How to Source Follitropin Alfa (recombinant FSH) for Pharmaceutical Formulation
Follitropin Alfa (recombinant FSH) (Prefilled Pen/Vial, 50 IU, 75 IU, 100 IU, 150 IU, 200 IU, 300 IU, 450 IU, 900 IU) is classified under Women's Health. It is therapeutically aligned with reference brands such as Gonal-f® (EU & US), Ovaleap®, Bemfola®(EU), Follistim AQ®(US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Follitropin Alfa (recombinant FSH) for formulation, R&D, or bulk manufacturing.
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
Follitropin Alfa (recombinant FSH) 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 Follitropin Alfa (recombinant FSH) 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 Follitropin Alfa (recombinant FSH) is more than procurement—it’s a strategic partnership. With its prefilled pen/vial form and 50 IU, 75 IU, 100 IU, 150 IU, 200 IU, 300 IU, 450 IU, 900 IU 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 Follitropin Alfa (recombinant FSH)
What is the typical lead time for Follitropin Alfa (recombinant FSH)?
Lead times range from 4–6 weeks depending on supplier and region.
Is Follitropin Alfa (recombinant FSH) available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Follitropin Alfa (recombinant FSH) require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Follitropin Alfa (recombinant FSH)?
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 Follitropin Alfa (recombinant FSH)?
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 Follitropin Alfa (recombinant FSH)?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Follitropin Alfa (recombinant FSH) suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Follitropin Alfa (recombinant FSH) 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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