How to Source Cyclophosphamide for Pharmaceutical Formulation

Cyclophosphamide (Oral Tablet & Injection:, Injection: 200 mg/2 mL (vial), 500 mg/5 mL (vial); Tablet: 25 mg, 50 mg ,100 mg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Cytoxan®(US & EU), Endoxan®(EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Cyclophosphamide for formulation, R&D, or bulk manufacturing.

Product Overview: Cyclophosphamide is an intravenous chemotherapy drug used for breast cancer, ovarian cancer, non-Hodgkin lymphoma, leukemia, and autoimmune diseases. Available in IV (200 mg/2 mL, 500 mg/5 mL) and oral tablet (25 mg, 50 mg, 100 mg) formulations in the US and EU. Cyclophosphamide, marketed as Cytoxan® (US) and Endoxan® (EU), is a chemotherapy agent widely used i...

1. Regulatory Compliance & Documentation

Ensure suppliers provide:

• ✔ Valid DMF (Drug Master File)
• ✔ COA (Certificate of Analysis) for each batch
• ✔ GMP, ISO, or ICH Q7 compliance certificates

2. Purity, Grade & Specification Matching

Cyclophosphamide must meet exact grade and purity for your dosage form:

• ✔ USP / EP / JP grade verification
• ✔ Particle size distribution check
• ✔ Residual solvent and heavy metal limits

3. Supplier Reliability & Audit History

• ✔ Positive past audit reports
• ✔ Pharma client references
• ✔ Years of proven API manufacturing experience

4. Commercial Terms: Pricing, MOQ & Flexibility

• ✔ Transparent pricing
• ✔ Pilot batch MOQ flexibility
• ✔ Volume-based discounts

5. Lead Time, Inventory & Logistics

Typical lead time for Cyclophosphamide is 4–6 weeks.

• ✔ Emergency dispatch options
• ✔ Regional warehousing
• ✔ Special storage if needed

6. Formulation Support

• ✔ Technical datasheets
• ✔ Sample availability
• ✔ Stability study support

Conclusion

Sourcing Cyclophosphamide is more than procurement—it’s a strategic partnership. With its oral tablet & injection: form and Injection: 200 mg/2 mL (vial), 500 mg/5 mL (vial); Tablet: 25 mg, 50 mg ,100 mg specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.

Frequently Asked Questions For Sourcing of Cyclophosphamide