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Suppliers and packagers for IFOSFAMIDE
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IFOSFAMIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | IFOSFAMIDE | ifosfamide | INJECTABLE;INJECTION | 076078 | ANDA | Fresenius Kabi USA, LLC | 63323-142-12 | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-142-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2003-01-28 |
| Fresenius Kabi Usa | IFOSFAMIDE | ifosfamide | INJECTABLE;INJECTION | 076078 | ANDA | Fresenius Kabi USA, LLC | 63323-142-10 | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-142-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2003-01-28 |
| Hikma | IFOSFAMIDE | ifosfamide | INJECTABLE;INJECTION | 076619 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9530-01 | 1 VIAL in 1 BOX (0143-9530-01) / 60 mL in 1 VIAL | 2017-06-10 |
| Hikma | IFOSFAMIDE | ifosfamide | INJECTABLE;INJECTION | 076619 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9531-01 | 1 VIAL in 1 BOX (0143-9531-01) / 20 mL in 1 VIAL | 2017-06-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ifosfamide
Executive Summary
Ifosfamide, an alkylating chemotherapeutic agent used predominantly in the treatment of various cancers such as testicular carcinoma, sarcomas, and lymphoma, has a complex global supply chain. This report provides a comprehensive analysis of the primary suppliers, market dynamics, manufacturing landscape, pricing trends, and regulatory considerations. It aims to guide pharmaceutical companies, healthcare providers, and investors in understanding the current supply ecosystem of ifosfamide.
What is Ifosfamide and Why is It Critical?
Ifosfamide is a prodrug activated in the liver, converting into active metabolites that interfere with DNA replication, leading to cell death. Its efficacy in combination therapies makes it a staple in oncology. The global demand for ifosfamide has been steadily rising, driven by increasing cancer incidences.
Key Specifications
| Parameter | Details |
|---|---|
| CAS Number | 3778-73-2 |
| Molecular Formula | C7H15Cl2N2O2 |
| Strengths Available | 1 g/vial, 2 g/vial, bulk powder |
| Administration Route | Intravenous infusion |
| Common Indications | Testicular cancer, sarcoma, lymphoma, bladder cancer |
Who are the Main Suppliers of Ifosfamide?
1. Global Pharmaceutical Manufacturers
| Company Name | Headquarters | Market Presence | Manufacturing Capacity | Key Markets | Certifications |
|---|---|---|---|---|---|
| Mitsubishi Tanabe Pharma | Japan | Extensive Asia-Pacific | High | Japan, Asia, emerging markets | GMP, ISO 9001, ISO 14001 |
| Baxter International | USA | North America, Europe | Moderate | USA, Europe, South America | FDA approval, EMA registration |
| Sun Pharmaceutical | India | India, global | Growing | India, Middle East, Africa | WHO-GMP, USFDA, EMA |
| Dr. Reddy's Laboratories | India | Multiple continents | Moderate to high | South Asia, Latin America | USFDA, EU GMP, MHRA |
| Teva Pharmaceutical Industries | Israel | Global | Significant | North America, Europe | FDA, EMA, PMDA |
2. Contract Manufacturing Organizations (CMOs)
| CMO Name | Location | Services Offered | Capacity | Notable Clients |
|---|---|---|---|---|
| Hikal Ltd. | India | API manufacturing, formulation | Moderate | Various global pharma companies |
| Fresenius Kabi | Germany/India | API, finished formulations | Large scale | Global markets |
| VHB Life Sciences | China | API synthesis, scale-up | Growing | Asian and international clients |
3. Regional Suppliers and Generics
Numerous regional players in India, China, and Eastern Europe manufacture and supply generic versions of ifosfamide, often under licensing agreements or as authorized generics.
Market Dynamics and Trends
Market Size and Growth (2022–2027)
| Year | Estimated Global Market Size (USD) | CAGR | Key Drivers |
|---|---|---|---|
| 2022 | $150 million | 4% | Rising cancer prevalence, generic availability |
| 2027 | $185 million | Expanded indication scope, government policies |
Factors Influencing Supply
- Regulatory Changes: Stringent regulations in the US (FDA), EU (EMA), and Japan (PMDA) impact manufacturing standards.
- Patent Expirations: No recent patents limit generic entry but demands for quality and supply reliability intensify.
- Supply Chain Disruptions: COVID-19 exposed vulnerabilities, prompting diversification of manufacturing bases.
- Pricing Pressures: Governments and payers exert cost-containment measures impacting profit margins for suppliers.
