How to Source Mifepristone for Pharmaceutical Formulation
Mifepristone (Tablets, 200 mg, 300 mg) is classified under Women's Health. It is therapeutically aligned with reference brands such as Mifeprex (USA), Mifegyne (EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Mifepristone for formulation, R&D, or bulk manufacturing.
Product Overview:
Mifepristone is an oral medication used for medical termination of early pregnancy and for the management of hypercortisolism in specific medical conditions. It works by blocking progesterone, a hormone essential for pregnancy continuation. Mifepristone is typically used together with misoprostol for medical abortion protocols. In some regions, it is also approved for treatment of Cushing’s syndrome due to its glucocorticoid receptor blockade.
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
Mifepristone 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 Mifepristone 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 Mifepristone is more than procurement—it’s a strategic partnership. With its tablets form and 200 mg, 300 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 Mifepristone.
Frequently Asked Questions For Sourcing of Mifepristone
What is the typical lead time for Mifepristone?
Lead times range from 4–6 weeks depending on supplier and region.
Is Mifepristone available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Mifepristone require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Mifepristone?
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 Mifepristone?
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 Mifepristone?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Mifepristone suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Mifepristone 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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