Suppliers and packagers for generic pharmaceutical drug: FLUOCINONIDE

FLUOCINONIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	210554	ANDA	A-S Medication Solutions	50090-6309-0	1 TUBE in 1 CARTON (50090-6309-0) / 30 g in 1 TUBE	2017-10-01
Amneal	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	210554	ANDA	A-S Medication Solutions	50090-7923-0	1 TUBE in 1 CARTON (50090-7923-0) / 15 g in 1 TUBE	2017-10-01
Amneal	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	210554	ANDA	Preferred Pharmaceuticals Inc.	68788-8105-3	1 TUBE in 1 CARTON (68788-8105-3) / 30 g in 1 TUBE	2021-11-03
Amneal	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	210554	ANDA	Amneal Pharmaceuticals NY LLC	69238-1534-2	1 TUBE in 1 CARTON (69238-1534-2) / 120 g in 1 TUBE	2017-10-01
Amneal	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	210554	ANDA	Amneal Pharmaceuticals NY LLC	69238-1534-3	1 TUBE in 1 CARTON (69238-1534-3) / 30 g in 1 TUBE	2017-10-01
Amneal	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	210554	ANDA	Amneal Pharmaceuticals NY LLC	69238-1534-5	1 TUBE in 1 CARTON (69238-1534-5) / 15 g in 1 TUBE	2017-10-01
Amneal	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	210554	ANDA	Amneal Pharmaceuticals NY LLC	69238-1534-6	1 TUBE in 1 CARTON (69238-1534-6) / 60 g in 1 TUBE	2017-10-01

Suppliers for the Pharmaceutical Drug: Fluocinonide

Last updated: February 19, 2026

Who are the leading suppliers of fluocinonide?

Fluocinonide, a potent topical corticosteroid, is manufactured by several pharmaceutical companies. The market comprises both brand-name and generic manufacturers, with products distributed globally. Key suppliers include:

• Pfizer Inc. (brand: Lidex)
• Mylan N.V. (generic formulations)
• Sun Pharmaceutical Industries Ltd.
• Taro Pharmaceuticals Inc.
• Sandoz (a Novartis division)
• Lupin Limited

These companies supply fluocinonide in various formulations, including creams, ointments, gels, and solutions.

Market Segmentation and Product Formulations

Company	Product Name	Formulations Available	Market Regions
Pfizer	Lidex	Cream, ointment	North America, select international markets
Mylan	Generic fluocinonide	Cream, gel	Global
Sun Pharma	Fluocinonide Gel	Gel	India, Southeast Asia
Taro	Taro Fluocinonide	Cream, ointment	US, Canada
Sandoz	Fluocinonide Sandoz	Cream, ointment	Europe, US
Lupin	Lupin Fluocinonide	Cream, gel	India, Middle East, Africa

Distribution Channels

Suppliers distribute fluocinonide through:

• Wholesale distributors: Provide drug wholesalers and clinics.
• Direct sales: To hospitals and healthcare providers.
• Online platforms: For certain generic products, particularly in regions with e-prescription regulations.

Regulatory Approvals and Manufacturing Locations

Major manufacturers operate manufacturing facilities in:

• United States (Pfizer, Taro, Sandoz)
• India (Sun Pharma, Lupin, Lupin)
• Europe (Sandoz)
• Manufacturing compliant with US FDA and EMA standards.

Product approval timelines vary by region, with US FDA approvals dating back to early 2000s for several brands and generics.

Market Trends and Supply Dynamics

• Increasing demand due to topical corticosteroid prescriptions for conditions like psoriasis, dermatitis.
• Growth in generic drug manufacturing, reducing prices and increasing supply.
• Supply chain disruptions occasionally occur due to manufacturing or regulatory delays, affecting availability in some regions.

Key Notes for Stakeholders

• Pfizer's Lidex remains a prominent brand in North America.
• Generics from Mylan, Sun Pharma, Lupin, Taro, and Sandoz dominate global markets.
• Formulation variety supports diverse consumer needs and regional preferences.

References

[1] U.S. Food and Drug Administration. (2022). Drug Applications and Approvals. https://www.fda.gov [2] IQVIA. (2022). Global Pharmaceutical Market Data. https://www.iqvia.com [3] GlobalData. (2021). Top Suppliers of Topical Corticosteroids. https://www.globaldata.com [4] European Medicines Agency. (2022). Marketing Authorisations. https://www.ema.europa.eu