Suppliers and packagers for CANASA

CANASA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	CANASA	mesalamine	SUPPOSITORY;RECTAL	021252	NDA	Allergan, Inc.	58914-501-33	3 SUPPOSITORY in 1 BOX (58914-501-33)	2001-01-05
Abbvie	CANASA	mesalamine	SUPPOSITORY;RECTAL	021252	NDA	Allergan, Inc.	58914-501-42	42 SUPPOSITORY in 1 BOX (58914-501-42)	2001-01-05
Abbvie	CANASA	mesalamine	SUPPOSITORY;RECTAL	021252	NDA	Allergan, Inc.	58914-501-56	30 SUPPOSITORY in 1 BOX (58914-501-56)	2001-01-05

Suppliers for the Pharmaceutical Drug: Canasa

Last updated: July 27, 2025

Introduction

Canasa, the brand name for mesalamine suppositories, is a vital medication primarily used in the management of ulcerative proctitis, a form of inflammatory bowel disease. As an important therapeutic agent, the availability of Canasa hinges on a network of suppliers involved in the manufacturing, distribution, and commercialization processes. This article offers an in-depth exploration of the key suppliers for Canasa, including original manufacturers, generic producers, and distribution channels, providing valuable insights for stakeholders in the pharmaceutical supply chain.

Overview of Canasa and Its Market

Canasa was initially developed and marketed by Salix Pharmaceuticals, a prominent player in gastrointestinal therapeutics. The active pharmaceutical ingredient (API), mesalamine (5-aminosalicylic acid), is an established compound with multiple formulations, including suppositories, oral tablets, and enemas. The market for mesalamine-based products is highly competitive, characterized by several generic manufacturers aiming to offer cost-effective alternatives alongside branded options.

The demand for Canasa is driven by its efficacy and safety profile in treating ulcerative proctitis. As patents expire or are nearing expiration, numerous generic suppliers have entered the market, broadening the supply chain options.

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Key Original and Patent-Holding Manufacturers

Salix Pharmaceuticals (a subsidiary of Bausch Health)

Salix Pharmaceuticals holds the original patent and product rights for Canasa. As the initial manufacturer, Salix designed the proprietary formulation ensuring targeted delivery and sustained release in the rectal cavity. The company's role includes API sourcing, formulation development, manufacturing, and distribution within regulated markets, primarily North America.

Amneal Pharmaceuticals

Amneal, a leading generic manufacturer, produces mesalamine suppositories that are bioequivalent to Canasa. Their products have received approval from regulatory agencies such as the FDA, making them a significant player in the generic supply landscape.

Ferring Pharmaceuticals

Ferring offers mesalamine formulations, including suppositories and enemas, with manufacturing processes aligned with regulatory standards. Their presence in multiple markets enhances the supply capacity for mesalamine-based drugs, including Canasa.

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Global Generic Manufacturers

Several other manufacturers globally produce mesalamine suppositories, often under different brand names but with formulations and delivery mechanisms similar to Canasa. Notable companies include:

• Mylan (now part of Viatris): Produces generic mesalamine suppositories approved in various markets, extending accessible supply chains.

• Apotex: Offers alternative formulations, operating primarily within North America.

• Sgene: A smaller manufacturer supplying mesalamine suppositories in select markets.

Indian and Asian Manufacturers

India and China play prominent roles in generic pharmaceutical manufacturing, including mesalamine suppositories. Key companies include:

• Cipla (India)

• Sun Pharmaceutical Industries (India)

• Shenzhen Yaxin Pharmaceutical (China)

These manufacturers cater largely to markets in Asia, Africa, and Latin America, often supplying through third-party distribution channels or export agreements.

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Distribution and Supply Chain Channels

Distributors and Wholesalers

Pharmaceutical distributors act as intermediaries between manufacturers and healthcare entities. Major distributors such as McKesson, Cardinal Health, and AmerisourceBergen supply mesalamine suppositories, including Canasa, to hospitals, pharmacies, and clinics across North America.

Pharmacy Chains and Retail Networks

Large retail pharmacy chains procure Canasa via distributor networks or direct manufacturer agreements. Their purchasing choices influence the drug's availability, especially in regions with competitive generic markets.

Online Pharmacies and Exporters

Online platforms and international drug exporters expand access, especially in regions where local manufacturing is limited. However, regulatory oversight varies, impacting licensing, quality assurance, and drug authenticity.

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Regulatory Considerations and Supply Dynamics

The supply landscape for Canasa and its generics is shaped significantly by regulatory approvals. Agencies such as the FDA (U.S. Food & Drug Administration), EMA (European Medicines Agency), and local authorities in emerging markets govern manufacturing standards, batch approvals, and market authorizations.

