Bulk Pharmaceutical API Sources for GYNE-LOTRIMIN COMBINATION PACK

Bulk Pharmaceutical API Sources for GYNE-LOTRIMIN COMBINATION PACK

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C6019_SIGMA
Molport		MolPort-002-557-756
Hangzhou APIChem Technology		AC-279

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

Last updated: July 30, 2025

Introduction

The GYNE-LOTRIMIN combination pack, widely used for treating vulvovaginal candidiasis and other fungal infections, combines two active pharmaceutical ingredients (APIs): Clotrimazole and Clioquinol. Ensuring a reliable and high-quality source of these APIs is critical for pharmaceutical manufacturers aiming to produce safe, effective, and compliant combination therapies. This report provides an in-depth overview of the global bulk API sources for both Clotrimazole and Clioquinol, examining supplier landscape, quality considerations, regulatory compliance, and market dynamics essential for procurement and strategic planning.

Clotrimazole: The Primary Antifungal API

Overview

Clotrimazole, an imidazole antifungal agent, is a broad-spectrum drug primarily used to treat yeast infections like vulvovaginal candidiasis. Its API manufacturing process involves complex chemical syntheses, requiring stringent quality controls to meet pharmacopeial standards such as USP, EP, and JP.

Global API Suppliers for Clotrimazole

India

India remains a dominant global supplier of Clotrimazole, with several manufacturing giants recognized for high-quality API production:

• Hetero Labs Limited — A leading producer offering GMP-compliant Clotrimazole APIs, extensively exported worldwide with certifications including USFDA, EU-GMP, and MHRA.

• Aurobindo Pharma — Manufactures high-purity Clotrimazole API, supporting both generic and branded markets with robust quality management systems.

• Zydus Cadila — Known for its vertically integrated API production, Zydus supplies Clotrimazole API adhering to international quality standards.

China

Chinese manufacturers are key global suppliers:

• North China Pharmaceutical Group Corporation (NCPC) — Offers competitively priced Clotrimazole with certifications supporting export markets.

• Hubei Hongyuan Pharmaceutical Co., Ltd. — Produces Clotrimazole API, focusing on quality tailored to regulated markets.

Europe and North America

While less dominant, certain European and North American firms supply high-grade APIs:

• BASF (Germany) — Historically involved in API synthesis, though specific Clotrimazole production is limited; partnerships or licensing may facilitate access.

• Core Pharmaceuticals (India-Europe partnership) — Offers APIs with compliance to stringent global standards.

Quality and Regulatory Considerations

Manufacturers must prioritize APIs meeting USP, EP, or JP standards, with comprehensive documentation including cGMP compliance, stability data, and purity profiles. Suppliers with established regulatory approvals (e.g., FDA, EMA) and successful audits are preferred to minimize regulatory risks.

Market Trends and Pricing

Pricing for Clotrimazole API varies significantly based on purity, batch size, and supplier location. Indian suppliers typically offer competitive rates with lead times of 8–12 weeks, while Chinese sources may provide lower-cost options but require rigorous quality validation.

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Clioquinol: The Antimicrobial and Anti-Inflammatory API

Overview

Clioquinol (also known as iodochlorhydroxyquin) is an organohalogen compound with antiseptic and anti-inflammatory properties. Its use in combination therapies like GYNE-LOTRIMIN is based on its synergistic activity with antifungals, providing broader efficacy against fungal and protozoal infections.

Global API Suppliers for Clioquinol

India

India’s pharmaceutical industry produces Clioquinol APIs primarily for domestic use and export, though on a smaller scale compared to Clotrimazole:

• Cipla Ltd. — Has manufacturing capabilities for Clioquinol, adhering to international quality and regulatory standards.

• Sun Pharmaceutical Industries — Offers Clioquinol APIs supporting global markets with validated manufacturing processes.

Europe and North America

Clioquinol APIs are less commonly produced in developed markets:

• Sigma-Aldrich (Merck KGaA, Germany) — Supplies pharmaceutical-grade Clioquinol for research and specialized pharmaceutical formulations under strict quality controls.

• Toronto-based supplier (Canada) — Certain small-scale biotech companies produce Clioquinol for niche therapeutic applications.

