FRESENIUS KABI DEUTSCHLAND GMBH — Irinotecan Importer Profile
Pharmaceutical Importer · #1 buyer for Irinotecan · $7.3M import value · 452 shipments · GERMANY · DGFT Verified
FRESENIUS KABI DEUTSCHLAND GMBH is the #1 importer of Irinotecan from India with $7.3M in import value and 452 verified shipments. FRESENIUS KABI DEUTSCHLAND GMBH holds a 19.6% market share in Irinotecan imports based in GERMANY. The company sources from 1 verified supplier across 290 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 — Irinotecan Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Irinotecan to FRESENIUS KABI DEUTSCHLAND GMBH?
Verified from 452 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| FRESENIUS KABI ONCOLOGY LIMITED | $7.3M | 452 | 100.0% |
FRESENIUS KABI DEUTSCHLAND GMBH sources Irinotecan from 1 verified Indian supplier based on 452 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 Irinotecan Importers?
Buyers ranked immediately above and below #1 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | FRESENIUS KABI DEUTSCHLAND GMBH ★ | GERMANY | $8.1M | 452 | $17.9K |
| 2 | YUSEN LOGISTICS BENELUX BELGIUM | BELGIUM | $2.8M | 78 | $35.4K |
| 3 | ALLOGA FRANCE | NETHERLANDS | $2.4M | 50 | $48.8K |
FRESENIUS KABI DEUTSCHLAND GMBH ranks #1 among 495 Irinotecan importers from India. Average shipment value of $17.9K compared to the market average of $45.7K. The closest competitors by value are YUSEN LOGISTICS BENELUX BELGIUM and ALLOGA FRANCE.
Where Does FRESENIUS KABI DEUTSCHLAND GMBH Import Irinotecan To?
Destination countries from 452 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| GERMANY | $7.3M | 452 | 100.0% |
FRESENIUS KABI DEUTSCHLAND GMBH imports Irinotecan to 1 country. The primary destination is GERMANY receiving 100.0% of shipments worth $7.3M.
What Irinotecan Formulations Does FRESENIUS KABI DEUTSCHLAND GMBH Import?
| Formulation | Value | Shipments |
|---|---|---|
| IRINOTECAN KABI INJ.500MG/25ML VIAL B.NO | $488.4K | 18 |
| IRINOTECAN KABI INJ.300MG/15ML VIAL B.NO | $270.1K | 11 |
| IRINOTECAN KABI INJ. 500MG/25ML VIAL(Ite | $266.6K | 10 |
| IRINOTECAN KABI INJ.100MG/5ML VIAL B.NO. | $254.8K | 22 |
| IRINOTECAN KABI INJ. 500MG/25ML VIAL B/N | $177.6K | 9 |
| IRINOTECAN KABI INJ. 300MG/15ML VIAL BAT | $152.2K | 6 |
| IRINOTECAN FRESENIUS KABI INJ.500MG/25ML | $151.6K | 9 |
| IRINOTECAN FRESENIUS KABI INJ. 300MG/15M | $131.1K | 9 |
| IRINOTECAN FRESENIUS KABI INJ.300MG/15ML | $129.0K | 6 |
| IRINOTECAN KABI INJ. 500MG/25ML VIAL, BA | $115.5K | 4 |
FRESENIUS KABI DEUTSCHLAND GMBH imports 290 distinct Irinotecan formulations from India. The top formulation is IRINOTECAN KABI INJ.500MG/25ML VIAL B.NO with 18 shipments worth $488.4K.
Regulatory Requirements: Importing Irinotecan into Germany
What FRESENIUS KABI DEUTSCHLAND GMBH and other importers must comply with to import Irinotecan from India
Regulatory Authority
Federal Institute for Drugs and Medical Devices (BfArM) / European Medicines Agency (EMA) (BfArM/EMA)
Approval Process for Generic Irinotecan
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 Irinotecan from India and How Much Does FRESENIUS KABI DEUTSCHLAND GMBH Import?
India exported $22.6M worth of Irinotecan through 2,905 shipments from 164 suppliers to 111 countries, serving 495 buyers globally. FRESENIUS KABI DEUTSCHLAND GMBH imports $7.3M of this total, accounting for 19.6% of India's Irinotecan exports with 452 shipments from GERMANY. This is verified from 452 customs shipment records covering 290 distinct formulations.
What Is the Average Order Value for FRESENIUS KABI DEUTSCHLAND GMBH's Irinotecan Imports?
FRESENIUS KABI DEUTSCHLAND GMBH's average Irinotecan order value is $16.1K per consignment, based on 452 shipments totaling $7.3M. FRESENIUS KABI DEUTSCHLAND GMBH is based in GERMANY and ranks #1 among all Irinotecan importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Irinotecan to FRESENIUS KABI DEUTSCHLAND GMBH?
FRESENIUS KABI DEUTSCHLAND GMBH sources Irinotecan from 1 verified Indian supplier: FRESENIUS KABI ONCOLOGY LIMITED ($7.3M, 100.0%). This is based on 452 customs records.
How Does FRESENIUS KABI DEUTSCHLAND GMBH Compare to Other Irinotecan Importers?
FRESENIUS KABI DEUTSCHLAND GMBH ranks #1 among 495 Irinotecan importers from India with a 19.6% market share. The top 3 importers are FRESENIUS KABI DEUTSCHLAND GMBH ($8.1M), YUSEN LOGISTICS BENELUX BELGIUM ($2.8M), ALLOGA FRANCE ($2.4M). FRESENIUS KABI DEUTSCHLAND GMBH processed 452 shipments from GERMANY.
What Other Oncology Products Does FRESENIUS KABI DEUTSCHLAND GMBH Import?
FRESENIUS KABI DEUTSCHLAND GMBH also imports these 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 Irinotecan, top products include Paclitaxel, Carboplatin, Oxaliplatin, Pemetrexed, Docetaxel. View the complete FRESENIUS KABI DEUTSCHLAND GMBH profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Irinotecan — 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: Irinotecan 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 Irinotecan across all Indian exporters.
- 5.Verified Records: This page is backed by 452 individual customs records matching FRESENIUS KABI DEUTSCHLAND GMBH importing Irinotecan, covering 290 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 111+ countries, 495+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Irinotecan 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 × Irinotecan
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 Irinotecan. For current order-level data, contact TransData Nexus.