How to Source Dacarbazine for Pharmaceutical Formulation

Dacarbazine (IV Injection, 100 mg/vial, 200 mg/vial) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as DTIC-Dome®(EU & US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Dacarbazine for formulation, R&D, or bulk manufacturing.

Product Overview: Dacarbazine, branded as DTIC-Dome® (US) and available in generic form, is used to treat malignant melanoma, Hodgkin’s lymphoma, and soft tissue sarcoma. As an alkylating agent, it interferes with DNA replication, preventing cancer cell growth. Available in 100 mg and 200 mg vials for IV injection, Dacarbazine is sourced from GMP-compliant suppliers and is widely used in US and EU markets for oncology treatment. Dacarbazine, marketed as DTIC-Dome® (by Bristol-Myers Squibb) and available as a generic in the US a...

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

Dacarbazine 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 Dacarbazine 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 Dacarbazine is more than procurement—it’s a strategic partnership. With its iv injection form and 100 mg/vial, 200 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 Dacarbazine