How to Source Valbenazine for Pharmaceutical Formulation

Valbenazine (Capsules, 40 mg, 60 mg, 80 mg) is classified under Neurology. It is therapeutically aligned with reference brands such as Ingrezza (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Valbenazine for formulation, R&D, or bulk manufacturing.

Product Overview: Valbenazine is a selective vesicular monoamine transporter-2 (VMAT2) inhibitor that decreases excessive dopamine release in nerve endings, helping control involuntary movements. It is approved for treating tardive dyskinesia in adults and chorea associated with Huntington’s disease. The drug is taken once daily, either as a whole capsule or as a sprinkle formulation over soft food. Common side effects include drowsiness, dizziness, and dry mouth, and it may cause QT prolongation, so heart monitoring is needed. It is metabolized in the liver, so dose adjustments may be required in hepatic impairment.

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

Valbenazine 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 Valbenazine 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 Valbenazine is more than procurement—it’s a strategic partnership. With its capsules form and 40 mg, 60 mg, 80 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 Valbenazine