Bulk Pharmaceutical API Sources for FULVICIN P/G 330

Bulk Pharmaceutical API Sources for FULVICIN P/G 330

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		G4753_SIGMA
Molport		MolPort-001-739-410
Amadis Chemical		A805480
Enamine		EN300-52615
TCI (Tokyo Chemical Industry)		G0384

Bulk Active Pharmaceutical Ingredient (API) Sources for: FULVICIN P/G 330

Last updated: August 10, 2025

Introduction

Fulvicin P/G 330, the pharmaceutical-grade formulation of griseofulvin, is an antifungal agent used primarily for treating dermatophytic infections. As a critical component of antifungal therapy, the procurement and supply chain of Griseofulvin API are vital for pharmaceutical companies to produce effective medications. This article provides an in-depth review of bulk API sources for Fulvicin P/G 330, emphasizing global manufacturing trends, supplier qualifications, regulatory considerations, and supply chain stability.

Overview of Griseofulvin as an API

Griseofulvin is a polyketide fungal metabolite initially isolated from Penicillium species. It exhibits antifungal activity by disrupting microtubule formation in fungal cells, inhibiting mitosis. Its solubility profile and pharmacokinetics necessitate specific formulation considerations, but the core API's quality and purity are paramount. The global demand for griseofulvin remains steady, driven by dermatophytic fungal infection treatments.

Global API Manufacturing Landscape

Leading Countries in API Production

The bulk API production for griseofulvin is primarily concentrated in regions with established pharmaceutical manufacturing bases, notably:

• India: India's API sector is renowned for its cost-effective, high-quality manufacturing capabilities. Major Indian API producers, such as Hetero Labs, Glenmark, and Lupin, are registered suppliers of griseofulvin API. Their manufacturing sites comply with stringent cGMP standards, and they often supply to multinational pharmaceutical firms.

• China: Chinese API producers are significant contributors to the global supply chain for various APIs, including griseofulvin. Companies like Hengkang Pharma and Qingdao KingFool Pharmatech have established facilities that meet international quality standards.

• European Union and North America: While production is less prevalent in these regions, certain specialty manufacturers and licensed API suppliers export high-purity griseofulvin to the global market. Companies such as Mundipharma and Bristol-Myers Squibb hold API manufacturing licenses and supply globally.

API Supplier Qualification and Accreditation

Suppliers of griseofulvin API must demonstrate compliance with regulatory standards such as ICH Q7 (Good Manufacturing Practice for APIs) and audit-ready facilities. Quality certifications like ISO 9001 and ISO 13485 (for pharmaceutical quality management) are commonly required. Additionally, suppliers must provide detailed analytical data, stability profiles, and batch consistency reports.

Key Attributes for API Suppliers of Fulvicin P/G 330

• Regulatory Compliance: Suppliers need to adhere to cGMP, with inspected manufacturing sites by agencies such as the FDA, EMA, or WHO.

• Quality Assurance: Strict quality control, including high-performance liquid chromatography (HPLC) purity levels (>99%), residual solvent analysis, and microbiological testing.

• Supply Capabilities: Ability to deliver bulk quantities reliably, scalable manufacturing capacity, and backup supply arrangements.

• Traceability and Documentation: Complete batch documentation, Certificate of Analysis (CoA), and compliance certificates for each lot.

Major API Suppliers for Griseofulvin

Supplier Name	Location	Certification	Key Strengths	Contact & Website
Hetero Labs Ltd.	India	cGMP, ISO 9001	Large production capacity, consistent quality	www.hetero.com
Gujarat Terce Laboratories	India	cGMP	Competitive pricing, proven quality	www.gtlindia.com
Qingdao KingFool Pharmatech	China	cGMP, ISO	Advanced manufacturing, ample supply	www.kingfoolpharma.com
Mundipharma	Germany	GMP certified	High purity standards, reliable supply	www.mundipharma.com
Jilin Fuhuan Pharmaceutical Co.	China	GMP	Cost-effective solutions	www.jilinfuhuan.com

Note: Engagements with these suppliers should include comprehensive technical audits and validation processes.

