Suppliers and packagers for CICLOPIROX

CICLOPIROX

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	CICLOPIROX	ciclopirox	CREAM;TOPICAL	078463	ANDA	Cosette Pharmaceuticals, Inc.	0713-0638-15	1 TUBE in 1 BOX (0713-0638-15) / 15 g in 1 TUBE	2007-05-22
Cosette	CICLOPIROX	ciclopirox	CREAM;TOPICAL	078463	ANDA	Cosette Pharmaceuticals, Inc.	0713-0638-18	1 TUBE in 1 BOX (0713-0638-18) / 90 g in 1 TUBE	2007-05-22
Cosette	CICLOPIROX	ciclopirox	CREAM;TOPICAL	078463	ANDA	Cosette Pharmaceuticals, Inc.	0713-0638-31	1 TUBE in 1 BOX (0713-0638-31) / 30 g in 1 TUBE	2007-05-22
Glenmark Pharms	CICLOPIROX	ciclopirox	CREAM;TOPICAL	090273	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-297-17	15 g in 1 CARTON (68462-297-17)	2009-11-13

Suppliers for the Pharmaceutical Drug: Ciclopirox

Last updated: July 27, 2025

Introduction

Ciclopirox is a synthetic broad-spectrum antifungal agent used primarily in topical formulations to treat various fungal and dermatophyte infections. Its efficacy in combating dermatophyte, yeast, and mold infections has made it a staple in antifungal therapy, especially in dermatological and cosmetic applications. Understanding the global landscape of ciclopirox suppliers is essential for healthcare providers, pharmaceutical companies, and investors seeking to ensure quality, supply chain security, and cost-effectiveness.

Overview of Ciclopirox

Ciclopirox was first introduced in the 1980s and has since been incorporated into numerous dermatological products, including creams, lotions, and shampoos. Its mechanism involves chelating polyvalent cations, which inhibits fungal enzyme activity, disrupting cell membrane function and leading to fungal cell death. It is marketed under various trade names, such as Loprox, Penlac, and Mycostat, among others.

Global Suppliers and Manufacturers

Several pharmaceutical manufacturers produce ciclopirox, with key players operating across different regions. The supply chain involves raw material suppliers, active pharmaceutical ingredient (API) producers, and finished product manufacturers.

Major API Suppliers

• BASF SE (Germany): One of the leading chemical companies involved in the production of ciclopirox API. BASF supplies pharmaceutical-grade APIs globally, adhering to stringent quality standards compliant with Good Manufacturing Practices (GMP).

• Jiangsu Nhwa Pharmaceutical Co., Ltd. (China): An established Chinese manufacturer that produces ciclopirox API. The company has gained recognition for its competitive pricing and compliance with international quality standards.

• Hangzhou Huaan Pharmaceutical Co., Ltd. (China): A notable supplier of ciclopirox API, serving both domestic and export markets, with GMP certification and scalable production capacity.

• Sandoz (Novartis): Engaged in the distribution of pharmacies and partnering with various API producers, Sandoz sources ciclopirox from multiple API suppliers for their topical formulations.

• Taj Pharmaceuticals Limited (India): An API manufacturer with a focus on antifungal agents, including ciclopirox, catering to Indian and international markets.

Finished Dosage Form Manufacturers

• Mayne Pharma (Australia): Produces topical ciclopirox formulations under various brands, sourcing APIs from approved suppliers.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Manufactures antifungal creams and shampoos containing ciclopirox, with integrated supply chain management.

• Eczacibasi Monrol (Turkey): Produces specialized dermatological products with ciclopirox, sourcing APIs from multiple suppliers.

Private Label and Contract Manufacturing

Many pharmaceutical companies and skincare brands partner with contract manufacturing organizations (CMOs) to produce ciclopirox-based products, often sourcing raw materials from the aforementioned API suppliers to ensure cost-effectiveness and compliance.

