How to Source Givinostat for Pharmaceutical Formulation

Givinostat (Oral suspension, 8.86 mg/mL) is classified under Neurology. It is therapeutically aligned with reference brands such as Duvyzat (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Givinostat for formulation, R&D, or bulk manufacturing.

Product Overview: Givinostat is a histone deacetylase (HDAC) inhibitor which works by inhibiting class I and II HDAC enzymes, reducing inflammation, muscle degeneration and fibrosis in patients with Duchenne muscular dystrophy. It is indicated for patients aged 6 years and older with DMD, regardless of specific genetic variant. The medication is given as a twice daily oral suspension with food, and requires monitoring of blood counts and triglycerides due to risks of thrombocytopenia and hypertriglyceridaemia.

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

Givinostat 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 Givinostat 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 Givinostat is more than procurement—it’s a strategic partnership. With its oral suspension form and 8.86 mg/mL 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 Givinostat