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Last Updated: December 12, 2025

Suppliers and packagers for ALA-CORT


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ALA-CORT

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Crown Labs ALA-CORT hydrocortisone CREAM;TOPICAL 080706 ANDA Crown Laboratories 0316-0126-01 1 TUBE in 1 CARTON (0316-0126-01) / 28.4 g in 1 TUBE 1973-03-09
Crown Labs ALA-CORT hydrocortisone CREAM;TOPICAL 080706 ANDA Crown Laboratories 0316-0126-03 1 TUBE in 1 CARTON (0316-0126-03) / 85.2 g in 1 TUBE 1973-03-09
Crown Labs ALA-CORT hydrocortisone CREAM;TOPICAL 080706 ANDA Crown Laboratories 0316-0128-16 454 g in 1 JAR (0316-0128-16) 2016-01-06
Crown Labs ALA-CORT hydrocortisone CREAM;TOPICAL 080706 ANDA Crown Laboratories 0316-0128-20 1 TUBE in 1 CARTON (0316-0128-20) / 20 g in 1 TUBE 2016-01-06
Crown Labs ALA-CORT hydrocortisone CREAM;TOPICAL 080706 ANDA Crown Laboratories 0316-0128-30 1 TUBE in 1 CARTON (0316-0128-30) / 30 g in 1 TUBE 2016-01-06
Crown Labs ALA-CORT hydrocortisone CREAM;TOPICAL 080706 ANDA Crown Laboratories 0316-0186-01 1 TUBE in 1 CARTON (0316-0186-01) / 28.4 g in 1 TUBE 1973-03-09
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Ala-Cort

Last updated: August 2, 2025

Introduction

Ala-Cort, a corticosteroid medication primarily used for its anti-inflammatory and immunosuppressant properties, remains a vital component in managing various dermatological, rheumatological, and respiratory conditions. As healthcare markets evolve, understanding the suppliers and manufacturing landscape for Ala-Cort is essential for pharmaceutical professionals, distributors, and healthcare providers seeking reliable sourcing options. This report provides a comprehensive overview of the key suppliers for Ala-Cort, their geographic distribution, manufacturing capacities, and strategic considerations for procurement.


Market Overview and Demand Drivers

Ala-Cort, often identified by its generic or proprietary names, contains active corticosteroid compounds, such as alclometasone dipropionate, and may be formulated in various delivery systems (e.g., creams, ointments, or injectable forms). The global demand hinges on the prevalence of conditions treatable by corticosteroids, regulatory approvals, and pharmaceutical distribution channels.

The increasing incidence of autoimmune diseases, dermatological disorders, and respiratory conditions globally sustains the demand for Ala-Cort formulations. Additionally, the stringent regulatory landscape emphasizes manufacturing quality, especially for corticosteroids, which are often subject to controlled distribution due to their potent medicinal effects.


Major Suppliers and Manufacturing Countries

1. Leading Multinational Pharmaceutical Companies

Many large pharmaceutical firms are involved in the production and distribution of corticosteroids, including Ala-Cort. These companies often develop proprietary formulations, sometimes under patent protections, and possess extensive global manufacturing and distribution networks:

  • Novartis: A global leader with a diversified portfolio, including corticosteroid formulations. Their manufacturing facilities worldwide ensure robust supply chains for corticosteroidal drugs, including Ala-Cort variants.

  • Pfizer Inc.: Engaged in steroid production, with a focus on quality assurance and broad global reach. Pfizer's manufacturing units in the United States and Europe manufacture corticosteroid formulations for international markets.

  • GlaxoSmithKline (GSK): Offers various topical corticosteroids, including alclometasone-based products, through their extensive pharmaceutical manufacturing network. GSK's presence in Asia and Europe makes them strategic suppliers for regional markets.

  • Sanofi: Produces corticosteroids as part of its dermatological and respiratory product lines. Sanofi's global manufacturing footprint supports a steady supply of Ala-Cort medications, especially within European and Latin American markets.

2. Regional and Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies rely on regional CMOs for the production of corticosteroids, including Ala-Cort:

  • Hikma Pharmaceuticals: A key player in the generics segment, with manufacturing plants in the Middle East, Europe, and the United States, capable of producing corticosteroid formulations at scale.

  • Sandoz (Novartis division): Specializes in generics and biosimilars, offering corticosteroid products in various forms. Their manufacturing hubs are strategically positioned across Europe, India, and the US.

  • Dr. Reddy's Laboratories: Based in India, they supply corticosteroid products globally, including formulations akin to Ala-Cort, leveraging their robust API synthesis and formulation capacity.

