For current order-level data, contact TransData Nexus.