Supply Chain Considerations

The strategic sourcing of ciclopirox involves evaluating API quality, regulatory compliance, cost, and manufacturing capacity. The Chinese API producers, such as Jiangsu Nhwa and Hangzhou Huaan, dominate the supply with extensive production facilities and competitive pricing, but may face regulatory scrutiny regarding quality certifications. European manufacturers like BASF provide high-quality APIs but at a premium price point.

Regulatory Landscape and Certifications

Suppliers must comply with international standards, including ISO certifications, GMP certifications, and pharmacopoeia monographs (USP, EP, BP). These certifications ensure purity, potency, and safety. For example, BASF and Jiangsu Nhwa both possess GMP certification, facilitating global distribution.

Market Dynamics and Trends

Global demand for ciclopirox remains stable, driven by dermatological indications such as tinea infections, seborrheic dermatitis, and onychomycosis. The rising prevalence of fungal infections, especially in urban and tropical regions, sustains demand. Suppliers are investing in capacity expansion and quality upgrades to meet international standards.

Competitive Landscape

The competitive environment is characterized by price-sensitive buyers and regulatory oversight. Major players like BASF benefit from established reputation and quality assurance, whereas Chinese suppliers often offer cost advantages. This facilitates a dual supply chain model, balancing quality and price competitiveness.

Conclusion

The ciclopirox supply chain is diverse, with key API suppliers located in Europe, China, and India. The choice of supplier hinges on quality assurance, regulatory compliance, pricing, and supply reliability. As demand continues, suppliers must adapt to regulatory changes and quality expectations globally.

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Key Takeaways

• Major API Suppliers: BASF (Germany), Jiangsu Nhwa and Hangzhou Huaan (China), Taj Pharmaceuticals (India).
• Procurement Considerations: Prioritize suppliers with GMP and pharmacopoeia certifications to ensure product safety and compliance.
• Cost vs. Quality: Chinese API producers offer competitive prices but require rigorous quality verification; European suppliers provide high assurance with higher costs.
• Regulatory Landscape: Ongoing compliance with international standards is critical for market access, especially for export-oriented manufacturers.
• Market Outlook: Steady global demand driven by dermatology indications necessitates scalability and continuous quality improvements from suppliers.

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FAQs

1. Who are the leading global producers of ciclopirox API?
The foremost producers include BASF SE (Germany), Jiangsu Nhwa Pharmaceutical (China), and Hangzhou Huaan Pharmaceutical (China). These entities supply high-quality APIs aligned with international standards.

2. What factors should healthcare providers consider when sourcing ciclopirox?
Providers should evaluate API quality, regulatory approvals, supplier certifications (GMP), cost, and supply reliability to ensure consistent product efficacy and safety.

3. How does the geographic origin of ciclopirox influence its quality and regulatory compliance?
European suppliers like BASF are often perceived as highly compliant, adhering to stricter regulations, whereas Chinese and Indian suppliers may offer cost advantages but require thorough quality assessments to meet international standards.

4. Are there alternative suppliers emerging in the ciclopirox market?
Yes, with growing demand, several emerging manufacturers in Southeast Asia and Eastern Europe are entering the market, expanding supply options and fostering competitive pricing.

5. What are the key regulatory certifications to verify from ciclopirox suppliers?
Suppliers should possess GMP certification, ISO certifications, and pharmacopoeia compliance (USP, EP, BP), ensuring their APIs meet pharmaceutical quality standards.

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Sources:
[1] Pharmaceutical Manufacturing Journal, "Global Api Market Overview," 2022.
[2] BASF Official Website, "Active Pharmaceutical Ingredients," accessed 2023.
[3] Jiangsu Nhwa Pharmaceutical Co., Ltd., Company Profile & GMP Certification.
[4] European Medicines Agency, "Regulatory Guidelines for APIs," 2022.
[5] Market Research Reports, "Global Antifungal Market Outlook," 2023.