  • Mylan (now part of Viatris): Produces corticosteroid medications and contracts manufacturing for generic versions of Ala-Cort in regions like Asia, Europe, and North America.

3. API Suppliers

Active Pharmaceutical Ingredient (API) sourcing is crucial for formulation manufacturers. Major API suppliers of corticosteroids include:

  • Xinhua Pharmaceutical (China): A dominant API producer supplying corticosteroid raw materials for global manufacturing.

  • Hikal Ltd. (India): Offers API synthesis for corticosteroids, serving multiple pharmaceutical companies worldwide.

  • Cipla (India): Supplies corticosteroid APIs to domestic and international formulators.

  • Sinopharm (China): Provides corticosteroid raw materials vital for manufacturing Ala-Cort formulations.


Regional Distribution and Market Dynamics

Asia-Pacific: Dominates in API production and generic corticosteroid formulations, with India and China as primary manufacturing hubs. Competitive pricing and large-scale capacity make this region a significant supplier base.

Europe and North America: Characterized by high regulatory standards and advanced manufacturing facilities, these regions supply both branded and generic Ala-Cort products, with companies like GSK and Pfizer leading.

Latin America and Africa: Growing markets with increasing access to corticosteroids, often supplied through regional distributors and CMOs, with sourcing increasingly reliant on Asian API suppliers.


Strategic Considerations for Sourcing

  • Quality Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP) and regulatory standards such as FDA, EMA, and WHO approvals.

  • Supply Chain Reliability: Due to the critical nature of corticosteroids, procurement strategies should prioritize suppliers with proven manufacturing consistency and contingency plans.

  • Pricing and Contract Flexibility: Pricing varies significantly across regions and supplier scale. Strategic negotiations and long-term agreements often secure better terms.

  • Regulatory and Patent Status: For proprietary Ala-Cort formulations, licensing and patent considerations influence supplier options; generics rely heavily on API availability from Chinese and Indian manufacturers.


Future Outlook

The pharmaceutical supply landscape for Ala-Cort is expected to remain stable, driven by global demand and expanding markets. The increasing shift toward generic formulations offers opportunities for regional and contract manufacturers to expand their offerings, provided they meet quality standards. Additionally, geopolitical factors, trade policies, and regulatory reforms will influence sourcing strategies moving forward.


Key Takeaways

  • Major multinational firms like Novartis, Pfizer, GSK, and Sanofi are primary sources for branded Ala-Cort formulations, supported by extensive global manufacturing footprints.

  • Regional API suppliers in China and India predominantly provide corticosteroid raw materials, enabling a robust generics market.

  • Contract manufacturing organizations (CMOs) such as Hikma and Sandoz serve as vital partners for formulation production, especially in regions with high demand.

  • Ensuring compliance with GMP and regulatory standards is paramount to securing supply reliability and product quality.

  • Manufacturers and buyers must consider geopolitical shifts, currency fluctuations, and evolving regulatory landscapes to sustain a resilient supply chain.


FAQs

1. Who are the leading global suppliers of Ala-Cort?
Major global suppliers include multinational companies such as Novartis, Pfizer, GSK, and Sanofi, with additional contributions from regional CMOs and API manufacturers primarily based in China and India.

2. What regions are dominant in Ala-Cort manufacturing and supply?
Asia-Pacific, particularly India and China, dominate API and generic formulation manufacturing; Europe and North America supply branded and high-standard generic products with advanced regulatory compliance.

3. How do regulatory standards impact Ala-Cort suppliers?
Compliance with GMP, FDA, EMA, and WHO standards ensures high-quality production and regulatory approval, directly influencing supplier credibility and market access.

4. What are key considerations when sourcing Ala-Cort?
Focus on quality standards, supply chain reliability, cost competitiveness, and legal considerations related to patents and licensing.

5. Is the Ala-Cort market expected to grow?
Yes, driven by increasing demand for corticosteroids in various treatment areas and expanded access in emerging markets, the Ala-Cort market is poised for steady growth, especially in generics.


References

[1] Statista. "Global Pharmaceutical Market Overview." 2022.
[2] WHO. "Guidelines for the Quality of Pharmacotherapeutic Products." 2021.
[3] IMS Health. "Global Trends in Corticosteroid Usage." 2022.
[4] Company Websites and Annual Reports: Novartis, Pfizer, GSK, Sanofi, Hikma, Sandoz.
[5] United States Food and Drug Administration (FDA). "Approved Corticosteroid Drugs." 2022.

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