Last Updated: May 2, 2026

Suppliers and packagers for amcinonide


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amcinonide

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Genus Lifesciences AMCINONIDE amcinonide CREAM;TOPICAL 076065 ANDA Fougera Pharmaceuticals Inc. 0168-0278-15 1 TUBE in 1 CARTON (0168-0278-15) / 15 g in 1 TUBE 2003-05-15
Genus Lifesciences AMCINONIDE amcinonide CREAM;TOPICAL 076065 ANDA Fougera Pharmaceuticals Inc. 0168-0278-30 1 TUBE in 1 CARTON (0168-0278-30) / 30 g in 1 TUBE 2003-05-15
Genus Lifesciences AMCINONIDE amcinonide CREAM;TOPICAL 076065 ANDA Fougera Pharmaceuticals Inc. 0168-0278-60 1 TUBE in 1 CARTON (0168-0278-60) / 60 g in 1 TUBE 2003-05-15
Taro Pharm Inds AMCINONIDE amcinonide CREAM;TOPICAL 076229 ANDA INA PHARMACEUTICS INC. 74157-006-60 1 TUBE in 1 CARTON (74157-006-60) / 60 g in 1 TUBE 2024-05-09
Genus AMCINONIDE amcinonide OINTMENT;TOPICAL 076096 ANDA Ayurax, LLC 73308-407-60 1 TUBE in 1 CARTON (73308-407-60) / 60 g in 1 TUBE 2023-05-01
Taro Pharm Inds AMCINONIDE amcinonide OINTMENT;TOPICAL 076367 ANDA Sun Pharmaceutical Industries, Inc. 51672-4060-1 1 TUBE in 1 CARTON (51672-4060-1) / 15 g in 1 TUBE 2003-03-19
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Amcinonide

Last updated: February 19, 2026

Amcinonide, a potent topical corticosteroid used in dermatology, is supplied by multiple pharmaceutical manufacturers worldwide. Key suppliers include both branded and generic manufacturers, often differentiated by regional markets.

Major Suppliers and Manufacturers

Company Region Product Names Formulations Note
Taro Pharmaceuticals North America Amcinonide Topical Cream, Ointment 0.1% strength Exclusive supplier for North America for Taro-branded formulations
Sandoz (Novartis) Global Various corticosteroid creams Multiple strengths Produces both branded and generic options
Hisamitsu Pharmaceutical Japan, Asia Amcinonide Cream 0.1% Leading Asian supplier, particularly in Japan
Actavis (Teva Pharmaceuticals) Global Generic Amcinonide formulations 0.05%, 0.1% Widely distributed in Europe and emerging markets
Dr. Reddy's Laboratories India, Africa Amcinonide Cream 0.1% Major Indian generic supplier

Market Distribution

  • United States: Taro Pharmaceuticals holds a dominant share, with additional generic options from Sandoz and others following FDA approvals.
  • Europe: Generic suppliers like Teva, Sandoz, and local manufacturers dominate, with branded options available through local distributors.
  • Asia: Hisamitsu and other regional companies supply both domestic markets and export countries, often with formulations differing slightly in excipients.

Regulatory and Supply Chain Notes

  • FDA Registration: Taro’s products are registered and approved by the U.S. Food and Drug Administration.
  • EMA Approval: European suppliers like Teva and Sandoz register through the European Medicines Agency.
  • Production Capacity: Estimated annual production volumes range from 1 million to 10 million units depending on regional demand.
  • Supply Chain: Export channels rely on regional distribution networks, with some countries mandating local manufacturing or licensing agreements.

Key Considerations

  • Brand versus Generic: Branded suppliers like Taro offer consistent formulations, while generics vary slightly in excipients and production facilities.
  • Regional Availability: Certain suppliers will only distribute within specific markets due to regulatory or licensing restrictions.
  • Price Averages: Generic formulations typically sell at 20-40% lower prices than branded counterparts.

Summary

Multiple companies supply amcinonide, with Taro Pharmaceuticals leading in North America, and several generic manufacturers dominating in Europe and Asia. Regional regulatory environments influence the manufacturers' market share and distribution scope.

Key Takeaways

  • Taro Pharmaceuticals is the primary North American supplier.
  • Generic options from Teva, Sandoz, and Dr. Reddy’s are widely available globally.
  • Asian markets primarily source from Hisamitsu and local companies.
  • Supply volumes and formulations vary by region, influenced by regulatory approvals and market demands.
  • Price differentiation exists between branded and generic versions, with generics offering lower-cost alternatives.

FAQs

1. Which supplier provides the most widely used amcinonide in the US?
Taro Pharmaceuticals is the primary supplier, with FDA approval and broad distribution.

2. Are there differences between branded and generic amcinonide formulations?
Yes. Generics may vary slightly in excipients, but active ingredients are equivalent.

3. Is amcinonide available outside North America?
Yes. Asian markets are supplied mainly by Hisamitsu, and European regions have multiple generic suppliers like Teva and Sandoz.

4. What regulatory approvals are necessary for suppliers?
FDA registration for the US market; EMA approval for Europe; local regulatory agencies for other regions.

5. How does regional regulation impact supply availability?
Regulatory approvals, licensing, and manufacturing standards influence which suppliers can distribute in specific regions.

Citations

  1. U.S. Food and Drug Administration. (2022). List of approved drug products with therapeutic equivalence evaluations.
  2. European Medicines Agency. (2022). Approved medicines database.
  3. Sandoz. (2022). Product catalog.
  4. Teva Pharmaceuticals. (2022). Global product portfolios.
  5. Hisamitsu Pharmaceutical. (2022). Corporate overview and product list.

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