How to Source Avatrombopag maleate for Pharmaceutical Formulation
Avatrombopag maleate (Tablets, 20mg) is classified under Blood Disorder. It is therapeutically aligned with reference brands such as Doptelet (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Avatrombopag maleate for formulation, R&D, or bulk manufacturing.
Product Overview:
Avatrombopag is an oral thrombopoietin (TPO) receptor agonist that stimulates megakaryocyte proliferation and differentiation, thereby increasing platelet production. It is indicated for adult patients with thrombocytopenia due to chronic liver disease who are scheduled for an invasive procedure, and also for chronic immune thrombocytopenia (ITP) when other treatments are insufficient.
It helps avoid platelet transfusions and reduce bleeding risk by raising platelet counts prior to 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
Avatrombopag maleate 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 Avatrombopag maleate 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 Avatrombopag maleate is more than procurement—it’s a strategic partnership. With its tablets form and 20mg 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 Avatrombopag maleate.
Frequently Asked Questions For Sourcing of Avatrombopag maleate
What is the typical lead time for Avatrombopag maleate?
Lead times range from 4–6 weeks depending on supplier and region.
Is Avatrombopag maleate available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Avatrombopag maleate require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Avatrombopag maleate?
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 Avatrombopag maleate?
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 Avatrombopag maleate?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Avatrombopag maleate suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Avatrombopag maleate be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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