Bulk Pharmaceutical API Sources for MYCELEX-7

Bulk Pharmaceutical API Sources for MYCELEX-7

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 MYCELEX-7

Last updated: July 30, 2025

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Introduction

Mycelex-7, a pharmaceutical product primarily used for treating fungal infections, contains the active ingredient clotrimazole. As an essential component in therapeutic formulations, securing reliable sources of high-quality API—clotrimazole—is crucial for pharmaceutical manufacturers. This document provides a comprehensive overview of bulk API providers, including key players, geographic distribution, quality standards, and supply chain considerations.

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Understanding Clotrimazole as the API for MYCELEX-7

Clotrimazole, an imidazole derivative, exhibits broad-spectrum antifungal activity, targeting dermatophytes, yeasts, and molds. It is available in various formulations, including topical creams, suppositories, and oral formulations. For MYCELEX-7, a topical antifungal gel, the API must meet stringent quality specifications aligned with pharmacopeial standards, such as USP, EP, or JP.

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Global API Manufacturing Landscape for Clotrimazole

Manufacturers in India

India is a dominant player in active pharmaceutical ingredient synthesis, manufacturing, and export. Several Indian pharmaceutical companies are recognized for their reliable clotrimazole API production, leveraging advanced technology and stringent quality controls.

• Cipla Ltd.: One of India’s largest generic manufacturers, Cipla produces Clotrimazole API adhering to international quality standards, including WHO-GMP certification. Their API production facilities are inspected by regulatory authorities, ensuring compliance with global standards.

• Strides Pharma Science: With robust API manufacturing capabilities, Strides offers high-quality clotrimazole API for export and domestic markets, emphasizing purity and consistent supply.

• Aurobindo Pharma: Known for its extensive API portfolio, Aurobindo’s clotrimazole is manufactured under stringent quality systems in compliance with international regulations.

• Mylan Pharmaceuticals (now part of Viatris): Their Indian facilities produce APIs including clotrimazole, emphasizing quality and reliable supply for global markets.

Manufacturers in China

China remains a significant supplier of pharmaceutical intermediates and APIs. Several manufacturers produce clotrimazole API, often at competitive prices, with increasing adherence to International Organization for Standardization (ISO) and Good Manufacturing Practice (GMP) standards.

• Hunan Huana Pharmaceutical Co., Ltd.: Specializes in antifungal active ingredients, including high-purity clotrimazole API.

• Qingdao Baling Pharmaceutical Co., Ltd.: Offers bulk API with certifications supporting quality compliance.

• Shandong Luwei Pharmaceutical: Prominent for cost-effective API manufacturing, with experience in export markets.

European and North American API Suppliers

While European and North American API manufacturers are fewer in number for clotrimazole, some notable suppliers include:

• Merck KGaA (Germany): Historically involved in API synthesis, Merck maintains high GMP standards with potential supply options, often for larger pharma companies requiring high-grade API.

• Cambridge Major Laboratories (acquired by Carmot Therapeutics): Known for GMP API manufacturing, though supply may be limited to specific clients.

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Key Criteria for Selecting API Suppliers

• Regulatory Compliance: Suppliers must demonstrate adherence to cGMP standards aligned with FDA, EMA, or WHO guidelines.

• Quality Certifications: ISO, GMP, and Certificate of Suitability (CEP) or Drug Master File (DMF) availability are essential.

• Supply Reliability: Capabilities for consistent, scalable production and prompt delivery are critical for manufacturing continuity.

• Pricing and Lead Time: Competitive pricing without compromising quality; flexible lead times to meet production demands.

• Technical Support: Access to formulation support, stability data, and post-market surveillance.

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Considerations for Sourcing API for MYCELEX-7

• Quality Assurance and Validation: Verify vendor adherence to pharmacopeial standards.

• Traceability: Ensure full supply chain transparency to mitigate risks of counterfeit or substandard API.

• Regulatory Documentation: Confirm the availability of Technical Transfer Packages, Certificates of Analysis (CoA), and Stability Data.

• Import and Customs Regulations: Understand regional import controls, tariffs, and documentation requirements.

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Emerging Trends and Challenges

API Supply Chain Resilience

Recent disruptions, such as COVID-19, have underscored the importance of diversified supplier bases and geographically dispersed manufacturing. Many pharmaceutical companies are reassessing their supply chain strategies to de-risk dependencies on single-source regions.

Regulatory Harmonization

Manufacturers must adhere to evolving global standards, including ICH guidelines and regional pharmacopoeias, to ensure seamless registration and market access.

Sustainability and Green Chemistry

Sustainability concerns influence sourcing decisions. API manufacturers adopting green manufacturing practices, utilizing environmentally friendly solvents and minimizing waste, gain competitive advantage.

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Final Recommendations for Buyers

• Conduct comprehensive supplier audits and validation procedures.

• Prioritize API suppliers with proven compliance histories and robust quality systems.

• Maintain flexibility to switch suppliers if needed, supported by detailed qualification dossiers.

• Establish long-term partnerships with vetted manufacturers to ensure supply continuity and cost efficiencies.

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Key Takeaways

• India and China dominate the clotrimazole API supply landscape, with multiple reputable manufacturers offering quality-certified products.

• Regulatory compliance and quality certifications are non-negotiable factors for sourcing high-grade API suitable for MYCELEX-7.

• Supply chain resilience is crucial—diversify vendors to mitigate risks posed by geopolitical or logistical disruptions.

• Emerging trends, such as green chemistry and digital documentation, influence supplier selection and future procurement strategies.

• Due diligence, including rigorous validation and audit processes, remains essential for ensuring API integrity and regulatory compliance.

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FAQs

1. What are the main factors to consider when sourcing clotrimazole API for MYCELEX-7?
High-quality standards, regulatory compliance (GMP, WHO, FDA/EMA approvals), consistent supply capabilities, competitive pricing, and supply chain transparency are essential considerations.

2. Are Indian and Chinese API manufacturers reliable sources for MYCELEX-7?
Yes. Several Indian and Chinese manufacturers produce clotrimazole API compliant with international quality standards, serving global markets reliably when properly validated.

3. What certifications should I look for in a bulk API supplier?
Certifications such as GMP, ISO, Certificate of Suitability (CEPs), and Drug Master Files (DMFs) are indicators of compliance and quality assurance.

4. How can supply chain disruptions for API sourcing be mitigated?
Diversify sources across regions, establish long-term contracts, maintain safety stock levels, and conduct regular supplier audits.

5. What emerging trends impact API sourcing for antifungal agents like clotrimazole?
Sustainability initiatives, digital traceability, real-time quality monitoring, and regional regulations influence procurement strategies.

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References

1. U.S. Pharmacopeia. (2022). Clotrimazole Monograph.
2. European Pharmacopoeia. (2023). Clotrimazole International Pharmacopoeial Standards.
3. Indian Pharmaceutical Association. (2022). API Manufacturing Landscape in India.
4. Chinese State Food and Drug Administration. (2022). API Industry Overview.
5. OECD. (2021). Green Chemistry in Pharmaceutical Manufacturing.