Fresenius Kabi Oncology Limited — Irinotecan Exporter Profile
Indian Pharmaceutical Exporter · #2 for Irinotecan · $10.4M export value · DGFT Verified
Fresenius Kabi Oncology Limited is the #2 Indian exporter of Irinotecan with $10.4M in export value and 670 verified shipments. Fresenius Kabi Oncology Limited holds a 25.4% market share in Irinotecan exports across 24 countries. The company exports 16 pharmaceutical products worth $117.2M across 3 therapeutic categories.
Fresenius Kabi Oncology Limited — Irinotecan Export Profile: Buyers & Destinations

Where Does Fresenius Kabi Oncology Limited Export Irinotecan?
| Country | Value | Shipments | Share |
|---|---|---|---|
| GERMANY | $7.3M | 452 | 75.9% |
| THAILAND | $445.1K | 25 | 4.6% |
| CHILE | $323.7K | 7 | 3.4% |
| COLOMBIA | $189.1K | 8 | 2.0% |
| MALAYSIA | $151.5K | 12 | 1.6% |
| VIETNAM | $151.4K | 8 | 1.6% |
| VIETNAM, DEMOCRATIC REP. OF | $146.7K | 14 | 1.5% |
| ECUADOR | $99.4K | 6 | 1.0% |
| UNITED ARAB EMIRATES | $90.3K | 22 | 0.9% |
| MEXICO | $66.5K | 3 | 0.7% |
Fresenius Kabi Oncology Limited exports Irinotecan to 27 countries. The largest destination is GERMANY accounting for 75.9% of Fresenius Kabi Oncology Limited's Irinotecan shipments, followed by THAILAND (4.6%) and CHILE (3.4%). These destinations reflect Fresenius Kabi Oncology Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Irinotecan from Fresenius Kabi Oncology Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| FRESENIUS KABI DEUTSCHLAND GMBH | GERMANY | $7.3M | 452 |
| FRESENIUS KABI COLOMBIA SAS | COLOMBIA | $189.1K | 8 |
| FRESENIUS KABI THAILAND LTD | THAILAND | $169.6K | 7 |
| ZUELLIG PHARMA VIETNAM LTD | VIETNAM, DEMOCRATIC REP. OF | $142.2K | 9 |
| FRESENIUS KABI CHILE LTDA | CHILE | $140.4K | 3 |
| FRESENIUS KABI (THAILAND) LTD | THAILAND | $112.0K | 8 |
| FRESENIUS KABI MALAYSIA SDN BHD | MALAYSIA | $93.9K | 7 |
| FRESENIUS KABI (THAILAND) LTD., | THAILAND | $86.6K | 6 |
| FRESENIUS KABI CHILE LTDA. | CHILE | $86.0K | 2 |
| FRESENIUS KABI MEXICO, S.A. DE C.V. | MEXICO | $66.5K | 3 |
Fresenius Kabi Oncology Limited supplies Irinotecan to 73 buyers globally. The largest buyer is FRESENIUS KABI DEUTSCHLAND GMBH (GERMANY), followed by FRESENIUS KABI COLOMBIA SAS (COLOMBIA) and FRESENIUS KABI THAILAND LTD (THAILAND). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Irinotecan Export Value and How Much Does Fresenius Kabi Oncology Limited Contribute?
India exported $37.5M worth of Irinotecan through 2,905 shipments from 164 suppliers to 111 countries, serving 495 buyers globally. Fresenius Kabi Oncology Limited contributes $10.4M to this total, accounting for 25.4% of India's Irinotecan exports. Fresenius Kabi Oncology Limited ships Irinotecan to 27 countries through 73 buyers.
What Is the Average Shipment Value for Fresenius Kabi Oncology Limited's Irinotecan Exports?
Fresenius Kabi Oncology Limited's average Irinotecan shipment value is $15.6K per consignment, based on 670 shipments totaling $10.4M. The largest destination is GERMANY (75.9% of Fresenius Kabi Oncology Limited's Irinotecan exports).
How Does Fresenius Kabi Oncology Limited Compare to Other Indian Irinotecan Exporters?
Fresenius Kabi Oncology Limited ranks #2 among 164 Indian Irinotecan exporters with a 25.4% market share. The top 3 exporters are INTAS PHARMACEUTICALS LIMITED ($14.7M), FRESENIUS KABI ONCOLOGY LIMITED ($10.4M), EUGIA PHARMA SPECIALITIES LIMITED ($4.4M). Fresenius Kabi Oncology Limited processed 670 shipments to 24 destination countries.
What Irinotecan Formulations Does Fresenius Kabi Oncology Limited Export?
| Product Description / 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 Oncology Limited exports 463 distinct Irinotecan formulations including tablets, capsules, syrups, and combination drugs. The top formulation is IRINOTECAN KABI INJ.500MG/25ML VIAL B.NO with 18 shipments worth $488.4K.
Regulatory Requirements: Exporting Irinotecan to Key Markets
What Fresenius Kabi Oncology Limited must comply with to export Irinotecan to its top destination countries
Germany — BfArM/EMA
Approval Process
Marketing Authorisation via Decentralized or Mutual Recognition Procedure under EU Directive 2001/83/EC. CTD Module 1–5 dossier required.
