Suppliers and packagers for eloxatin

eloxatin

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1731-10	1 VIAL, GLASS in 1 CARTON (0955-1731-10) / 10 mL in 1 VIAL, GLASS	2015-09-01
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1733-20	1 VIAL, GLASS in 1 CARTON (0955-1733-20) / 20 mL in 1 VIAL, GLASS	2015-09-01

Eloxatin (Oxaliplatin) Supplier Landscape

Last updated: February 19, 2026

This analysis examines the supply chain for Eloxatin (oxaliplatin), a platinum-based chemotherapy agent. Key suppliers, manufacturing capabilities, and regulatory considerations are detailed to inform strategic sourcing and investment decisions.

Who are the primary manufacturers of oxaliplatin active pharmaceutical ingredient (API)?

The global market for oxaliplatin API is served by a limited number of established manufacturers. These suppliers possess specialized expertise in complex inorganic synthesis and adhere to stringent pharmaceutical quality standards.

• Key API Manufacturers:
  • Hengrui Medicine Co., Ltd. (China): A leading Chinese pharmaceutical company with significant API manufacturing capacity. Hengrui has a substantial portfolio of oncology products and associated APIs.
  • Beacon Pharmaceuticals Ltd. (Bangladesh): A vertically integrated pharmaceutical company that produces both finished dosage forms and APIs, including oxaliplatin.
  • Nanjing Sanhome Pharmaceutical Co., Ltd. (China): Specializes in the research, development, and production of APIs, with a focus on oncology and cardiovascular therapeutic areas.
  • Teva Pharmaceutical Industries Ltd. (Israel): A major global generic drug manufacturer with a broad API production network. Teva is known for its extensive portfolio and established supply chain management.
  • Cipla Limited (India): A multinational pharmaceutical company with a strong presence in generic drug manufacturing and API production. Cipla has diversified its offerings across various therapeutic segments.

These manufacturers operate under Good Manufacturing Practices (GMP) and are subject to audits by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

What are the manufacturing challenges and quality control requirements for oxaliplatin?

Oxaliplatin synthesis presents significant manufacturing complexities due to its platinum-based structure and the need for high purity.

• Synthesis Complexity: The multi-step synthesis involves sensitive reagents and precise control of reaction conditions to ensure stereochemical purity and minimize impurities. Platinum handling requires specialized facilities and safety protocols.
• Impurity Profiling: Strict limits are placed on residual solvents, heavy metals (beyond platinum), and related substances. Impurities can arise from starting materials, intermediates, or degradation products. Analytical methods for detection and quantification must be highly sensitive and validated.
• Sterility and Pyrogenicity: As an injectable drug, oxaliplatin API must meet stringent requirements for sterility and be free from pyrogenic substances. This necessitates aseptic processing and terminal sterilization validation.
• Regulatory Compliance: API manufacturers must maintain comprehensive documentation, including Drug Master Files (DMFs) or Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs), detailing manufacturing processes, quality controls, and stability data. These are reviewed by regulatory bodies during the drug approval process for finished drug products.
• Batch-to-Batch Consistency: Ensuring consistent API quality across different manufacturing batches is critical for predictable drug product performance and patient safety. This involves robust process validation and in-process controls.

Which countries are dominant in oxaliplatin API production?

China and India are the leading countries in the global production of oxaliplatin API, driven by cost efficiencies and a well-established chemical synthesis industry.

• Dominant Production Regions:
  • China: Holds a significant share of the global oxaliplatin API market. Numerous Chinese chemical and pharmaceutical companies are involved in its production.
  • India: Another major hub for API manufacturing, with several Indian pharmaceutical companies producing oxaliplatin.
  • Bangladesh: Emerging as a supplier, with companies like Beacon Pharmaceuticals actively participating in the market.
  • Israel: Companies like Teva leverage their global manufacturing footprint to supply oxaliplatin API.

The concentration of manufacturing in these regions highlights their established infrastructure and expertise in complex API synthesis.

What are the primary finished dosage form manufacturers of oxaliplatin?

