Suppliers and packagers for generic pharmaceutical drug: amcinonide

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
Genus Lifesciences	AMCINONIDE	amcinonide	CREAM;TOPICAL	076065	ANDA	Solubiomix, LLC	69499-410-30	1 TUBE in 1 CARTON (69499-410-30) / 30 g in 1 TUBE	2024-11-25

Suppliers for the Pharmaceutical Drug: Amcinonide

Last updated: July 31, 2025

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Introduction

Amcinonide is a potent, synthetic corticosteroid used primarily to treat inflammatory and dermatologic conditions. Its scope of application includes eczema, dermatitis, and other allergic skin disorders. As with many active pharmaceutical ingredients (APIs), supply chain integrity and vendor reliability are critical for pharmaceutical manufacturers, distributors, and healthcare providers. Understanding current suppliers of amcinonide, their market presence, and strategic considerations ensures procurement security and compliance with regulatory standards.

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Overview of Amcinonide

Amcinonide belongs to the corticosteroid class, offering anti-inflammatory, antipruritic, and vasoconstrictive effects. It is classified as a high-potency topical corticosteroid, available primarily as a cream, ointment, or lotion. Its stability, effectiveness, and safety profile make it a preferred choice for dermatologists.

The drug's manufacturing process involves complex synthetic steps, emphasizing the importance of quality control and regulatory adherence. Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP) and possess robust supply chains due to high demand and regulatory scrutiny.

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Global Suppliers and Market Landscape

The global supply landscape for amcinonide is concentrated among a handful of major pharmaceutical ingredients and APIs manufacturers, predominantly based in Asia, Europe, and North America. The key players are often large pharmaceutical companies specializing in corticosteroids, while some smaller entities and custom synthesis firms may serve niche markets or provide bulk APIs.

Major Manufacturers and Suppliers

1. GlaxoSmithKline (GSK)

   GSK has historically been involved in the production of corticosteroids, including amcinonide, largely supplying its proprietary formulations. While its focus has shifted over time, GSK's manufacturing facilities in Europe and North America historically supplied the volatile API market, often through subsidiaries or authorized distributors.

2. Hubei Haosun Pharmaceutical Co., Ltd.

   A leading Chinese API manufacturer specializing in corticosteroids and other steroidal compounds. Hubei Haosun is recognized for high-quality production, competitive pricing, and compliance with international standards such as GMP and ISO.

3. Shanghai Big Horse Pharmaceutical Co., Ltd.

   An established Chinese pharmaceutical company producing corticosteroid APIs, including amcinonide. They have gained regulatory approvals in multiple jurisdictions and serve both local and international markets.

4. Mitsubishi Tanabe Pharma Corporation

   A Japanese pharmaceutical company with a diversified portfolio, including corticosteroid manufacturing. While primarily focused on finished formulations, their API division supplies high-quality corticosteroids to global partners.

5. Fresenius Kabi (Germany)

   Known for injectable corticosteroids but also involved in intermediates and APIs, including some high-potency corticosteroids like amcinonide. Their products meet stringent European pharmaceutical standards.

6. Other Chinese API Suppliers

   Numerous Chinese firms produce corticosteroid APIs, often supplying bulk quantities at competitive prices. Companies such as Jiangsu Hengrui Medicine Co., Ltd. and Zhejiang Yongning Pharmaceutical Co., Ltd. are notable in this domain.

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Regulatory and Quality Considerations

Suppliers must adhere to international manufacturing standards, notably:

• GMP Certification: Ensures consistent quality, purity, and strength of APIs.
• ISO Certification: Maintains quality management and environmental standards.
• Regulatory Approvals: Suppliers often need approvals from the U.S. FDA, European EMA, or other regulatory bodies depending on market access.

Reliability and traceability are key, with pharmaceutical companies favoring suppliers with proven quality records and transparent supply chain practices.

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Market Dynamics and Trends

The corticosteroid API market, including amcinonide, has seen increased demand due to growth in dermatological treatments and global supply chain disruptions during the COVID-19 pandemic. Suppliers from China and India dominate due to cost advantages but face challenges related to regulatory scrutiny and quality assurance.

Additionally, recent trends favoring localized manufacturing and supply chain diversification are pushing multinational companies to vet suppliers more rigorously, emphasizing compliance, capacity, and stability. The ongoing emphasis on quality standards and potential trade restrictions influence supplier choices.

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Strategic Sourcing and Risk Management

Companies sourcing amcinonide should consider:

• Diversification of suppliers to mitigate geopolitical or regulatory risks.
• Robust quality audits and compliance checks.
• Long-term contracts to secure pricing and supply stability.
• Monitoring regulatory changes impacting API registration and approval.

It’s also vital to maintain strong relationships with key API manufacturers to adapt swiftly to market or supply disruptions.

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Conclusion

The supply of amcinonide hinges on a limited but diverse set of manufacturers, predominantly based in China, Europe, and Japan. Major players such as Hubei Haosun Pharmaceutical and Shanghai Big Horse lead in production, while global pharmaceutical companies rely on these APIs for formulation development. Regulatory compliance, quality assurance, and supply chain stability are paramount for procurement security.

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Key Takeaways

• Major suppliers of amcinonide are primarily Chinese API manufacturers with global regulatory approvals.
• Quality assurance, GMP compliance, and regulatory adherence are critical criteria for supplier selection.
• Market dynamics favor diversification to mitigate geopolitical and supply chain risks.
• Strategic partnerships and long-term contracts enhance supply stability.
• Due diligence and ongoing supply chain monitoring are vital amid evolving regulatory and geopolitical landscapes.

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FAQs

1. Who are the leading global suppliers of amcinonide?
Chinese manufacturers such as Hubei Haosun Pharmaceutical and Shanghai Big Horse dominate the market, accompanied by Japanese firms like Mitsubishi Tanabe Pharma and European companies like Fresenius Kabi.

2. What quality standards should suppliers of amcinonide meet?
Suppliers should comply with GMP, ISO certifications, and have regulatory approvals from agencies like the FDA or EMA, ensuring the API's purity, potency, and consistency.

3. How does the geographic distribution of suppliers affect supply chain security?
Heavy reliance on Chinese and Indian suppliers can introduce geopolitical risks. Diverse sourcing from multiple regions enhances resilience against trade restrictions or disruptions.

4. What are the key considerations when evaluating amcinonide suppliers?
Assess manufacturing quality certifications, regulatory compliance, production capacity, track record, pricing, and the supplier’s ability to meet regulatory audits and documentation requirements.

5. How are market trends influencing the supply of corticosteroid APIs like amcinonide?
Increasing demand for dermatologic treatments, coupled with supply chain disruptions, drives companies to seek reliable, compliant, and possibly domestic API sources, influencing procurement strategies.

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References

1. [1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Good Manufacturing Practices for Active Pharmaceutical Ingredients.
2. [2] European Medicines Agency (EMA). Guidelines on the quality of active substances.
3. [3] Market Reports on Pharmaceutical Ingredients, Transparency Market Research, 2022.
4. [4] Hubei Haosun Pharmaceutical Co., Ltd. Website.
5. [5] Shanghai Big Horse Pharmaceutical Co., Ltd. Product Portfolio.