How to Source Osilodrostat for Pharmaceutical Formulation
Osilodrostat (Tablets, 1mg, 5mg, 10mg) is classified under Critical Care. It is therapeutically aligned with reference brands such as Isturisa (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Osilodrostat for formulation, R&D, or bulk manufacturing.
Product Overview:
Osilodrostat is a cortisol synthesis inhibitor used to treat endogenous Cushing’s syndrome. It works by blocking 11β-hydroxylase, an enzyme required for cortisol production, helping restore hormonal balance. It offers an effective oral option for patients who cannot undergo surgery or need medical control before or after surgical intervention.
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
Osilodrostat 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 Osilodrostat 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 Osilodrostat is more than procurement—it’s a strategic partnership. With its tablets form and 1mg, 5mg, 10mg 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 Osilodrostat.
Frequently Asked Questions For Sourcing of Osilodrostat
What is the typical lead time for Osilodrostat?
Lead times range from 4–6 weeks depending on supplier and region.
Is Osilodrostat available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Osilodrostat require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Osilodrostat?
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 Osilodrostat?
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 Osilodrostat?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Osilodrostat suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Osilodrostat 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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