Bulk Pharmaceutical API Sources for CYTOXAN (LYOPHILIZED)

Bulk Pharmaceutical API Sources for CYTOXAN (LYOPHILIZED)

Vendor	Vendor Homepage	Vendor Sku	API Url
Vitas-M Laboratory		STK177249
Molport		MolPort-001-783-420
TCI (Tokyo Chemical Industry)		C2236
Enamine		EN300-74526
AKos Consulting & Solutions		AKOS005410738

Bulk Active Pharmaceutical Ingredient (API) Sources for: CYTOXAN (LYOPHILIZED)

Last updated: July 27, 2025

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Overview

Cytoxan, the brand name for cyclophosphamide, is a nitrogen mustard alkylating agent widely used in oncology and immunosuppressive therapies. Its lyophilized formulation necessitates high-quality bulk API sourcing for pharmaceutical manufacturers, ensuring efficacy, safety, and compliance with regulatory standards. Reliable suppliers of cyclophosphamide API are critical for pharmaceutical companies aiming to produce Cytoxan (Lyophilized) with consistent quality.

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Understanding Cyclophosphamide as an API

Cyclophosphamide is a prodrug activated in the liver, transforming into active metabolites that interfere with DNA replication and cell division. Its synthesis involves complex chemical processes, requiring high purity standards aligned with pharmacopeial specifications such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP).

The API must meet rigorous quality criteria, including assay purity, impurity profile, molecular weight verification, residual solvents, and sterility standards for lyophilized formulations, especially for injectable products like Cytoxan.

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Key Criteria for API Suppliers of Cyclophosphamide

• Manufacturing Capacity & Expertise: Proven capability for large-scale production conforming to current Good Manufacturing Practices (cGMP).
• Quality Assurance & Control: Comprehensive testing, including HPLC, residual solvents, endotoxin limits, and stability data.
• Regulatory Compliance: Approved or registered in major regulatory jurisdictions; compliant with ICH guidelines.
• Traceability & Documentation: Complete batch records, Certificates of Analysis (CoA), and stability data.
• Pricing & Lead Times: Competitive pricing with assured supply chain reliability.

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Major Global Suppliers of Cyclophosphamide API

1. Baxter International Inc.

Overview: Baxter is a leading global supplier of pharmaceutical ingredients, including chemotherapy APIs. Its cyclophosphamide API is produced under strict cGMP conditions, with extensive regulatory approvals worldwide.

Strengths: Consistent quality, comprehensive documentation, and global distribution infrastructure.

Regulatory Status: Approved by FDA, EMA, and other major agencies; suitable for injectable and lyophilized formulations.

2. Fresenius Kabi

Overview: Recognized for high-quality active pharmaceutical ingredients, Fresenius Kabi supplies cyclophosphamide API to various markets, focusing on oncology and injectable formulations.

Strengths: Strong manufacturing footprint in Europe and Asia; dedicated to cGMP standards.

Certifications: EMA-approved; compliant with global pharmaceutical quality standards.

3. Sun Pharmaceutical Industries Ltd.

Overview: India-based Sun Pharma offers cyclophosphamide API as part of its extensive oncology anticancer portfolio.

Strengths: Cost-effective manufacturing; robust quality systems; compliant with international standards.

Regulatory Reach: Approved by Indian regulators and exported to several countries, including the US and Europe.

4. Jiangsu Hengrui Medicine Co., Ltd.

Overview: A leading Chinese pharmaceutical firm specializing in oncology APIs, including cyclophosphamide.

Strengths: Strong R&D capabilities and manufacturing capacity; competitive pricing.

Compliance: Meets ISO and GMP standards; increasing regulatory acceptance globally.

5. Sichuan Kelun Pharmaceutical Co., Ltd.

Overview: A major Chinese pharmaceutical producer with certified facilities capable of supplying cyclophosphamide API.

Strengths: Extensive Asian market presence; high-quality manufacturing footprint.

Regulatory Work: Gaining approvals beyond China, targeting global markets.

