How to Source Dordaviprone hydrochloride for Pharmaceutical Formulation

Dordaviprone hydrochloride (Capsules, 125 mg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Modeyso (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Dordaviprone hydrochloride for formulation, R&D, or bulk manufacturing.

Product Overview: Dordaviprone (Modeyso) is a novel targeted anticancer medication used to treat diffuse midline glioma with an H3 K27M mutation in adults and children aged 1 year and older. It works by activating mitochondrial protease ClpP and inhibiting dopamine D2 receptors to disrupt tumor growth. This drug is orally administered once weekly as a capsule. It received accelerated FDA approval in 2025 for patients whose disease has progressed after prior therapy. The therapy represents the first systemic option for this rare and aggressive brain tumor.

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

Dordaviprone hydrochloride 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 Dordaviprone hydrochloride 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 Dordaviprone hydrochloride is more than procurement—it’s a strategic partnership. With its capsules form and 125 mg 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 Dordaviprone hydrochloride