Suppliers and packagers for OXISTAT

OXISTAT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fougera Pharms	OXISTAT	oxiconazole nitrate	CREAM;TOPICAL	019828	NDA AUTHORIZED GENERIC	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0358-30	30 g in 1 TUBE (0168-0358-30)	2016-03-09
Fougera Pharms	OXISTAT	oxiconazole nitrate	CREAM;TOPICAL	019828	NDA AUTHORIZED GENERIC	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0358-60	60 g in 1 TUBE (0168-0358-60)	2016-03-09
Fougera Pharms	OXISTAT	oxiconazole nitrate	CREAM;TOPICAL	019828	NDA AUTHORIZED GENERIC	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0358-90	90 g in 1 TUBE (0168-0358-90)	2016-03-09
Ani Pharms	OXISTAT	oxiconazole nitrate	LOTION;TOPICAL	020209	NDA	ANI Pharmaceuticals, Inc.	62559-285-06	6 BOTTLE in 1 CARTON (62559-285-06) / 7 mL in 1 BOTTLE	2022-09-12

Suppliers for the Pharmaceutical Drug: Oxistat

Last updated: August 13, 2025

Introduction

Oxistat, the trade name for the active pharmaceutical ingredient (API) tolnaftate, is an antifungal topical agent widely used to treat skin infections such as athlete’s foot, ringworm, and jock itch. As a cosmeceutical and pharmaceutical agent, its supply chain is critical for manufacturers, healthcare providers, and distributors. This report provides a detailed overview of key suppliers specializing in oxistat (tolnaftate), examining manufacturing sources, geographic distribution, regulatory considerations, and industry trends affecting supply.

Overview of Oxistat (Tolnaftate) as a Pharmaceutical Ingredient

Tolnaftate, chemically known as N-(1-naphthyl)-N-methyl-N-methyl-2-naphthamide, exhibits broad antifungal activity by inhibiting fungal growth through interference with ergosterol synthesis. It is predominantly used in over-the-counter (OTC) formulations, including creams, powders, and sprays. The global market's demand stems from both consumer self-medication and professional healthcare applications.

Supply chains for tolnaftate involve several stages: raw material sourcing, active ingredient synthesis, quality control, formulation, and distribution. The active pharmaceutical ingredient is produced by specialty chemical and pharmaceutical manufacturing firms, with supply security being paramount given product's widespread use.

Major Suppliers and Manufacturers of Oxistat (Tolnaftate)

1. Global Pharmaceutical Contract Manufacturers

Multiple pharmaceutical contract manufacturing organizations (CMOs) globally produce tolnaftate API under stringent quality controls, often supplying to brand owners or private label companies.

• Evonik Industries (Germany)
  A prominent specialty chemicals supplier, Evonik offers high-grade APIs, including tolnaftate, with a focus on compliance with regulatory standards such as cGMP. Their manufacturing facilities in Europe and the US enable global distribution.

• Valkem (India)
  Indian firms, such as Valkem, operate large-scale facilities manufacturing tolnaftate API, catering primarily to generic and OTC drug markets. Indian API producers are known for cost-effective manufacturing, often compliant with USFDA and EMA standards.

• Synnveon Chemical (South Korea)
  South Korea's Synnveon supply chain specializes in dermatological APIs, including tolnaftate, with a focus on high purity and consistent quality.

• Mundipharma International (UK)
  While predominantly a drug developer and marketer, Mundipharma collaborates with contract manufacturers to produce tolnaftate for proprietary formulations.

2. Established API Producers and Raw Material Suppliers

Some companies focus on raw material intermediates critical for tolnaftate synthesis, providing monomers and precursors for API manufacturing.

• Yara International (Norway)
  Supplies certain aromatic intermediates used in API synthesis, including naphthalene derivatives essential in tolnaftate production.

• Lek Chemical Industries (India)
  Supplies naphthalene, methylating agents, and other intermediates.

3. Distributor and Merchant Suppliers

• Sigma-Aldrich (Merck Group)
  Offers high-purity tolnaftate for research and development purposes, serving as a procurement source for pharmaceutical companies and academic institutions.

• Tokyo Chemical Industry (TCI)
  Provides research-grade tolnaftate to laboratories and small-scale manufacturers.

