How to Source Cytarabine IV/SQ/Intrathecal Injection for Pharmaceutical Formulation

Cytarabine IV/SQ/Intrathecal Injection (Injection, 100 mg/mL(IV & SQ); 50 mg/mL(intrathecal use)) is classified under Blood Disorder. It is therapeutically aligned with reference brands such as DepoCyt(US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Cytarabine IV/SQ/Intrathecal Injection for formulation, R&D, or bulk manufacturing.

Product Overview: Cytarabine inhibits DNA synthesis by incorporating into DNA strands, disrupting cell replication. It effectively treats leukemia and lymphoma by targeting rapidly dividing cancer cells. Benefits include rapid tumor reduction, improved remission rates, and enhanced survival, making it a key chemotherapeutic agent in hematologic malignancies.

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 IV/SQ/Intrathecal Injection 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 IV/SQ/Intrathecal Injection 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 IV/SQ/Intrathecal Injection is more than procurement—it’s a strategic partnership. With its injection form and 100 mg/mL(IV & SQ); 50 mg/mL(intrathecal use) 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 Cytarabine IV/SQ/Intrathecal Injection