Suppliers and packagers for ACCOLATE

ACCOLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547	NDA	AvKARE	42291-970-60	60 TABLET, COATED in 1 BOTTLE (42291-970-60)	2023-04-05
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547	NDA	AvKARE	42291-971-60	60 TABLET, COATED in 1 BOTTLE (42291-971-60)	2023-04-05
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547	NDA AUTHORIZED GENERIC	Strides Pharma Science Limited	64380-187-01	60 TABLET, COATED in 1 BOTTLE (64380-187-01)	2022-09-15
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547	NDA AUTHORIZED GENERIC	Strides Pharma Science Limited	64380-188-01	60 TABLET, COATED in 1 BOTTLE (64380-188-01)	2022-08-01

Accolate Drug Supply Chain Analysis

Last updated: February 19, 2026

Accolate, the brand name for the asthma medication zafirlukast, is a leukotriene receptor antagonist developed by AstraZeneca. Its primary active pharmaceutical ingredient (API) is zafirlukast. The supply chain for Accolate involves API manufacturers, formulation and packaging facilities, and distribution networks.

Who are the Primary API Manufacturers for Zafirlukast?

The production of zafirlukast API is a critical component of the Accolate supply chain. Several entities are involved in its synthesis, both historically and potentially for generic production.

• AstraZeneca was the originator and the primary manufacturer of zafirlukast API for its branded Accolate product. The company maintains robust quality control and manufacturing standards for its proprietary APIs. Specific details on their in-house API production sites for zafirlukast are not publicly disclosed for competitive reasons.
• Contract Manufacturing Organizations (CMOs) play a significant role in pharmaceutical API production. While specific CMOs currently manufacturing zafirlukast API for generic versions of Accolate are not always publicly identified, the nature of the pharmaceutical industry suggests reliance on specialized chemical synthesis companies. These CMOs must adhere to strict Good Manufacturing Practices (GMP) and undergo rigorous audits by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Companies like Lonza, Catalent, and Siegfried are examples of large CMOs that possess the capabilities for complex API synthesis, though their specific involvement with zafirlukast is not publicly detailed.
• Generic API Suppliers: Following patent expiry, multiple companies globally have entered or could enter the zafirlukast API market. India and China are significant hubs for generic API manufacturing due to cost efficiencies and established chemical synthesis expertise. Companies specializing in leukotriene antagonists or similar chemical classes may be involved. Identifying specific, current generic API suppliers often requires access to proprietary supply chain intelligence databases or detailed regulatory filings that list API sources for approved generic drug products.

What are the Key Formulation and Packaging Sites for Accolate?

Once the zafirlukast API is manufactured, it is formulated into the final dosage form (tablets) and packaged. This stage also involves stringent regulatory oversight to ensure product quality, stability, and patient safety.

• AstraZeneca's Manufacturing Network: For branded Accolate, AstraZeneca operates or contracts with manufacturing facilities that handle the drug product formulation, tablet compression, and final packaging. These sites are subject to the highest levels of regulatory compliance and quality assurance. Historically, AstraZeneca has utilized a global network of manufacturing sites, with specific locations for Accolate production varying over time and by region.
• Generic Drug Product Manufacturers: Companies producing generic versions of Accolate (zafirlukast tablets) will have their own designated formulation and packaging sites. These sites are typically overseen by the generic drug manufacturer.
  • Examples of Generic Formulators: Without naming specific generic Accolate manufacturers (as this can change rapidly based on market dynamics and regulatory approvals), common players in the generic tablet manufacturing space include Teva Pharmaceuticals, Mylan (now Viatris), Sun Pharmaceutical Industries, and Aurobindo Pharma. These companies operate large-scale tablet manufacturing and packaging lines that comply with GMP standards.
  • Geographic Distribution: Generic formulation and packaging can occur in various regions, including the United States, Europe, India, and China, depending on the target market and the manufacturer's operational strategy.

How is the Accolate Supply Chain Regulated?

The pharmaceutical supply chain for Accolate, like all prescription drugs, is heavily regulated by national and international health authorities.

