Bulk Pharmaceutical API Sources for FULVICIN P/G

Bulk Pharmaceutical API Sources for FULVICIN P/G

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		G4753_SIGMA
Molport		MolPort-001-739-410
Amadis Chemical		A805480

Bulk Active Pharmaceutical Ingredient (API) Sources for: FULVICIN P/G

Last updated: August 5, 2025

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Introduction

Fulvicin P/G, known generically as griseofulvin, is an antifungal medication primarily prescribed for treating dermatophyte infections. It inhibits fungal cell division by disrupting microtubule function, effectively combating scalp, skin, and nail fungal infections. With the increasing global demand for quality-assured APIs, sourcing reliable bulk suppliers for Fulvicin P/G (griseofulvin) is critical for pharmaceutical manufacturers, wholesalers, and distributors seeking compliance, consistency, and cost efficiency.

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Overview of Fulvicin P/G (Griseofulvin)

Griseofulvin is a natural compound derived originally from Penicillium species, but synthetic manufacturing has become prevalent to meet the extensive demand. The API quality, purity (generally ≥99%), and compliance with pharmacopeial standards (USP, EP, JP) are fundamental to ensuring therapeutic efficacy and safety.

The API market for griseofulvin is characterized by a limited number of specialty suppliers who can meet stringent quality parameters and regulatory standards. These manufacturers often operate internationally, especially in India, China, and Europe, which are prominent global hubs for pharmaceutical API production.

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Key Criteria for Selecting API Suppliers

When sourcing Fulvicin P/G, stakeholders should prioritize the following criteria:

• Regulatory Compliance: Suppliers must possess certifications such as cGMP, ISO, and approvals from regulatory authorities like the FDA, EMA, or local agencies.
• Quality Assurance: Certificates of Analysis (CoA), stability data, and adherence to pharmacopeial standards.
• Production Capacity: Suppliers should accommodate large and small batch requirements with consistent lead times.
• Cost and Logistics: Competitive pricing, reliable shipping, and payment terms.
• Track Record & Reputation: Proven history in API manufacturing, transparency, and customer references.

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Top Global API Suppliers for Griseofulvin (Fulvicin P/G)

1. Hansol Pharm, South Korea

Hansol Pharm is a recognized European and Asian supplier specializing in antifungal APIs, including griseofulvin. Their APIs conform to USP and EP standards, with rigorous quality control systems. Their manufacturing facilities are cGMP-certified, ensuring high-quality produce suitable for pharmaceutical use. They supply globally, including to North America, Europe, and Asia.

2. Zhejiang Xianju Pharmaceutical, China

This manufacturer is a key player in China's API market, producing griseofulvin that complies with international pharmacopeia. Their production is certified with ISO 9001 and cGMP standards, offering competitive pricing and reliable supply chains. They have established a global distribution network catering to both generic and branded formulations.

3. Huangshan Sunhere Pharmaceutical, China

Sunhere Pharmaceutical is actively involved in the synthesis and supply of antifungal APIs like griseofulvin. Their compliance with GMP regulations and quality certifications make them a trusted source for bulk API procurement, especially for Asian markets. Their capacity for large batch production allows for scalability.

4. Pharmaochem, India

Pharmaochem is among India’s leading API manufacturers with a diversified product portfolio. Their griseofulvin API complies with all major international standards, and their facilities are cGMP-certified. The company emphasizes stringent quality control and offers consistent product quality suitable for global markets.

5. Aurobindo Pharma, India

Aurobindo Pharma supplies a broad range of APIs, including antifungals like griseofulvin. Their manufacturing plants are approved by multiple regulatory agencies, and they typically provide competitive prices and reliable supply logistics to multinational pharmaceutical companies.

6. Marksans Pharma, India

Marksans Pharma offers high-purity griseofulvin API, backed by extensive quality testing and certifications. Their scalable production capacity and global client base make them an attractive sourcing option for pharmaceutical companies seeking certified APIs.

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Emerging Trends and Considerations

• Regulatory Trends: Increased scrutiny from authorities compels suppliers to maintain high compliance standards. Suppliers with strong regulatory track records are preferred.
• Supply Chain Resilience: Diversified sourcing and inventory management are essential to mitigate risks posed by geopolitical or logistic disruptions.
• Quality Mindset: Suppliers offering full transparency with CoA, stability data, and batch-specific documentation facilitate risk management and regulatory audits.
• Price Optimization: While cost remains a factor, quality and compliance are paramount, especially considering the generic nature of antifungal APIs.

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Conclusion

Securing a reliable source of Fulvicin P/G (griseofulvin) API demands thorough due diligence. The top suppliers—mainly from India, China, and South Korea—offer diverse options balancing cost, quality, and regulatory compliance. Stakeholders should align their sourcing strategy with their quality standards and supply chain requirements, emphasizing validation, certifications, and proven track records.

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Key Takeaways

• The global market for griseofulvin APIs is concentrated among Indian, Chinese, and Korean manufacturers with strict compliance standards.
• Quality certifications such as cGMP, ISO, and pharmacopeial adherence are non-negotiable for safe and effective pharmaceutical production.
• Diversification of suppliers mitigates geopolitical and logistical risks, ensuring continuity of supply.
• Conducting independent audits and relying on trusted third-party verifications enhance supplier reliability.
• Price is competitive but secondary to quality; regulatory compliance and manufacturing standards are essential.

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FAQs

1. What are the main regulatory considerations when sourcing griseofulvin APIs?
Sourcing entities must ensure APIs comply with pharmacopeial standards (USP, EP), possess cGMP certification, and have regulatory approvals for their manufacturing facilities from authorities like the FDA or EMA.

2. How do I verify the quality of bulk griseofulvin API?
Request detailed Certificates of Analysis (CoA), batch-specific stability data, and third-party audit reports. Conducting independent third-party testing further confirms API purity and stability.

3. Are there specific geographic regions with better API quality for Fulvicin P/G?
India, China, and South Korea dominate API manufacturing with high compliance standards, but due diligence is essential regardless of geographic origin, as quality varies among suppliers.

4. What are the typical lead times for API sourcing for griseofulvin?
Lead times vary based on supplier location, order quantity, and regulatory clearance but generally range from 4 to 12 weeks. Advanced planning and inventory management ensure supply continuity.

5. How can I mitigate supply chain risks in API procurement?
Diversify suppliers, establish long-term contracts, maintain buffer stock, and develop relationships with reliable logistics partners to minimize interruptions.

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References

[1] U.S. Pharmacopeia, Griseofulvin Monograph.
[2] European Pharmacopoeia, Griseofulvin Monograph.
[3] MarketsandMarkets, API Market Overview.
[4] Company websites and certifcate publications for Hansol Pharm, Zhejiang Xianju Pharmaceutical, Huangshan Sunhere Pharmaceutical, Pharmaochem, Aurobindo Pharma, and Marksans Pharma.