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Emerging and Contract API Manufacturers

Apart from established pharmaceutical companies, several Contract Manufacturing Organizations (CMOs) offer cyclophosphamide API with cGMP certification. These include:

• Hubei Wudang Pharmaceutical Co., Ltd.
• Zhejiang NHU Co., Ltd.
• Hainan Tianyu Pharmaceutical Co., Ltd.

They provide flexible supply options, often at competitive prices, with capacity for large-scale production.

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Quality and Regulatory Considerations

For Cytoxan (Lyophilized), API quality directly impacts the final product's safety and efficacy. The selection process should prioritize suppliers with:

• Validated manufacturing processes adhering to cGMP.
• Certificates of analysis demonstrating compliance with pharmacopeial standards.
• Proven traceability, batch reproducibility, and stability data.
• Technical support for scale-up, formulation, and regulatory submissions.

Regulatory agencies such as the FDA, EMA, and PMDA require comprehensive documentation and validation studies when sourcing APIs internationally.

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Supply Chain and Risk Management

Given the Criticality of cytophosphamide in chemotherapeutic regimens, ensuring uninterrupted supply is paramount. Diversification of suppliers, establishing reliable contractual agreements, and inventory buffering mitigate potential supply chain disruptions.

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Pricing Dynamics and Market Trends

API pricing is influenced by raw material costs, manufacturing complexity, regulatory compliance, and geopolitical factors. Chinese and Indian API manufacturers generally offer competitive prices, but quality assurance and regulatory documentation are decisive factors beyond cost considerations.

Recent market trends indicate a shift towards more rigorous regulatory scrutiny of foreign API suppliers, emphasizing quality standards equivalence and robust supply chain security. Transparent validation records and compliance documentation enhance supplier credibility.

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Conclusion

Sourcing high-quality cyclophosphamide API for Lyophilized Cytoxan involves balancing factors such as manufacturing capacity, regulatory status, quality assurance, and supply chain reliability. Major global suppliers like Baxter, Fresenius Kabi, and burgeoning Chinese manufacturers are prominent options, with numerous contract manufacturing options to meet specific supply and pricing needs. Proper due diligence, adherence to regulatory standards, and proactive supply chain management are crucial for successful API procurement.

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Key Takeaways

• Prioritize cGMP-certified suppliers with proven regulatory acceptance and robust quality systems.
• Diversify suppliers to mitigate supply chain risks inherent in international API sourcing.
• Ensure thorough documentation and compliance with pharmacopoeial standards for API batches.
• Engage in early qualification and validation processes for new suppliers.
• Monitor geopolitical and regulatory developments that could impact API availability and pricing.

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FAQs

1. What quality standards should I verify when sourcing cyclophosphamide API for Cytoxan?
Ensure the API meets pharmacopeial standards such as USP or EP, with comprehensive Certificates of Analysis, and complies with cGMP and relevant regulatory requirements for injectable products.

2. How does the choice of API supplier impact the final Cytoxan product?
The supplier’s quality assurance, manufacturing practices, and regulatory compliance directly influence drug safety, efficacy, batch consistency, and regulatory approval processes.

3. Are Chinese and Indian suppliers reliable for cyclophosphamide API?
Yes, many Chinese and Indian manufacturers produce cyclophosphamide API under cGMP standards, with increasing regulatory acceptance worldwide. Rigorous qualification and validation are essential when partnering with these sources.

4. What risks are associated with foreign API sourcing, and how can they be mitigated?
Risks include supply disruptions, quality variability, and regulatory hurdles. Mitigate these by establishing multiple qualified suppliers, conducting audits, and maintaining safety stock inventories.

5. How does regulatory approval influence API selection for international markets?
Regulatory approval or registration by agencies like FDA or EMA facilitates smoother registration of finished products, reduces legal risks, and assures compliance with strict API quality standards.

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Sources:

[1] U.S. Pharmacopeia. Cyclophosphamide Monograph. 2022.
[2] European Pharmacopoeia. Cyclophosphamide Monograph. 2022.
[3] Baxter International. API product documentation. 2023.
[4] Fresenius Kabi Corporate Reports. 2023.
[5] Sun Pharmaceutical Industries Ltd. Product catalog. 2023.