How to Source Azacitidine Injection for Pharmaceutical Formulation

Azacitidine Injection (Injectable, 100 mg/vial) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Vidaza®(EU & US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Azacitidine Injection for formulation, R&D, or bulk manufacturing.

Product Overview: Azacitidine 50 mg and 100 mg Vials (brand name Vidaza®) are used in oncology to treat myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). As a hypomethylating agent, Azacitidine works by inhibiting DNA methylation, promoting the reactivation of genes that control blood cell growth. Available as subcutaneous or intravenous injections, it is vital for patients who are ineligible for intensive chemotherapy.

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

Azacitidine 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 Azacitidine 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 Azacitidine Injection is more than procurement—it’s a strategic partnership. With its injectable form and 100 mg/vial 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 Azacitidine Injection