• Good Manufacturing Practices (GMP): All facilities involved in the manufacturing of zafirlukast API, formulation of the drug product, and packaging must adhere to GMP guidelines. These regulations ensure that products are consistently produced and controlled according to quality standards. Regulatory bodies such as the FDA (21 CFR Parts 210 & 211), EMA, and others conduct regular inspections of manufacturing facilities.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows regulatory agencies to review the API information without AstraZeneca or generic manufacturers having to disclose proprietary details to the public.
• Abbreviated New Drug Applications (ANDAs): For generic versions of Accolate, manufacturers must submit an ANDA to the FDA. This application demonstrates that the generic drug is bioequivalent to the reference listed drug (Accolate) and that the manufacturing facilities and processes meet all regulatory requirements. The ANDA includes information about the API supplier and the drug product manufacturing site.
• International Council for Harmonisation (ICH) Guidelines: ICH guidelines, such as ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and ICH Q10 (Pharmaceutical Quality System), provide a harmonized framework for quality standards across different regions, impacting global API and drug product manufacturing.

What are the Potential Risks and Considerations in the Accolate Supply Chain?

The Accolate supply chain, like any complex pharmaceutical supply chain, faces several inherent risks.

• API Sourcing Concentration: If a significant portion of zafirlukast API production is concentrated with a limited number of suppliers, any disruption at those sites (e.g., regulatory issues, natural disasters, geopolitical instability) could lead to API shortages.
• Quality Control Failures: Lapses in quality control at any stage, from API synthesis to final packaging, can result in product recalls, regulatory sanctions, and patient harm.
• Geopolitical and Economic Factors: Trade disputes, changes in import/export regulations, currency fluctuations, and global economic downturns can impact the cost and availability of raw materials and finished products.
• Intellectual Property and Patent Landscape: While the primary patents for Accolate have expired, managing intellectual property surrounding manufacturing processes or specific polymorphs can still be relevant, particularly for generic manufacturers seeking to avoid infringement.
• Supply Chain Transparency: Lack of complete transparency regarding all tiers of the supply chain (e.g., suppliers of key starting materials for API synthesis) can obscure potential vulnerabilities.
• Counterfeiting and Diversion: Ensuring the integrity of the supply chain through serialization and track-and-trace systems is crucial to prevent counterfeit drugs from entering the market.

Key Takeaways

The supply chain for Accolate (zafirlukast) is characterized by its reliance on specialized API manufacturers and formulation/packaging sites, governed by stringent regulatory oversight. AstraZeneca, as the originator, maintains control over its branded product's supply chain. For generic versions, a network of contract manufacturers and generic drug companies are involved, primarily in regions with established chemical synthesis and pharmaceutical manufacturing capabilities like India and China. Regulatory compliance with GMP, DMF filings, and ANDA submissions are foundational to ensuring product quality and market access. Potential risks include API sourcing concentration, quality control failures, geopolitical factors, and the ongoing challenge of supply chain transparency and integrity.

Frequently Asked Questions

1. What is the primary active pharmaceutical ingredient in Accolate? The primary active pharmaceutical ingredient in Accolate is zafirlukast.

2. Which regulatory bodies oversee the manufacturing of Accolate's API and drug product? Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) oversee the manufacturing of Accolate's API and drug product.

3. Are there specific contract manufacturing organizations (CMOs) publicly identified as suppliers of zafirlukast API? Specific CMOs currently manufacturing zafirlukast API for generic versions of Accolate are not always publicly identified due to competitive and proprietary reasons.

4. What type of regulatory submission is required for generic versions of Accolate in the United States? Generic versions of Accolate require an Abbreviated New Drug Application (ANDA) to be submitted to the FDA.

5. What are the major risks associated with the zafirlukast API supply chain? Major risks include API sourcing concentration, quality control failures, geopolitical and economic factors, intellectual property issues, and supply chain transparency challenges.

Citations

[1] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. U.S. Government Publishing Office.

[2] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals. U.S. Government Publishing Office.

[3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2000). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7.

[4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2007). ICH Harmonised Tripartite Guideline: Pharmaceutical Quality System Q10.