How to Source Lusutrombopag for Pharmaceutical Formulation
Lusutrombopag (Tablets, 3 mg) is classified under Blood Disorder. It is therapeutically aligned with reference brands such as Mulpleta (USA), Mulpleo (EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Lusutrombopag for formulation, R&D, or bulk manufacturing.
Product Overview:
Lusutrombopag is an orally administered thrombopoietin receptor agonist used to treat thrombocytopenia (low platelet count) in adults with chronic liver disease who are scheduled for an invasive procedure. It stimulates bone marrow to produce more platelets, helping reduce bleeding risk. Lusutrombopag tablets are typically taken once daily for a short course before the scheduled procedure. The most common side effect reported is headache. It represents a targeted approach to safely elevate platelet counts before medical or dental procedures.
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
Lusutrombopag 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 Lusutrombopag 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 Lusutrombopag is more than procurement—it’s a strategic partnership. With its tablets form and 3 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.
Next Step: Get expert assistance in sourcing Lusutrombopag.
Frequently Asked Questions For Sourcing of Lusutrombopag
What is the typical lead time for Lusutrombopag?
Lead times range from 4–6 weeks depending on supplier and region.
Is Lusutrombopag available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Lusutrombopag require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Lusutrombopag?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Lusutrombopag?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Lusutrombopag?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Lusutrombopag suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Lusutrombopag be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.