Regulatory and Quality Considerations

Pharmaceutical companies sourcing griseofulvin API must prioritize suppliers with a robust compliance history. Validation of API batches through analytical testing, including assays for purity and residual solvents, remains essential. Suppliers should also furnish stability data aligning with the intended formulation and storage conditions. Participation in quality agreements and audits ensures ongoing compliance and supply chain transparency.

Supply Chain Challenges and Mitigation Strategies

• Geopolitical Risks: Trade restrictions or tariffs could impact API supply. Establishing multiple sourcing channels mitigates disruption risks.

• Regulatory Changes: Updates in Good Manufacturing Practices or drug regulations necessitate periodic supplier audits and recertification.

• Supply Chain Transparency: Maintaining traceability from raw material to finished API reinforces quality control and regulatory compliance.

• Demand Fluctuations: Contracts with flexible volume terms and inventory management policies support responsiveness to market fluctuations.

Emerging Trends

• Synthetic and Biotechnological Advancements: Novel synthetic routes and biotechnological approaches are being explored to optimize griseofulvin production, potentially reducing costs and environmental impact.

• Sustainability Initiatives: Suppliers adopting greener manufacturing practices and renewable raw material sourcing align with global sustainability goals.

• Digital Supply Chain Integration: Utilizing blockchain and IoT enhances traceability and real-time supply chain monitoring.

Conclusion

Securing a reliable supply of high-quality griseofulvin API is fundamental for pharmaceutical manufacturers producing Fulvicin P/G 330. Indian and Chinese manufacturers dominate global supply chains, with European and North American suppliers focusing on high purity and regulatory compliance. Engaging with verified suppliers, ensuring compliance with international standards, and implementing risk mitigation strategies are critical for uninterrupted production. Strategic sourcing aligned with regulatory demands enhances supply stability and product integrity.

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Key Takeaways

• India and China are the primary global sources for griseofulvin API, with key players holding robust cGMP certifications.
• Rigorous supplier qualification, including audits and analytical validation, are non-negotiable for quality assurance.
• Diversification of supply sources reduces geopolitical and market risks, ensuring steady API availability.
• Regulatory compliance and documentation are essential to meet international pharmaceutical standards.
• Emerging technologies and sustainability efforts are shaping the future landscape of API manufacturing.

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FAQs

Q1: How do I verify the quality of griseofulvin API from new suppliers?
A: Conduct comprehensive audits, review Certificates of Analysis (CoA), perform laboratory testing (purity, residual solvents, microbial limits), and verify regulatory compliance through site inspections and certifications.

Q2: Are there specific regulatory approvals required for importing griseofulvin API?
A: Yes. Importers must ensure suppliers are compliant with local and international regulations, and overall, APIs must meet the quality standards specified by agencies like the FDA, EMA, or WHO, with proper documentation supporting batch approval.

Q3: What are the typical lead times for bulk API procurement?
A: Lead times can range from 4 to 12 weeks, depending on supplier capacity, batch size, and regulatory clearance processes. Early engagement and supply chain planning are recommended.

Q4: How can I mitigate supply chain disruptions for griseofulvin API?
A: Establish relationships with multiple verified suppliers, maintain safety stock, incorporate flexible purchase agreements, and closely monitor geopolitical developments and regulatory changes.

Q5: What are advancements in griseofulvin production technology?
A: Emerging methods include optimized synthetic routes, biotechnological fermentation processes, and greener manufacturing practices aimed at reducing environmental impact and production costs.

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References:

[1] U.S. Food & Drug Administration (FDA). Guidance for Industry: API Quality.
[2] International Council for Harmonisation (ICH). Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[3] Market reports on pharmaceutical API manufacturing, 2022.
[4] Company websites and public filings for verified API suppliers.