How to Source Metronidazole + Miconazole nitrate for Pharmaceutical Formulation
Metronidazole + Miconazole nitrate (Vaginal suppository, 500 mg + 100 mg / 750mg+200mg) is classified under Anti-fungal. It is therapeutically aligned with reference brands such as Invel (USA/EU), Trimic, Inserdin. This guide highlights key sourcing factors buyers should consider when procuring high-quality Metronidazole + Miconazole nitrate for formulation, R&D, or bulk manufacturing.
Product Overview:
METRONIDAZOLE+MICONAZOLE is a combination medicine used to treat vaginal infections. Vaginal infection is the infection of the vagina and vulva (tissue at the opening of the vagina), which occurs due to the overgrowth of bacteria and fungi. Vaginal infection can cause inflammation, itchiness, thick discharge, change in colour of the discharge, burning sensation or pain during urination, vaginal bleeding or spotting, and pain during intercourse.
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
Metronidazole + Miconazole nitrate 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 Metronidazole + Miconazole nitrate 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 Metronidazole + Miconazole nitrate is more than procurement—it’s a strategic partnership. With its vaginal suppository form and 500 mg + 100 mg / 750mg+200mg 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 Metronidazole + Miconazole nitrate.
Frequently Asked Questions For Sourcing of Metronidazole + Miconazole nitrate
What is the typical lead time for Metronidazole + Miconazole nitrate?
Lead times range from 4–6 weeks depending on supplier and region.
Is Metronidazole + Miconazole nitrate available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Metronidazole + Miconazole nitrate require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Metronidazole + Miconazole nitrate?
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 Metronidazole + Miconazole nitrate?
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 Metronidazole + Miconazole nitrate?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Metronidazole + Miconazole nitrate suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Metronidazole + Miconazole nitrate be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.