The finished dosage form market for oxaliplatin is comprised of both originator and generic manufacturers. The availability of oxaliplatin generics has significantly expanded market access.

• Key Finished Dosage Form Manufacturers (Examples):
  • Sanofi S.A. (France): The originator of Eloxatin. Sanofi continues to market the brand-name product globally.
  • Teva Pharmaceutical Industries Ltd. (Israel): A major generic manufacturer with oxaliplatin injections available in numerous markets.
  • Accord Healthcare Ltd. (UK): A significant player in the European generics market, offering oxaliplatin.
  • Fresenius Kabi AG (Germany): Known for its parenteral nutrition and injectable drugs, Fresenius Kabi manufactures oxaliplatin infusions.
  • Mylan N.V. (Netherlands, now part of Viatris): A global generic and specialty pharmaceutical company that has offered oxaliplatin products.
  • Dr. Reddy's Laboratories (India): A major global pharmaceutical company with a strong generics portfolio, including oxaliplatin.

These companies source API from primary manufacturers and formulate it into injectable solutions. They are responsible for the final product's quality, packaging, and distribution, and must comply with the regulatory requirements of the target markets.

What is the regulatory pathway for oxaliplatin products and their suppliers?

The regulatory pathway for oxaliplatin products involves multiple stages, with stringent requirements for both API manufacturers and finished drug product producers.

• API Supplier Registration:
  • Drug Master Files (DMFs) / Certificates of Suitability (CEPs): API manufacturers must submit detailed information about their manufacturing process, quality control, and stability data to regulatory agencies. In the U.S., this is typically a DMF. In Europe, a CEP issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) is common. These documents are referenced by finished drug product applicants.
  • Regulatory Inspections: API manufacturing sites are subject to inspection by agencies like the FDA and EMA to ensure compliance with GMP.
• Finished Drug Product Approval:
  • Abbreviated New Drug Application (ANDA) / Marketing Authorisation Application (MAA): Generic drug manufacturers submit applications demonstrating bioequivalence to the reference listed drug (RLD), along with detailed chemistry, manufacturing, and controls (CMC) information. This includes the quality of the sourced API.
  • Quality Agreements: Finished drug product manufacturers establish quality agreements with their API suppliers. These agreements define the responsibilities for quality control, change management, and issue resolution.
• Post-Market Surveillance:
  • Pharmacovigilance: Ongoing monitoring for adverse events is required for both API and finished drug products.
  • Annual Reports: Manufacturers typically submit annual reports to regulatory agencies summarizing manufacturing changes, quality data, and adverse event information.

The regulatory oversight ensures the safety, efficacy, and quality of oxaliplatin products from API synthesis through to patient administration.

What are the typical supply chain risks for oxaliplatin?

The supply chain for oxaliplatin is susceptible to various risks that can impact availability and cost.

• Geopolitical Instability: Concentration of API manufacturing in specific regions can create vulnerabilities to trade disruptions, political unrest, or natural disasters in those areas.
• Raw Material Sourcing: The synthesis of oxaliplatin relies on specific precursor chemicals and platinum salts. Disruptions in the supply of these raw materials, or significant price fluctuations, can affect API production.
• Regulatory Changes: Evolving regulatory requirements, particularly concerning impurity limits or GMP standards, can necessitate costly process modifications for API manufacturers.
• Intellectual Property: While the originator patent for oxaliplatin has expired, there can be ongoing patent litigation related to specific polymorphic forms or manufacturing processes that could impact generic market entry or supply.
• Quality Failures: A single quality issue at an API manufacturing site can lead to product recalls, regulatory sanctions, and significant supply chain disruption for multiple finished drug product manufacturers.
• Capacity Constraints: The specialized nature of platinum-based API manufacturing means that sudden increases in demand can strain existing production capacity, leading to shortages.

Mitigation strategies include multi-sourcing of critical raw materials and APIs, establishing strong supplier relationships with robust quality agreements, and maintaining adequate inventory buffers.

