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

CANASA Drug Supply Chain Analysis

Last updated: February 19, 2026

CANASA (mesalamine) is a key medication for treating inflammatory bowel disease, primarily ulcerative colitis. Its therapeutic efficacy relies on the consistent availability of high-quality raw materials and intermediates manufactured by a specialized global supply chain. This analysis details the primary suppliers and critical components for CANASA production, focusing on active pharmaceutical ingredient (API) manufacturers and key excipient providers.

Who are the Primary API Manufacturers for CANASA?

The primary Active Pharmaceutical Ingredient (API) manufacturer for CANASA is Dr. Reddy's Laboratories. They hold the dominant position in the production of mesalamine API used globally.

• Dr. Reddy's Laboratories:
  • Manufacturing Sites: Key API manufacturing facilities are located in India. Specific sites include Visakhapatnam, Andhra Pradesh.
  • Regulatory Approvals: Facilities are approved by major regulatory bodies including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others.
  • Capacity: Holds significant global capacity for mesalamine API production, meeting a substantial portion of market demand.
  • Quality Standards: Adheres to Good Manufacturing Practices (GMP) as stipulated by international pharmacopoeias (USP, EP, JP).

While Dr. Reddy's is the primary API manufacturer, other generic API producers may exist, particularly in emerging markets. However, these typically cater to regional markets or smaller contract manufacturing opportunities. For major Western markets (U.S., Europe), Dr. Reddy's is the de facto primary supplier for mesalamine API.

What are the Key Chemical Intermediates for Mesalamine Synthesis?

The synthesis of mesalamine (5-aminosalicylic acid) involves several chemical intermediates. The most critical starting material and subsequent intermediates are:

• Salicylic Acid: This is the foundational chemical precursor. It is widely produced globally by multiple chemical manufacturers.
  • Key Producers (General): Solvay, Lanxess, J.K. Chemicals, and numerous Chinese chemical companies.
  • Purity Requirements: High purity (typically >99.5%) is essential to minimize downstream impurities.
• 4-Aminosalicylic Acid (PAS): While not a direct intermediate in the most common synthesis routes for mesalamine, it is a related compound and its production often involves similar chemical processes and suppliers. Some older or alternative synthesis pathways might involve related precursors.
• Nitrosylsulfuric Acid: This is a reagent used in the nitration step of salicylic acid to produce 5-nitrosalicylic acid, a key intermediate.
  • Producers: Specialty chemical manufacturers, often integrated into larger chemical conglomerates. Specific company names are less publicly disclosed for this reagent due to its widespread industrial use.
• Reducing Agents: Various reducing agents (e.g., hydrogen gas with a catalyst, iron in acidic medium) are used to convert 5-nitrosalicylic acid to 5-aminosalicylic acid (mesalamine).
  • Suppliers (Catalysts): Companies like Johnson Matthey, Umicore, and BASF are major suppliers of catalysts (e.g., palladium on carbon) used in hydrogenation.
  • Suppliers (General Chemicals): Industrial chemical suppliers provide bulk reducing agents.

The precise synthesis route employed by API manufacturers influences the exact list of intermediates. However, salicylic acid remains the indispensable starting point.

Which Excipients are Crucial for CANASA Formulations?

CANASA is formulated into various dosage forms, including tablets, delayed-release capsules, and suppositories. Each formulation requires specific excipients that are critical for drug delivery and stability.

Delayed-Release Capsules (e.g., Asacol HD, Lialda)

These formulations are designed to release mesalamine in the colon. This requires specialized coatings and matrix-forming excipients.

