How to Source Clotrimazole Vaginal Tablets/Cream for Pharmaceutical Formulation
Clotrimazole Vaginal Tablets/Cream (Vaginal Tablets/Cream, 10 mg, 100 mg, 200 mg (vaginal tablets), 1% (cream)) is classified under Anti-fungal. It is therapeutically aligned with reference brands such as Mycelex(US); Fungusil(EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Clotrimazole Vaginal Tablets/Cream for formulation, R&D, or bulk manufacturing.
Product Overview:
Clotrimazole vaginal tablets and cream inhibit fungal cytochrome P450 14α-demethylase, disrupting ergosterol synthesis and damaging fungal cell membranes. They effectively treat vaginal candidiasis, offering benefits like targeted therapy, rapid symptom relief, broad antifungal activity, minimal systemic absorption, and high safety, making them a reliable choice for vaginal fungal infections.
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
Clotrimazole Vaginal Tablets/Cream 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 Clotrimazole Vaginal Tablets/Cream 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 Clotrimazole Vaginal Tablets/Cream is more than procurement—it’s a strategic partnership. With its vaginal tablets/cream form and 10 mg, 100 mg, 200 mg (vaginal tablets), 1% (cream) 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 Clotrimazole Vaginal Tablets/Cream.
Frequently Asked Questions For Sourcing of Clotrimazole Vaginal Tablets/Cream
What is the typical lead time for Clotrimazole Vaginal Tablets/Cream?
Lead times range from 4–6 weeks depending on supplier and region.
Is Clotrimazole Vaginal Tablets/Cream available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Clotrimazole Vaginal Tablets/Cream require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Clotrimazole Vaginal Tablets/Cream?
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 Clotrimazole Vaginal Tablets/Cream?
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 Clotrimazole Vaginal Tablets/Cream?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Clotrimazole Vaginal Tablets/Cream suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Clotrimazole Vaginal Tablets/Cream be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.