Generic manufacturers submit Abbreviated New Drug Applications (ANDAs) for regulatory approval of their mesalamine suppository products, aiming for bioequivalence with the brand. The approval process directly impacts supply availability and market entry timing.

Supply disruptions can occur due to regulatory non-compliance, manufacturing problems, or raw material shortages, notably in the case of APIs sourced from China or India.

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API Sourcing and Manufacturing

The API, mesalamine, forms the core of supply considerations. Major API suppliers include:

• Ethex Corporation (India): Supplies high-quality mesalamine API to various manufacturers.

• Shandong Sinosen Pharmaceutical (China)

• Mitsubishi Tanabe Pharma (Japan): Produces mesalamine API for specialized formulations.

The API's quality, cost, and availability influence the overall supply chain robustness for Canasa.

Formulation and Packaging

Manufacturers produce suppositories adhering to strict quality standards, ensuring stability, controlled release, and patient safety. Packaging is designed for stability, compliance, and ease of administration, with labeling aligning with regional regulations.

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Emerging Trends Affecting Supply

• Market Competition and Patent Expirations

As patents for mesalamine formulations expire, the proliferation of generics increases supply options, often leading to price reductions and wider market availability.

• Supply Chain Diversification

Manufacturers and distributors are increasingly diversifying sources to mitigate risks associated with geopolitical tensions, raw material shortages, or regulatory hurdles.

• Regulatory Harmonization

Efforts by agencies like the ICH (International Council for Harmonisation) aim to streamline approval processes, impacting how quickly suppliers can bring products to global markets.

• Biologic Alternatives and Innovation

Though not directly related to Canasa, the development of novel therapies impacts market demand and supplier focus, with some manufacturers shifting investments accordingly.

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Conclusion

The supply chain for Canasa involves a complex network of original manufacturers, generic producers, API suppliers, and distribution entities. While Salix Pharmaceuticals remains the pioneer and patent holder, the landscape is populated by numerous generic manufacturers across North America, Europe, and Asia. The global API market, regulatory environment, and market competition influence supply stability and cost.

For healthcare providers and stakeholders, understanding the diverse supply sources is paramount to ensure drug availability, cost management, and quality assurance. The expanding presence of generics and API producers democratizes access but necessitates ongoing vigilance over regulatory compliance and supply chain integrity.

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Key Takeaways

• Salix Pharmaceuticals remains the original patent and initial supplier of Canasa, with multiple generic manufacturers now serving the market.

• Major global API suppliers from India and China supply mesalamine, directly influencing the availability and pricing of suppositories.

• Distribution channels, including large wholesalers and online pharmacies, play critical roles in ensuring widespread accessibility.

• Regulatory approval processes heavily impact supply stability, with patent expirations fostering increased generic competition.

• Diversification of manufacturing sources and API suppliers mitigates risks associated with supply disruptions.

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Frequently Asked Questions (FAQs)

1. Who are the main manufacturers of Canasa currently?
The original manufacturer is Salix Pharmaceuticals. Several generic companies, such as Amneal Pharmaceuticals, Ferring Pharmaceuticals, and global API suppliers from India and China, produce mesalamine suppositories comparable to Canasa.

2. Are there significant differences between branded Canasa and generic equivalents?
Regulatory agencies require generics to be bioequivalent to the branded product, ensuring similar efficacy and safety. Differences may exist in excipients or packaging, but therapeutic equivalence is maintained.

3. How does API sourcing impact Canasa supply?
API quality and availability directly influence production capacity. Most APIs originate from high-volume producers in India and China; disruptions here can lead to shortages.

4. Can Canasa be supplied outside North America?
Yes. While Salix and North American-based generics primarily serve Western markets, Indian and Chinese manufacturers export mesalamine suppositories globally, subject to local regulatory approvals.

5. What risks threaten the supply chain for Canasa?
Regulatory non-compliance, raw material shortages, geopolitical tensions, and manufacturing disruptions can cause supply interruptions. Diversification and regulatory oversight help mitigate these risks.

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Sources
[1] U.S. Food & Drug Administration (FDA). "ANDA Approvals for Mesalamine."
[2] Bausch Health. "Canasa Product Information."
[3] Global Data. "Pharmaceutical API Market Analysis."
[4] IMS Health. "Global Generic Pharmaceutical Market Overview."
[5] European Medicines Agency (EMA). "Regulatory Guidelines for Mesalamine Formulations."