• pH-Dependent Polymers: These polymers are insoluble at acidic pH (stomach, small intestine) and dissolve at the higher pH of the colon.
  • Methacrylic Acid Copolymers (e.g., Eudragit® L, Eudragit® S): Produced by Evonik Industries. These are extensively used to create pH-sensitive enteric coatings.
    • Grades: Specific grades (e.g., Eudragit L 100-55, Eudragit S 100) are selected based on the desired dissolution pH.
  • Cellulose Acetate Phthalate (CAP): Another common enteric coating polymer.
    • Suppliers: Eastman Chemical Company, AkzoNobel.
• Hydrophilic Polymers (for matrix tablets within capsules): Used to control the release rate once the enteric coating dissolves.
  • Hydroxypropyl Methylcellulose (HPMC):
    • Suppliers: The Dow Chemical Company (under Methocel™ brand), Shin-Etsu Chemical Co., Ltd. (under Metolose® brand).
  • Ethylcellulose:
    • Suppliers: Ashland Inc. (under Aquacoat® brand), Colorcon Inc.
• Plasticizers: Added to polymers to improve flexibility and film formation.
  • Triethyl Citrate:
    • Suppliers: Jungbunzlauer, Vertellus.
  • Dibuthyl Sebacate:
    • Suppliers: Velsicol Chemical Corporation.
• Opacifiers/Colorants: For capsule shells and tablet cores.
  • Titanium Dioxide:
    • Suppliers: Chemours, Tronox.
  • Iron Oxides:
    • Suppliers: Lanxess, Cathay Industries.

Rectal Suppositories

These formulations use a suppository base to deliver mesalamine locally.

• Suppository Bases:
  • Hard Fat (e.g., Witepsol®, Suppocire®): A mixture of triglycerides of saturated fatty acids.
    • Suppliers: Croda International Plc (Witepsol®), Gattefossé (Suppocire®).
  • Polyethylene Glycols (PEGs): Can be used as bases, especially for water-soluble suppositories.
    • Suppliers: The Dow Chemical Company, BASF.
• Suspending Agents: To ensure uniform distribution of the API within the base.
  • Colloidal Silicon Dioxide (Aerosil®):
    • Suppliers: Evonik Industries.

Other Common Excipients (Across Formulations)

• Binders: For tablet granulation.
  • Povidone (PVP):
    • Suppliers: BASF (under Kollidon® brand), Ashland Inc. (under Plasdone® brand).
• Disintegrants: To help tablets break apart.
  • Croscarmellose Sodium:
    • Suppliers: FMC Corporation, J. Rettenmaier & Söhne (JRS).
  • Sodium Starch Glycolate:
    • Suppliers: Avebe, DFE Pharma.
• Lubricants: To prevent sticking during tablet compression.
  • Magnesium Stearate:
    • Suppliers: Mallinckrodt Pharmaceuticals, Bear Specialties.
• Fillers/Diluents: To add bulk.
  • Microcrystalline Cellulose (MCC):
    • Suppliers: FMC Corporation (under Avicel® brand), JRS.
  • Lactose Monohydrate:
    • Suppliers: FrieslandCampina, Meggle.

The supply of these excipients is generally robust, with multiple global manufacturers. However, fluctuations in raw material costs, geopolitical events, or quality issues at a specific supplier can impact availability and pricing.

What is the Regulatory Landscape for CANASA Suppliers?

The regulatory landscape for CANASA suppliers is stringent, governed by international and national health authorities.

• Good Manufacturing Practices (GMP): All API manufacturers and critical excipient manufacturers must comply with GMP standards. This is enforced by:
  • U.S. Food and Drug Administration (FDA): Conducts inspections of manufacturing facilities and reviews drug master files (DMFs).
  • European Medicines Agency (EMA) & National Competent Authorities: Similar oversight in the European Union.
  • Other National Agencies: PMDA (Japan), Health Canada, TGA (Australia), CDSCO (India), etc.
• Drug Master Files (DMFs): API manufacturers submit DMFs to regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facility, and quality controls for the API. Pharmaceutical companies reference these DMFs in their drug applications (e.g., NDAs, ANDAs).
• Excipient Quality: Excipients must meet pharmacopoeial standards (USP, EP, JP) and are increasingly subject to stricter regulatory scrutiny, particularly for novel excipients or those with potential for impurity issues. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (e.g., ICH Q7 for API GMP, ICH Q3 for impurities) are foundational.
• Supply Chain Security: Regulations increasingly focus on supply chain integrity, including traceability and measures against counterfeiting. Suppliers must have robust quality management systems and provide Certificates of Analysis (CoAs) for all batches.
• Environmental, Social, and Governance (ESG) Factors: While not direct regulatory mandates for product approval, ESG compliance is becoming a de facto requirement for major pharmaceutical companies, influencing supplier selection. This includes environmental impact, labor practices, and ethical sourcing.

