Suppliers and packagers for ANUSOL HC

ANUSOL HC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Salix Pharms	ANUSOL HC	hydrocortisone	CREAM;TOPICAL	088250	ANDA	Salix Pharmaceuticals, Inc	65649-401-30	1 TUBE in 1 CARTON (65649-401-30) / 30 g in 1 TUBE	1984-06-06

Suppliers for the Pharmaceutical Drug: ANUSOL HC

Last updated: August 5, 2025

Introduction

ANUSOL HC stands as a trusted pharmaceutical product widely prescribed for the relief of hemorrhoids and associated anal conditions. Its active ingredients typically include hydrocortisone acetate, a corticosteroid that reduces inflammation, and a local anesthetic like pramocaine, which alleviates pain and itching. Given its therapeutic importance, understanding the supply landscape of ANUSOL HC—its authorized suppliers, manufacturing pathways, and distribution channels—is critical for healthcare providers, pharmacists, and risk management professionals.

Overview of ANUSOL HC

Manufactured by various pharmaceutical companies worldwide, ANUSOL HC falls under the category of topical hemorrhoid treatments. In many jurisdictions, it is a proprietary formulation, sometimes marketed under different brand names with equivalent formulations. The drug's composition generally includes:

• Hydrocortisone acetate (1%): a corticosteroid for anti-inflammatory effects.
• Pramocaine (2%): an anesthetic for pain relief.
• Additional components: such as emollients, preservatives, and carriers that facilitate topical application.

Authorized Manufacturers and Suppliers

The supply of ANUSOL HC is primarily controlled by licensed pharmaceutical companies that have obtained regulatory approval from relevant authorities. These include:

1. GlaxoSmithKline (GSK)

GSK is a leading manufacturer of ANUSOL HC, especially prevalent in North American and European markets. The company has extensive manufacturing facilities in the UK, Canada, and the US, producing consistent, regulatory-compliant formulations for both prescription and over-the-counter use.

2. Perrigo Company

Perrigo manufactures and distributes over-the-counter hemorrhoid remedies, including formulations akin to ANUSOL HC, in multiple markets—particularly in the United States, under private labels or generic equivalents.

3. Teva Pharmaceutical Industries Ltd.

Teva supplies generic versions of hydrocortisone-based hemorrhoid creams, which are considered bioequivalent to ANUSOL HC and are often available through wholesale distributors as authorized generics.

4. Mylan (now part of Viatris)

Mylan has historically produced generic corticosteroid topical creams similar to ANUSOL HC, with distribution channels spanning global markets, especially in regions where patent protections are relaxed or have expired.

5. Local and Regional Manufacturers

In various countries, local pharmaceutical firms or regional generics manufacturers produce formulations equivalent to ANUSOL HC, often under different brand names but complying with local regulatory standards. These suppliers typically utilize imported active pharmaceutical ingredients (APIs) or contract manufacturing services.

Regulatory Landscape and Supply Chain Dynamics

Regulatory approval determines the authorized suppliers for ANUSOL HC in any jurisdiction. The drug's approval process involves agencies such as:

• U.S. Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• Health Canada
• Medicines and Healthcare products Regulatory Agency (MHRA, UK)
• Local health authorities in Asia, Africa, and South America

Manufacturers must adhere to Good Manufacturing Practices (GMP) to maintain their license and supply credentials.

Supply Chain Considerations

• Active Pharmaceutical Ingredient (API) sourcing: Manufacturer reliance on reliable API suppliers, often located in India, China, or Europe.
• Manufacturing sites: Plants certified by regulatory agencies ensure product quality and compliance.
• Distribution channels: Wholesalers, pharmacy chains, hospital supply systems, and direct-to-consumer outlets serve as primary distribution pathways.
• Generic and branded variations: Competition among generic manufacturers influences pricing and supply continuity.

Market Dynamics and Key Suppliers

The supply landscape is characterized by intense competition, patent expirations, and regulatory changes. Some key players include:

• GSK and its authorized distributors: As original patent holders or proprietary formulators, they dominate in certain regions.
• Generic manufacturers (e.g., Teva, Mylan): Provide bioequivalent products at lower costs, expanding consumer access.
• Regional producers: Fill gaps in less regulated markets, often complying with local GMP standards.

Challenges in Supply

Supply disruptions can occur due to:

• Regulatory non-compliance
• API shortages (especially from major API producers in India/China)
• Manufacturing plant audits or recalls
• Geopolitical issues affecting trade

Emerging Trends and Future Outlook

The global trend toward biosimilars and generics will likely increase the number of suppliers producing ANUSOL HC or its equivalents. Additionally, stricter regulatory scrutiny may consolidate supply chains, favoring those with robust GMP compliance. Digital supply chain management and strategic API sourcing are poised to enhance product availability.

Conclusion

ANUSOL HC’s supply chain comprises established multinational pharmaceutical companies, regional generic manufacturers, and local producers adhering to stringent regulatory standards. Major suppliers include GSK, Perrigo, Teva, and Mylan, along with regional companies that produce approved bioequivalent formulations. The sustainability of supply depends largely on regulatory compliance, API availability, and geopolitical stability.

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Key Takeaways

• Leading suppliers of ANUSOL HC are GSK, Perrigo, Teva, and Mylan, each operating within regulatory frameworks globally.
• The supply chain relies heavily on quality GMP-certified manufacturing, API sourcing, and efficient distribution channels.
• Market competition and patent expirations continue to diversify the supplier landscape, increasing access but also posing supply chain risks.
• Regulatory oversight and API availability are pivotal to maintaining consistent supplies of ANUSOL HC.
• Emerging trends point to increased generic penetration and supply chain resilience strategies.

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FAQs

1. Are there authorized generic alternatives to ANUSOL HC?
Yes, generic formulations containing hydrocortisone acetate and pramocaine are available from multiple manufacturers, such as Teva and Mylan, approved by regulatory agencies for bioequivalence.

2. How can healthcare providers ensure supply continuity for ANUSOL HC?
By engaging with authorized distributors, maintaining relationships with multiple approved suppliers, and monitoring regulatory updates and API supply statuses.

3. Are regional manufacturers of ANUSOL HC compliant with international GMP standards?
Many regional suppliers adhere to GMP accreditation specific to their markets. It's essential to verify certification and compliance from regulatory authorities.

4. What are the primary risks related to the supply of ANUSOL HC?
API shortages, manufacturing quality issues, regulatory non-compliance, and geopolitical factors impacting trade routes.

5. How does patent protection affect the supply of ANUSOL HC?
Patent expiry enables generic manufacturers to produce bioequivalent formulations, increasing supply options and potentially reducing costs but requiring regulatory approval and GMP compliance.

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References

[1] GlaxoSmithKline Product Information. (2022).
[2] Perrigo Company Official Website. (2022).
[3] Teva Pharmaceuticals – Product Portfolio. (2022).
[4] Mylan (Viatris) Product Approvals. (2022).
[5] Global API Market Analysis. (2021).