What are the future trends impacting the oxaliplatin supply chain?

Several trends are shaping the future of oxaliplatin supply and manufacturing.

• Increased Generic Competition: As more generic versions enter the market, pricing pressure will intensify, potentially leading to consolidation among API suppliers and a greater focus on cost-efficient manufacturing.
• Geographic Diversification: To mitigate risks associated with single-region dependency, there may be a trend towards establishing or qualifying API manufacturing capacity in a wider range of geographic locations.
• Technological Advancements in Synthesis: Research into more efficient and environmentally friendly synthesis routes for platinum-based compounds could emerge, although adoption in a highly regulated generic market can be slow.
• Supply Chain Transparency and Traceability: Growing demand for end-to-end supply chain visibility, driven by regulatory initiatives and patient safety concerns, will require enhanced data management and tracking capabilities from API to finished product.
• Focus on Sustainability: Pharmaceutical manufacturing is increasingly scrutinized for its environmental impact. Future trends may include a push for greener chemical processes and more sustainable sourcing of raw materials.

These trends will influence sourcing strategies, investment in manufacturing capabilities, and the overall competitive landscape for oxaliplatin.

Key Takeaways

• The oxaliplatin API market is dominated by a few key manufacturers, primarily located in China and India, requiring robust supply chain due diligence.
• Manufacturing oxaliplatin involves complex chemical synthesis and stringent quality control to meet pharmaceutical standards, posing significant barriers to entry.
• Finished dosage form manufacturing includes both originator (Sanofi) and numerous generic companies, leading to competitive pricing and broad market access.
• Regulatory compliance, including DMF/CEP submissions and GMP adherence, is critical for API suppliers and finished product manufacturers.
• Supply chain risks include geopolitical factors, raw material dependency, quality failures, and potential capacity constraints, necessitating risk mitigation strategies.
• Future trends point towards increased generic competition, potential geographic diversification of manufacturing, and a greater emphasis on supply chain transparency and sustainability.

Frequently Asked Questions

• Q1: What is the typical lead time for securing a new oxaliplatin API supplier? A new oxaliplatin API supplier typically requires 12-24 months to onboard. This duration accounts for supplier qualification, initial batch testing, review of Drug Master Files (DMFs) or Certificates of Suitability (CEPs), and regulatory audits.
• Q2: How does the price of platinum metal impact oxaliplatin API costs? The price of platinum metal is a significant cost driver for oxaliplatin API. Fluctuations in the global platinum market can directly influence raw material costs and, consequently, the final API price.
• Q3: Are there alternative platinum-based chemotherapy drugs that compete directly with oxaliplatin? Yes, carboplatin and cisplatin are other platinum-based chemotherapy drugs that are used in various cancer treatment regimens and may compete with oxaliplatin depending on the specific indication.
• Q4: What is the shelf life of oxaliplatin API and finished drug product? Oxaliplatin API typically has a shelf life of 2-3 years under specified storage conditions. Finished oxaliplatin injectable solutions generally have a shelf life of 24-36 months when stored appropriately, as validated during product development and reviewed by regulatory agencies.
• Q5: Can oxaliplatin API be sourced from countries outside of China and India? While China and India are dominant, oxaliplatin API can also be sourced from other regions. Companies in Bangladesh (e.g., Beacon Pharmaceuticals) and established global players like Teva (Israel) also manufacture and supply the API. However, the volume and market share from these alternative sources may be smaller.

Citations

[1] Sanofi. (n.d.). Eloxatin Prescribing Information. Retrieved from [Manufacturer's official website or FDA database for prescribing information] [2] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from [FDA website on DMFs] [3] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP). Retrieved from [EDQM website on CEPs] [4] Various Pharmaceutical Industry Reports. (Ongoing). Market analysis and supplier directories for active pharmaceutical ingredients. [5] Publicly available company reports and regulatory filings from manufacturers such as Hengrui Medicine, Teva Pharmaceutical Industries, Cipla Limited, Accord Healthcare, and Fresenius Kabi.