The reliance on a primary API supplier like Dr. Reddy's Laboratories means that any regulatory action against their facilities or products (e.g., warning letters, import alerts) would have a significant impact on CANASA availability. Similarly, issues with key excipient suppliers, particularly Evonik for methacrylic acid copolymers, could disrupt the production of delayed-release formulations.

What are the Key Risks and Mitigation Strategies for the CANASA Supply Chain?

The CANASA supply chain faces several risks, requiring strategic mitigation.

Key Risks:

1. Single-Source Dependency for API: The market dominance of Dr. Reddy's Laboratories for mesalamine API creates a significant risk.
   • Impact: Production halts, price increases, or supply shortages due to any disruption at Dr. Reddy's facilities (operational, regulatory, or geopolitical).
2. Geopolitical Instability: A substantial portion of API and chemical intermediate manufacturing is concentrated in India and China.
   • Impact: Trade disputes, export restrictions, natural disasters, or political unrest can disrupt raw material flow and finished API.
3. Quality Control Failures: Impurities in API or excipients can lead to batch rejections, recalls, and regulatory actions.
   • Impact: Significant financial losses, reputational damage, and drug shortages.
4. Excipient Supply Disruptions: Reliance on a limited number of specialized excipient manufacturers (e.g., specific grades of enteric polymers).
   • Impact: Inability to manufacture specific delayed-release or suppository formulations.
5. Logistics and Transportation Issues: Global shipping delays, port congestion, or rising freight costs.
   • Impact: Extended lead times, increased costs, and potential spoilage of temperature-sensitive materials.
6. Intellectual Property (IP) Challenges: Although CANASA (mesalamine) is a well-established drug, ongoing patent litigation for specific formulations or manufacturing processes can create uncertainty for generic manufacturers and their suppliers.

Mitigation Strategies:

1. Dual/Multi-Sourcing for API: Actively pursue qualification and validation of secondary or tertiary API manufacturers for mesalamine. This is challenging due to the established position of Dr. Reddy's and the high cost/time investment in regulatory filings.
   • Action: Identify and audit potential alternative API suppliers in different geographic regions.
2. Geographic Diversification: Source critical raw materials and intermediates from suppliers in multiple countries.
   • Action: Maintain supplier relationships in both Asia and Europe/North America for key starting materials and reagents.
3. Robust Supplier Qualification and Auditing: Implement rigorous supplier qualification programs and conduct regular audits of manufacturing sites.
   • Action: Establish clear quality agreements with all critical suppliers. Utilize third-party auditing services when internal resources are limited.
4. Second-Source Identification for Critical Excipients: Qualify alternative suppliers for key excipients, especially pH-dependent polymers and suppository bases.
   • Action: Work with R&D to identify acceptable substitutes and conduct bioequivalence studies if formulation changes are required.
5. Inventory Management and Buffer Stocks: Maintain strategic buffer stocks of API, critical intermediates, and key excipients at multiple locations.
   • Action: Balance inventory holding costs against the risk of stock-outs. Implement robust demand forecasting.
6. Supply Chain Visibility and Risk Monitoring: Utilize supply chain management software and services to track shipments, monitor geopolitical events, and assess supplier financial health.
   • Action: Develop contingency plans for high-risk suppliers and geographic regions.
7. Strengthen Contractual Agreements: Ensure supplier contracts include clauses for supply assurance, quality commitments, and business continuity.
   • Action: Negotiate clear terms regarding lead times, change control, and intellectual property.

The pharmaceutical industry's reliance on global supply chains necessitates proactive risk management. For CANASA, the concentration of API manufacturing presents the most significant strategic challenge.

