Bulk Pharmaceutical API Sources for GYNE-LOTRIMIN 3 COMBINATION PACK

Bulk Pharmaceutical API Sources for GYNE-LOTRIMIN 3 COMBINATION PACK

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C6019_SIGMA
Molport		MolPort-002-557-756
Hangzhou APIChem Technology		AC-279
Vitas-M Laboratory		STK700023
Amadis Chemical		A816789
AKos Consulting & Solutions		AKOS005607024
TimTec		ST50994242

Bulk Active Pharmaceutical Ingredient (API) Sources for GYNE-LOTRIMIN 3 COMBINATION PACK

Last updated: August 3, 2025

Introduction

The GYNE-LOTRIMIN 3 Combination Pack, widely prescribed for treating vulvovaginal candidiasis and other yeast infections, combines two active pharmaceutical ingredients (APIs): Clotrimazole and Miconazole. Both APIs are antifungal agents critical for efficacy, and sourcing high-quality bulk APIs is paramount for manufacturers aiming to ensure product safety, compliance, and market competitiveness. This report provides an exhaustive overview of reliable API sources for Clotrimazole and Miconazole, emphasizing global suppliers' credibility, quality standards, regulatory compliance, and strategic considerations for pharmaceutical companies.

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Active Pharmaceutical Ingredients in GYNE-LOTRIMIN 3

Clotrimazole

• Chemical Class: Azole antifungal
• Therapeutic Use: Topical treatment for fungal infections, including vulvovaginal candidiasis.
• Typical Concentration in Pack: 10 mg or equivalent per dose.

Miconazole

• Chemical Class: Azole antifungal
• Therapeutic Use: Used alongside Clotrimazole, particularly for resistant infections or mixed fungal flora.
• Typical Concentration in Pack: 100 mg per dose.

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Criteria for Selecting API Suppliers

When sourcing APIs for GYNE-LOTRIMIN 3, manufacturers prioritize the following criteria:

• Quality Assurance: GMP compliance, Certificates of Analysis (CoA), and batch consistency.
• Regulatory Approval: Approval status with major pharmacopeias (USP, EP, JP) and FDA adherence.
• Supply Capacity: Ability to meet demand, lead times, and scalability.
• Cost-effectiveness: Competitive pricing without compromising quality.
• Logistical Reliability: Proven track record in timely delivery and supply chain management.

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Global API Suppliers for Clotrimazole and Miconazole

1. Major Manufacturers of Clotrimazole

a) Zhejiang Huarun Pharmaceutical Co., Ltd. (China)

• Overview: Recognized for producing pharmaceutical raw materials with strict GMP protocols.
• Quality Certification: GMP, ISO 9001.
• Regulatory Recognition: Export to US, EU, and Asia; compliant with major pharmacopeia standards.
• Supply Capabilities: Large-scale production with dedicated antifungal API manufacturing lines.

b) Zhejiang Lingkun Pharmaceutical Co., Ltd. (China)

• Overview: Focused on antifungal APIs including Clotrimazole.
• Certifications: GMP, ISO 9001, and CE certification.
• Market Access: Supplying to global generic and branded pharmaceutical firms.

c) Nova Pharmaceuticals (India)

• Overview: Indian pharmaceutical API manufacturer with global footprint.
• Quality Assurance: GMP, ISO 9001, US FDA-approved facilities.
• Specializations: Extensive API portfolio, including Clotrimazole, with multiple regulatory clearances.

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2. Major Manufacturers of Miconazole

a) Sigma-Aldrich / Merck KGaA (Germany/Global)

• Overview: Industry-leading supplier with a comprehensive portfolio of APIs.
• Quality Standards: GMP, ISO, and pharmacopeia-compliant.
• Regulatory Status: Approved for use in pharmaceutical manufacturing globally; high purity standards.

b) Zhejiang Huarun Pharmaceutical Co., Ltd. (China)

• Overview: As above, also produces Miconazole with consistent quality assured manufacturing.
• Certifications: GMP, ISO.

c) Hubei Jumpcan Pharmaceutical Co., Ltd. (China)

• Overview: Focused on antifungal APIs, including Miconazole.
• Certifications: GMP, ISO 9001.
• Strengths: Competitive pricing and reliable supply.

d) Copay Pharmaceutical (India)

• Overview: Supplies Miconazole API to domestic and international markets.
• Quality Certification: GMP, ISO certifications, with several regulatory approvals.