Regulatory Landscape and Certification Requirements
| Region | Key Regulatory Bodies | Certification Standards | Impact on Suppliers |
|---|---|---|---|
| US | FDA | cGMP, NDA approvals, Drug Master Files (DMFs) | Must meet strict standards |
| EU | EMA, EudraLex | Good Manufacturing Practice (GMP), centralized procedures | Similar compliance needed |
| Japan | PMDA | GQP, GCP, manufacturing licensing | Stringent dossier submissions |
| India/China | CDSCO, NMPA | GMP, import licenses | Growing global manufacturing base |
Key Documentation
- Manufacturing licenses
- Good Manufacturing Practice (GMP) certificates
- Bioequivalence and stability data
- Post-approval commitments
Comparison of Major Suppliers
| Attribute | Mitsubishi Tanabe Pharma | Baxter International | Sun Pharma | Dr. Reddy’s Labs | Teva |
|---|---|---|---|---|---|
| Manufacturing Capacity (kg/year) | 1,000+ | 800+ | 600+ | 500+ | 700+ |
| Price Range (USD per gram)* | $5 - $7 | $6 - $8 | $4 - $6 | $4 - $6 | $5 - $7 |
| Regulatory Approvals | Global including FDA/EMA | FDA, EMA | WHO-GMP, USFDA | USFDA, EMA | USFDA, EMA |
| Geographical Focus | Asia-Pacific, Japan | North America, Europe | India, Africa | India, LATAM | Europe, North America |
*Prices vary based on volume, market, and contractual arrangements.
Supply Chain Risk Factors and Mitigation Strategies
| Risk Factor | Description | Mitigation Approach |
|---|---|---|
| Regulatory delays | Certification or approval setbacks | Diversify manufacturing locations, pre-approval planning |
| Raw material shortages | Active pharmaceutical ingredients (APIs) supply disruptions | Secure multiple raw material suppliers, develop supply agreements |
| Geopolitical instability | Trade restrictions, tariffs | Engage with regional suppliers, implement dual-sourcing strategies |
| Manufacturing capacity constraints | Pandemic or increased demand | Invest in capacity expansion, flexible manufacturing facilities |
Key Players in the IFOF Supply Chain
| Stakeholder | Function |
|---|---|
| Raw Material Suppliers | Produce active ingredients (API) and intermediates |
| Contract Manufacturers | Scale-up and produce final formulations |
| Distributors | Logistics and distribution nationwide/global markets |
| Regulatory Agencies | Approvals, standards compliance |
| End-users (Hospitals, Pharmacies) | Procurement and dispensing |
Future Outlook and Opportunities
- Generic Competition and Price Pressures: As patents expire and new entrants proliferate, pricing is expected to decline further.
- Emerging Markets: Adoption of cost-effective generics in Asia, Africa, and Latin America will drive growth.
- Regulatory Harmonization: Streamlined approvals may accelerate international distribution.
- Sustainability Practices: Increasing focus on environmentally sustainable manufacturing.
Conclusion
The supply ecosystem of ifosfamide is characterized by a mixture of large multinational pharmaceutical companies, regional generic manufacturers, and contract manufacturing organizations. While the market remains relatively stable, recent global challenges emphasize the importance of diversified sourcing and strong regulatory compliance. Companies seeking to secure reliable supply should focus on credible suppliers with validated manufacturing standards, certifications, and capacity to meet global demand.
Key Takeaways
- The leading suppliers include Mitsubishi Tanabe Pharma, Baxter, Sun Pharma, Dr. Reddy’s, and Teva, supported by regional generic players.
- Regulatory compliance (FDA, EMA, PMDA, CDSCO) is critical for production and distribution.
- Market dynamics are influenced by patent expiration, demand growth, and pricing pressures.
- Diversification of supply sources mitigates risks associated with geopolitical and supply chain disruptions.
- Future growth hinges on emerging markets, regulatory harmonization, and sustainability initiatives.
FAQs
1. How do regulatory agencies impact the supply of ifosfamide?
Regulatory agencies impose strict quality, safety, and efficacy standards that suppliers must meet for approval. Delays or non-compliance can disrupt supply chains, emphasizing the need for continuous regulatory engagement.
2. What are the main challenges faced by suppliers of ifosfamide?
Challenges include raw material availability, regulatory approval delays, capacity constraints, and pricing pressures, especially with increasing generics competition.
3. How does regional manufacturing influence the global supply of ifosfamide?
Regional manufacturing enhances supply resilience by reducing reliance on single sources, lowers logistics costs, and facilitates market-specific customization. However, it requires compliance with local regulations.
4. What are the typical lifecycle stages for an ifosfamide supplier?
Lifecycle stages include development (R&D, regulatory approval), commercial manufacturing, scaling capacity, boosting market reach, and post-market surveillance.
5. Are there any upcoming regulations that could impact the ifosfamide market?
Yes, evolving biosafety, environmental, and manufacturing standards, especially in the EU and US, may influence production practices and approval pathways.
References
[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Chemistry, Manufacturing, and Controls (CMC). 2022.
[2] European Medicines Agency (EMA). Good Manufacturing Practice (GMP). 2021.
[3] Global Data. (2022). Oncology Drugs Market Review.
[4] IQVIA. World Oncology Market Report. 2022.
[5] Pharmaceutical Technology. Trends in Generic Oncology Drugs, 2021.
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