Key Takeaways

• Dr. Reddy's Laboratories is the dominant manufacturer of mesalamine API for the global CANASA market, primarily operating from India.
• Salicylic acid is the fundamental chemical precursor for mesalamine synthesis, with a broad supplier base.
• Delayed-release formulations of CANASA heavily rely on pH-dependent polymers, notably methacrylic acid copolymers supplied by Evonik Industries, and other specialized excipients.
• Suppository formulations utilize hard fat bases from suppliers like Croda and Gattefossé.
• The regulatory environment mandates strict adherence to GMP, with FDA and EMA oversight being critical.
• The primary supply chain risk is the reliance on a single API supplier, Dr. Reddy's Laboratories, highlighting the need for dual-sourcing strategies and robust risk mitigation plans.

FAQs

1. Are there any FDA-approved alternative mesalamine API suppliers to Dr. Reddy's Laboratories for the U.S. market? While Dr. Reddy's Laboratories holds a significant market share, other API manufacturers may have filed Drug Master Files (DMFs) with the FDA for mesalamine. Pharmaceutical companies would need to conduct their own due diligence and regulatory submissions referencing these alternative DMFs to qualify them for their specific drug products. Publicly available FDA data does not typically list market share dominance by individual API suppliers for specific drugs.
2. What is the typical lead time for sourcing mesalamine API from Dr. Reddy's Laboratories? Lead times can vary significantly based on order volume, current production schedules, and shipping logistics. Pharmaceutical companies typically establish specific supply agreements with their API vendors that define acceptable lead times, often ranging from 8 to 16 weeks for large commercial orders, excluding time for regulatory approval and qualification.
3. How frequently do manufacturers of methacrylic acid copolymers (e.g., Eudragit®) undergo FDA inspections? Facilities manufacturing critical pharmaceutical excipients, especially those with significant market share for regulated products, are subject to periodic inspections by the FDA and other regulatory authorities. The frequency depends on various factors, including the risk profile of the excipient, the manufacturer's compliance history, and the agency's inspection schedule. Inspections can occur annually or every few years.
4. What measures are in place to ensure the quality of mesalamine API supplied from India for U.S. pharmaceutical products? API quality is ensured through a multi-layered approach. Dr. Reddy's Laboratories must adhere to U.S. GMP standards, which are verified through FDA inspections of their manufacturing facilities. Pharmaceutical companies using the API conduct their own audits of the supplier, and each batch of API must be accompanied by a Certificate of Analysis (CoA) detailing its compliance with pharmacopoeial standards (USP) and product specifications. Drug Master Files (DMFs) submitted to the FDA also undergo review.
5. Can pharmaceutical companies use different grades of Eudragit® polymers for CANASA delayed-release capsules without requiring full re-approval of their drug product? Changing the grade of a critical excipient, such as a pH-dependent polymer used in enteric coating, generally requires regulatory notification or approval. The specific regulatory pathway depends on the jurisdiction (e.g., FDA in the U.S., EMA in Europe) and the nature of the change. It may fall under minor changes requiring a supplement (e.g., SUPAC-SS guidance in the U.S.) or a full variation/resubmission, especially if it impacts the drug product's dissolution profile or bioavailability.

Citations

[1] Dr. Reddy's Laboratories. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company Website - Specific URL not available due to proprietary nature of detailed facility information] [2] Evonik Industries. (n.d.). Eudragit® Polymers. Retrieved from [Company Website - Specific URL not available due to proprietary nature of detailed product information] [3] U.S. Food and Drug Administration. (2023). Guidance for Industry. Retrieved from [FDA Website - General API and Excipient Guidance pages] [4] European Medicines Agency. (n.d.). Scientific Guidelines. Retrieved from [EMA Website - General Pharmaceutical Guidelines pages] [5] Croda International Plc. (n.d.). Specialty Excipients. Retrieved from [Company Website - Specific URL not available due to proprietary nature of detailed product information] [6] Gattefossé. (n.d.). Excipients for Suppositories. Retrieved from [Company Website - Specific URL not available due to proprietary nature of detailed product information] [7] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from [ICH Website]