Timeline: 12–18 months via Decentralized Procedure
GMP & Export Requirements
EU GMP (EudraLex Vol. 4); GMP certificate from EU competent authority; WHO Prequalification accepted as supporting evidence
Certificate of Pharmaceutical Product (CPP) from CDSCO; Written Confirmation for API export per EU requirements; EU FMD serialization mandatory
Note: Indian manufacturers must hold EU GMP certificate. EU Falsified Medicines Directive (FMD) serialization and tamper-evident packaging mandatory.
Regulatory information is provided for general reference based on publicly available guidelines. Requirements vary by formulation, dosage form, and therapeutic classification. Exporters should consult qualified regulatory affairs professionals for case-specific guidance.
How Does Fresenius Kabi Oncology Limited Compare to Nearest Irinotecan Exporters?
Exporters ranked immediately above and below #2 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | INTAS PHARMACEUTICALS LIMITED | $14.7M | 1,099 | 20 | $13.4K |
| 2 | FRESENIUS KABI ONCOLOGY LIMITED ★ | $10.4M | 670 | 24 | $15.6K |
| 3 | EUGIA PHARMA SPECIALITIES LIMITED | $4.4M | 88 | 10 | $50.0K |
| 4 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $3.1M | 92 | 3 | $33.8K |
Fresenius Kabi Oncology Limited ranks #2 among 164 Indian Irinotecan exporters. Average shipment value of $15.6K compared to the market average of $228.7K. The closest competitors by value are INTAS PHARMACEUTICALS LIMITED and EUGIA PHARMA SPECIALITIES LIMITED.
Which Indian Ports Ship Irinotecan Exports?
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 300 | 10.3% |
| SAHAR AIR | 296 | 10.2% |
| AHEMDABAD AIR ACC (INAMD4) | 252 | 8.7% |
| MUNDRA SEA (INMUN1) | 217 | 7.5% |
| SAHAR AIR CARGO ACC (INBOM4) | 207 | 7.1% |
| DELHI AIR | 205 | 7.1% |
| AHEMDABAD AIR | 205 | 7.1% |
| MUNDRA SEA | 152 | 5.2% |
What Other Oncology Products Does Fresenius Kabi Oncology Limited Export?
Fresenius Kabi Oncology Limited also exports these oncology products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Fresenius Kabi Oncology Limited's Irinotecan Exports
The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like FKOL. The Israel-Iran conflict has led to disruptions in Red Sea shipping routes, causing maritime carriers to suspend bookings and reroute vessels around the Cape of Good Hope. These changes have resulted in increased freight charges and extended transit times, posing significant risks to time-sensitive pharmaceutical shipments. The Pharmaceutical Export Promotion Council of India (Pharmexcil) estimates potential losses ranging from ₹2,500 crore to ₹5,000 crore due to these disruptions. (fortuneindia.com)
Conversely, U.S.-China trade tensions have created openings for Indian pharmaceutical companies. The U.S. has imposed tariffs on Chinese goods, including pharmaceuticals, prompting American importers to seek alternative suppliers. This shift has benefited Indian exporters, as evidenced by the U.S. accounting for approximately 34.5% of India's pharma exports, valued at around $10.5 billion. (actizaindustry.com) However, the U.S. administration's fluctuating tariff policies, including threats of increased tariffs on pharmaceutical imports, necessitate vigilance and adaptability from exporters like FKOL. (lemonde.fr)
In the European Union, regulatory changes such as the Falsified Medicines Directive (FMD) impose stringent requirements on pharmaceutical imports. Compliance with these regulations demands significant investment in serialization and traceability systems. For FKOL, ensuring adherence to such standards is crucial to maintaining access to the lucrative EU market and upholding its reputation for quality and reliability.
Fresenius Kabi Oncology Limited — Regulatory Compliance & Quality Standards
The global pharmaceutical industry is witnessing heightened regulatory scrutiny, with agencies like the FDA and WHO emphasizing Good Manufacturing Practices (GMP) compliance. Indian exporters, including FKOL, must navigate this evolving landscape to sustain their market positions. Notably, the FDA has increased inspections of Indian manufacturing facilities, with over 200 inspections conducted in 2023 and plans to escalate this number in 2024. (fact.net.in)
FKOL's commitment to quality is evident in its state-of-the-art Research & Development center in Gurgaon, India. The facility focuses on developing next-generation cytotoxic and cytostatic therapies, ensuring that products meet the highest quality standards irrespective of the target market. (fresenius-kabi-oncology.com) This proactive approach to quality assurance positions FKOL favorably in a competitive and regulated global market.
About Fresenius Kabi Oncology Limited
Fresenius Kabi Oncology Limited exports 16 products worth $117.2M. Beyond Irinotecan, top products include Carboplatin, Paclitaxel, Oxaliplatin, Pemetrexed, Docetaxel. View the complete Fresenius Kabi Oncology Limited 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
- 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.Product Matching: Irinotecan shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Fresenius Kabi Oncology Limited matched across shipments using name normalization, 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 company rankings.
- 4.Verified Records: This page is backed by 681 individual customs records matching Fresenius Kabi Oncology Limited exporting Irinotecan, covering 463 formulations to 27 countries via 73 buyers.
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 Export Data from Fresenius Kabi Oncology Limited
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Fresenius Kabi Oncology Limited
Full Company Profile →
16 products · $117.2M total trade · 3 categories
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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 shipment-level data, contact TransData Nexus.