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Regional Insights & Considerations

Asia-Pacific Region

• Advantages: Cost-efficient manufacturing, extensive API production infrastructure, multiple certified suppliers.
• Considerations: Verification of GMP and regulatory compliance is essential; potential delays due to logistical factors.

Europe and North America

• Advantages: Higher regulatory stringency, proven quality standards, well-established supply chains.
• Considerations: Typically higher costs; sourcing from reputable suppliers like Sigma-Aldrich advantageous.

Emerging Markets

• Opportunities: Increasing API production capacity, competitive pricing.
• Risks: Quality assurance, regulatory harmonization, and supply chain stability require careful vetting.

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Regulatory and Quality Assurance

Manufacturers sourcing APIs must verify:

• GMP Compliance: Critical for ensuring batch quality.
• Certificates of Analysis: Must be comprehensive, including impurity profiles.
• Pharmacopoeia Standards: USP, EP, JP, or other relevant standards.
• Regulatory Approvals: FDA Master Files, DMF, or equivalent documentation facilitate registration.

Continual supplier audits and quality audits are recommended to maintain supply chain integrity and compliance.

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Strategic Sourcing Recommendations

• Diversify Suppliers: Mitigate risks associated with geopolitical issues, regulatory changes, or supply disruptions.
• Conduct Due Diligence: Verify supplier certifications, quality controls, and track record.
• Leverage Long-term Relationships: Build partnerships with trusted suppliers for volume assurance and preferential pricing.
• Implement Quality Agreements: Clearly define responsibilities, quality standards, and inspection protocols.
• Monitor Regulatory Changes: Stay updated on evolving pharmacopeial standards and compliance requirements.

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Conclusion

Sourcing high-quality bulk APIs for GYNE-LOTRIMIN 3 Combination Pack involves selecting reputable manufacturers with proven quality standards and regulatory compliance. Major Asian suppliers like Zhejiang Huarun, Zhejiang Lingkun, Jumpcan Pharmaceutical, and Indian manufacturers such as Copay and Nova Pharmaceuticals offer competitive options, whereas established European suppliers like Sigma-Aldrich provide reassurance of stringent quality protocols. A strategic, diversified approach combined with rigorous quality assurance practices ensures continuous supply, regulatory compliance, and optimal product efficacy.

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Key Takeaways

• Reliable API sourcing is foundational for GYNE-LOTRIMIN 3 product integrity.
• Asia-Pacific manufacturers offer cost advantages but require thorough due diligence.
• European and North American suppliers provide high-quality assurance and regulatory certainty.
• Diversity in supplier portfolio mitigates supply chain risks.
• Continuous compliance monitoring and quality audits are essential for maintaining product standards.

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FAQs

1. What are the main quality certifications to verify when sourcing Clotrimazole and Miconazole APIs?
Ensure suppliers possess GMP certification and clearance from pharmacopeias such as USP, EP, or JP. Certificates of Analysis (CoA) and applicable regulatory approvals are also critical.

2. Which regions offer the most cost-effective options for bulk antifungal APIs?
The Asia-Pacific region, especially China and India, generally provides more cost-effective manufacturing options, provided quality controls are verified.

3. How do regulatory standards influence API selection?
APIs conforming to recognized standards reduce regulatory hurdles and facilitate faster registration in target markets, minimizing delays and compliance risks.

4. What factors should influence the choice between multiple suppliers?
Consider quality certifications, supply capacity, cost, reliability, regulatory approvals, and the supplier’s track record in consistent delivery.

5. Is it advisable to engage with suppliers not listed on major pharmacopoeia?
Engaging with non-pharma recognized suppliers involves increased risk; rigorous qualification and verification processes are mandatory to ensure compliance and product safety.

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Sources:

[1] U.S. Pharmacopeia. (2023). USP Monographs: Clotrimazole, Miconazole.
[2] European Pharmacopoeia. (2023). Monographs and standards for antifungal APIs.
[3] Industry reports on global API manufacturing capacities and supplier profiles.
[4] Supplier websites and official documentation.