How to Source Cytarabine + Daunorubicin liposomal for Pharmaceutical Formulation
Cytarabine + Daunorubicin liposomal (Liposomal injectable, 44mg/ 100 ml) is classified under Liposomal Drug Delivery. It is therapeutically aligned with reference brands such as Vyxeos. This guide highlights key sourcing factors buyers should consider when procuring high-quality Cytarabine + Daunorubicin liposomal for formulation, R&D, or bulk manufacturing.
Product Overview:
Cytarabine + Daunorubicin liposomal (Vyxeos) delivers targeted chemotherapy by encapsulating drugs in liposomes, increasing tumor cell uptake. It inhibits DNA synthesis and promotes cell death. Benefits include enhanced efficacy, reduced toxicity, and improved survival outcomes for acute myeloid leukemia (AML) patients, supporting personalized cancer therapy.
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
Cytarabine + Daunorubicin liposomal 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 Cytarabine + Daunorubicin liposomal 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 Cytarabine + Daunorubicin liposomal is more than procurement—it’s a strategic partnership. With its liposomal injectable form and 44mg/ 100 ml 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 Cytarabine + Daunorubicin liposomal.
Frequently Asked Questions For Sourcing of Cytarabine + Daunorubicin liposomal
What is the typical lead time for Cytarabine + Daunorubicin liposomal?
Lead times range from 4–6 weeks depending on supplier and region.
Is Cytarabine + Daunorubicin liposomal available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Cytarabine + Daunorubicin liposomal require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Cytarabine + Daunorubicin liposomal?
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 Cytarabine + Daunorubicin liposomal?
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 Cytarabine + Daunorubicin liposomal?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Cytarabine + Daunorubicin liposomal suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Cytarabine + Daunorubicin liposomal 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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