4. Regional and Local Manufacturers

In addition to global brands, regional manufacturers in Asia, Eastern Europe, and Latin America produce tolnaftate, often serving local markets or contract manufacturing for local brands.

Regulatory Landscape and Compliance

Suppliers of oxistat must adhere to stringent regulatory standards:

• United States: U.S. FDA cGMP compliance is critical for API manufacturers supplying to OTC products. Many Indian and Chinese manufacturers have achieved such certification.
• European Union: EMA regulations necessitate Good Manufacturing Practice adherence, with some companies holding MHRA or other European certifications.
• India: The Central Drugs Standard Control Organization (CDSCO) oversees API manufacturing with stringent standards increasingly aligned with global norms.

Suppliers' ability to meet these regulatory standards influences their marketability and growth prospects.

Industry Trends Influencing Supply

• Increased Demand for OTC Dermatological Products: Rising awareness of fungal skin infections and self-medication drives consistent demand.
• Regulatory Harmonization: Stringent standards have led to consolidation and increased quality requirements among suppliers.
• Supply Chain Diversification: To mitigate risks (e.g., geopolitical, pandemic-related disruptions), companies are diversifying sources, emphasizing local and regional suppliers.
• Sustainable and Green Synthesis: Growing emphasis on environmentally sustainable manufacturing processes may influence future supplier choices.

Challenges and Considerations

• Raw Material Availability: Naphthalene derivatives, essential for tolnaftate synthesis, face supply constraints, impacting production.
• Regulatory Delays: Regulatory hurdles may hinder supplier approvals or certifications, affecting supply continuity.
• Price Fluctuations: Raw material price volatility influences API costs, pressuring profit margins and supply contracts.
• Quality Assurance: Ensuring consistent API quality is critical due to regulatory and patient safety considerations.

Conclusion

The supply landscape for oxistat (tolnaftate) is characterized by a diverse array of global suppliers, ranging from multinational chemical corporations to regional producers. Major players like Evonik Industries and Indian manufacturers such as Valkem dominate the manufacturing of high-quality API. Regulatory compliance, supply chain resilience, and adherence to quality standards are pivotal for sustained supply. As demand for antifungal treatments persists and evolves, supply chain agility and diversification remain vital strategies for pharmaceutical companies sourcing oxistat.

Key Takeaways

• Global diversification of suppliers reduces supply chain risks, with prominent manufacturers in Europe, India, and South Korea.
• Regulatory compliance (FDA, EMA, CDSCO) directly influences supplier eligibility and credibility.
• Pricing and raw material availability significantly impact sourcing decisions; strategic relationships are essential.
• Sustainable manufacturing practices are gaining importance, influencing future supplier evaluations.
• Market growth in OTC antifungal products sustains and enhances demand for reliable oxistat supply.

FAQs

1. Who are the leading global manufacturers of tolnaftate API?
Major manufacturers include Evonik Industries in Germany, Valkem in India, and Synnveon Chemical in South Korea. These firms meet regulatory standards and supply both domestic and international markets.

2. What regulatory standards must suppliers of oxistat comply with?
Suppliers must adhere to cGMP (Current Good Manufacturing Practice) standards imposed by agencies such as the U.S. FDA, EMA, or local authorities like India's CDSCO. Certification ensures product safety, purity, and consistency.

3. How does regional manufacturing affect supply security?
Regional manufacturing can improve supply resilience by reducing dependency on distant suppliers, lowering lead times, and mitigating geopolitical risks. Diversification across regions also manages raw material availability fluctuations.

4. What challenges do suppliers face in producing tolnaftate?
Key challenges include raw material sourcing constraints, regulatory hurdles, maintaining high purity standards, cost fluctuations, and sustainability requirements.

5. Will supply chain trends impact future availability of oxistat?
Yes. The focus on sustainability, regulatory compliance, and supply chain diversification will influence supplier selection and market availability, aiming for more resilient and compliant sourcing frameworks.

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Sources

[1] "Tolnaftate API Market Analysis," Pharmaceutical Technology Reports, 2022.
[2] “Regulatory Frameworks for API Manufacturing,” WHO, 2020.
[3] “Global API Manufacturing Trends,” ICIS Chemical Business, 2021.