How to Source Nifurtimox for Pharmaceutical Formulation
Nifurtimox (Tablet, 30 mg, 120 mg) is classified under Anti Viral. It is therapeutically aligned with reference brands such as Lampit (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Nifurtimox for formulation, R&D, or bulk manufacturing.
Product Overview:
Nifurtimox is an antiprotozoal medicine used to treat parasitic infections, including Chagas disease and African trypanosomiasis (sleeping sickness). It works by generating toxic radicals inside the parasite, damaging its DNA and killing it.
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
Nifurtimox 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 Nifurtimox 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 Nifurtimox is more than procurement—it’s a strategic partnership. With its tablet form and 30 mg, 120 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 Nifurtimox.
Frequently Asked Questions For Sourcing of Nifurtimox
What is the typical lead time for Nifurtimox?
Lead times range from 4–6 weeks depending on supplier and region.
Is Nifurtimox available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Nifurtimox require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Nifurtimox?
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 Nifurtimox?
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 Nifurtimox?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Nifurtimox suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Nifurtimox be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.