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Last Updated: March 26, 2026

Suppliers and packagers for FLUOCINONIDE ACETONIDE


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FLUOCINONIDE ACETONIDE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Glenmark Pharms Ltd FLUOCINONIDE ACETONIDE fluocinolone acetonide OIL/DROPS;OTIC 211815 ANDA Glenmark Pharmaceuticals Inc., USA 68462-185-56 1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER 2018-12-18
Glenmark Pharms Ltd FLUOCINONIDE ACETONIDE fluocinolone acetonide OIL;TOPICAL 210539 ANDA Glenmark Pharmaceuticals Inc., USA 68462-590-89 1 BOTTLE in 1 CARTON (68462-590-89) / 118.28 mL in 1 BOTTLE 2018-10-30
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Fluocinonide Acetate

Last updated: February 20, 2026

Who Are the Main Suppliers?

Fluocinonide acetate is a potent topical corticosteroid used for treating inflammatory skin conditions. Its supply chain involves several manufacturers and distributors across global markets.

Major Manufacturers

Company Name Location Details
Taro Pharmaceutical Industries Israel Produces fluocinonide in various formulations, including cream and ointments.
Mylan (Now part of Viatris) United States Supplies fluocinonide as part of dermatology product portfolio.
Sandoz (Novartis division) Switzerland Manufactures topical corticosteroids, including fluocinonide.
Perrigo Company Ireland Distributes fluocinonide for over-the-counter and prescription markets.
Apotex Canada Produces generic versions of fluocinonide topical formulations.

Distributors and Importers

  • McKesson and Cardinal Health (USA): Distribute fluocinonide products from manufacturers to healthcare providers.
  • Shanghai Pacific Pharmaceutical (China): Supplies generic fluocinonide formulations to Asian markets.
  • APEC Pharmaceuticals (South Korea): Provides topical corticosteroids including fluocinonide.
  • Zhejiang Medicine Co. (China): Produces and exports fluocinonide preparations.

Supply Chain Considerations

  • Formulations: Creams, ointments, gels.
  • Regulatory Approvals: Suppliers must meet regional standards, such as FDA approval in the US, EMA in Europe, and CFDA in China.
  • Patent Status: Patents on fluocinonide have expired in many regions, allowing generics to dominate the market.

Market Dynamics

  • The drug's high potency classification increases safety and handling requirements.
  • Generic competition affects pricing and supply availability.
  • Supply chain disruptions are possible due to ingredient shortages or regulatory delays.

Summary

Key suppliers of fluocinonide acetate include Taro, Mylan/Viatris, Sandoz, Perrigo, and Apotex. Distribution extends globally through regional distributors, with market access influenced by regulatory compliance, formulation type, and patent status.


Key Takeaways

  • The main manufacturers are Taro, Mylan, Sandoz, Perrigo, and Apotex.
  • Distributors include McKesson, Cardinal Health, and regional pharmaceutical importers.
  • Market factors such as patent expiration and regulatory standards influence supply dynamics.
  • Generic versions lead to competitive pricing and broader market availability.

FAQs

1. Are there regional differences in suppliers for fluocinonide acetate?
Yes. US and European markets mainly get products from Mylan, Sandoz, and Perrigo. Asian markets often source from local distributors like Shanghai Pacific Pharmaceutical.

2. How does patent expiration affect suppliers?
Patent expiration allows multiple generics to enter the market, increasing supplier options and reducing prices.

3. What formulations are most commonly supplied?
Creams and ointments are the most common formulations, but gels and solutions are also available.

4. What regulations impact the supply chain?
Regulatory approvals, such as FDA, EMA, and CFDA, influence manufacturing standards and market access.

5. Are there risks associated with the supply of fluocinonide acetate?
Yes, supply can be disrupted due to raw ingredient shortages, regulatory issues, or manufacturing delays.


References

  1. U.S. Food and Drug Administration. (2022). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases
  2. European Medicines Agency. (2021). Summary of product characteristics for fluocinonide. https://www.ema.europa.eu/en
  3. Market data reports. (2022). Global topical corticosteroid market analysis. IQVIA.
  4. WHO. (2019). List of essential medicines. World Health Organization.

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