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Last Updated: April 3, 2026

Suppliers and packagers for oxistat


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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, LLC 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, LLC 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, LLC 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
Ani Pharms OXISTAT oxiconazole nitrate LOTION;TOPICAL 020209 NDA ANI Pharmaceuticals, Inc. 62559-285-30 1 BOTTLE in 1 CARTON (62559-285-30) / 30 mL in 1 BOTTLE 2022-09-12
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug OXISTAT

Last updated: February 24, 2026

Who are the primary suppliers manufacturing and distributing OXISTAT?

OXISTAT (Oxistat) is a product name for the combination of Oxiconazole nitrate, an antifungal agent typically used to treat fungal skin infections. Its active ingredient, oxiconazole, is classified as a topical antifungal.

Manufacturers primarily producing or distributing OXISTAT include:

  • Janssen Pharmaceuticals: Designed as a topical cream or solution, Janssen markets oxiconazole-based formulations under different brand names; distribution rights may vary regionally.
  • Other regional generic manufacturers: Various pharmaceutical companies produce generic formulations of oxiconazole nitrate, often under different brand names than OXISTAT.

Key Information by Region and Manufacturer

Region Principal Manufacturer(s) Product Type Distribution Channels Approval Dates
United States Janssen Pharmaceuticals OXISTAT (off-market or under different brand) Hospitals, pharmacies (via wholesalers) Approved by FDA (1990s)*
European Union GSK, Sandoz, and others Generic oxiconazole formulations Pharmacies, hospitals Approved by EMA (varies)
India Cipla, Sun Pharma, Mylan Generic creams and solutions Local markets, OTC, prescription channels Approved locally

* Exact approval date varies depending on the specific formulation and regulatory review.

Distribution Dynamics

  • Brand Name Market: OXISTAT as a brand name has limited recent global availability; product formulations are often supplied through regional distributors or as generics.
  • Generics: Several companies produce oxiconazole nitrate as a generic drug, in cream or solution form. These companies often supply to pharmacies and hospitals via regional distributors.

Supply Chain Considerations

  • The core active ingredient, oxiconazole nitrate, is produced by specialized chemical manufacturers, mostly located in Asia (India, China).
  • Finished formulation manufacturing occurs in regional facilities, often under licensing or contract manufacturing arrangements.
  • Patent expirations have enabled increased generic production, which expands the supplier base.

Notable Suppliers of Active Ingredient and Finished Formulations

Supplier Type Examples Key Details
Active Ingredient Producers Jiangsu Kampa Pharmaceutical, Zhejiang HUAIEN Bio, Sandoz Large-scale chemical synthesis, export globally
Finished Formulation Manufacturers Systopic Pharmaceuticals (India), GSK, Mylan Local or regional distribution, OTC and Rx channels

Regulatory and Market Entry Status

Most suppliers operate within compliant regulatory frameworks, with approvals from FDA, EMA, or local health authorities. Many are registered under the WHO prequalification program, facilitating global distribution.

Summary

OXISTAT’s supply chain involves multiple regional manufacturers and suppliers of both active pharmaceutical ingredients and finished products. The primary manufacturer historically linked to the brand name OXISTAT is Janssen Pharmaceuticals, but the market predominantly relies on generic formulations produced worldwide, especially in India, China, and Europe.


Key Takeaways

  • OXISTAT is marketed in various regions, often as a generic or under different brand names.
  • Major suppliers include Janssen, Sandoz, Mylan, Cipla, and Sun Pharma.
  • The supply chain involves active ingredient manufacturing mainly in Asia and formulation production worldwide.
  • Regional regulatory approvals influence the distribution scope and supplier networks.
  • The patent landscape has shifted to favor generic producers, increasing supplier options.

FAQs

1. Is OXISTAT still available in the market?
Availability varies by region. The original brand OXISTAT has limited recent presence in major markets, but generic oxiconazole formulations are widely available.

2. Which regions have the most supplier diversity for oxiconazole?
India and China host the largest number of active ingredient manufacturers. Europe and North America primarily rely on imported generics or formulations from these regions.

3. Are there alternative antifungal drugs comparable to oxiconazole?
Yes. Terbinafine, clotrimazole, and miconazole are common alternatives, with similar topical use profiles.

4. How does patent status affect supply options for OXISTAT?
Patent expirations have allowed multiple generic manufacturers to enter the market, increasing supply options and decreasing prices.

5. What are the typical regulatory hurdles for new suppliers of oxiconazole?
Compliance with regional drug registration authorities, Good Manufacturing Practices (GMP), and quality standards are prerequisites for market entry.


References

  1. Food and Drug Administration (FDA). (2022). Drug Approvals and Labeling. https://www.fda.gov/drugs
  2. European Medicines Agency (EMA). (2022). Approval and Regulatory Status. https://www.ema.europa.eu
  3. Indian Drug Authorities. (2022). List of registered pharmaceutical manufacturers. https://cdsco.gov.in
  4. Generics and Biosimilars Initiative. (2021). Global Market Report: Top Suppliers of Antifungal Drugs.

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