How to Source Ixabepilone for Pharmaceutical Formulation
Ixabepilone (Injection, 15 mg, 45mg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Ixempra (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Ixabepilone for formulation, R&D, or bulk manufacturing.
Product Overview:
Ixabepilone is a semisynthetic epothilone analog used in the treatment of locally advanced or metastatic breast cancer. It works by stabilizing microtubules and preventing cancer cell division. It is mainly used in patients who have progressed on anthracyclines and taxanes. It is administered as an intravenous infusion.
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
Ixabepilone 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 Ixabepilone 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 Ixabepilone is more than procurement—it’s a strategic partnership. With its injection form and 15 mg, 45mg 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.
Next Step: Get expert assistance in sourcing Ixabepilone.
Frequently Asked Questions For Sourcing of Ixabepilone
What is the typical lead time for Ixabepilone?
Lead times range from 4–6 weeks depending on supplier and region.
Is Ixabepilone available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Ixabepilone require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Ixabepilone?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Ixabepilone?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Ixabepilone?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Ixabepilone suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Ixabepilone be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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