Emerging Suppliers

Due to decreased global demand, suppliers for Clioquinol are limited. However, niche contract manufacturing organizations (CMOs) in India and China can provide custom synthesis services conforming to pharmaceutical standards.

Quality and Regulatory Compliance

Manufacturers should scrutinize suppliers for compliance with ICH Q7 guidelines, stability data, and batch testing reports for impurity profiles. Suppliers with active regulatory approvals (e.g., FDA or EMA filings) significantly reduce market entry hurdles.

Market Dynamics and Challenges

The limited global production of Clioquinol increases dependency on few suppliers, posing supply chain risks. Price premiums may apply due to smaller scale production and regulatory scrutiny over the safety profiles of halogenated quinolines in recent years.

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Synergistic Sourcing Strategy for GYNE-LOTRIMIN API Content

Given the critical nature of both APIs, a strategic sourcing approach should include:

• Supplier Qualification: Prioritize suppliers with proven track records, cGMP compliance, and active regulatory approvals, especially for APIs destined for regulated markets.

• Quality Assurance: Implement rigorous quality audits, stability testing, and validation batches to ensure APIs meet pharmacopeial standards.

• Supply Chain Diversification: Establish relationships with multiple reputable suppliers to mitigate risks associated with geopolitical, manufacturing, or regulatory disruptions.

• Cost Optimization: Balance quality with cost-effectiveness, considering long-term partnerships with reliable suppliers who can offer consistent supply volumes.

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Regulatory & Quality Considerations

The APIs used in GYNE-LOTRIMIN must adhere to international standards:

• GMP Compliance: Ensures consistent product quality, safety, and efficacy.

• Certification Requirements: Certificates of Analysis (CoA), Certificates of Suitability (CEPs), or Drug Master Files (DMFs) facilitate regulatory approval.

• Documentation & Traceability: Critical for global distribution, especially in highly regulated markets like US, EU, and Japan.

Conclusion

Securing high-quality bulk APIs for GYNE-LOTRIMIN combination packs requires meticulous supplier evaluation and adherence to regulatory standards. India remains the dominant source for Clotrimazole, offering reliable and cost-effective options, whereas Clioquinol supply is more constrained, primarily served by niche suppliers. A strategic, diversified sourcing framework aligned with regulatory demands ensures product integrity, supply continuity, and competitive advantage.

Key Takeaways

• Indian manufacturers are leading global suppliers of Clotrimazole API due to cost efficiency and regulatory compliance.

• Clioquinol API production is limited, necessitating ongoing supplier vetting and quality assurance.

• A diversified supplier base reduces supply chain risks and supports compliance with evolving international regulations.

• Prioritize suppliers with active regulatory approvals (FDA, EMA) and robust quality systems to streamline approval processes.

• Implement rigorous quality audits, validation, and documentation to mitigate regulatory and market risks.

FAQs

1. What are the main quality standards to consider when sourcing APIs for GYNE-LOTRIMIN?
   Manufacturers should ensure APIs comply with pharmacopeial standards such as USP, EP, or JP, with certificates verifying purity, stability, and cGMP compliance. Regulatory approvals like FDA or EMA recognition further validate quality.

2. Are there reliable international suppliers for Clioquinol APIs?
   Yes, although limited, some suppliers in India and Europe, including Sigma-Aldrich, provide high-quality Clioquinol APIs for pharmaceutical use, supported by substantial quality documentation.

3. What are the typical lead times for API procurement in this market?
   Lead times generally range from 8 to 12 weeks, depending on supplier location, production capacity, and regulatory validation requirements.

4. How can manufacturers mitigate supply risks for these APIs?
   By diversifying suppliers, establishing long-term agreements, conducting regular audits, and maintaining regulatory compliance documentation, manufacturers can reduce supply disruptions.

5. What factors influence API pricing in this segment?
   Pricing depends on purity levels, scale of production, geopolitical considerations, regulatory compliance costs, and supplier location.

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References

1. [1] International Pharmaceutical API Market Reports, 2022.
2. [2] US FDA API manufacturing guidelines, 2021.
3. [3] European Pharmacopoeia, 2023.
4. [4] Indian Pharmaceutical Industry Overview, IBEF, 2022.
5. [5] Regulatory considerations for APIs, EMA, 2022.