Suppliers and packagers for generic pharmaceutical drug: ZAFIRLUKAST

ZAFIRLUKAST

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	Strides Pharma Science Limited	64380-177-01	60 TABLET, FILM COATED in 1 BOTTLE (64380-177-01)	2023-01-02

Suppliers for the Pharmaceutical Drug: Zafirlukast

Last updated: July 27, 2025

Introduction

Zafirlukast is a leukotriene receptor antagonist primarily prescribed for the prophylaxis and management of chronic asthma. Developed by AstraZeneca under the brand name Accolate, zafirlukast modulates inflammatory responses in the airways, providing an alternative or adjunct to inhaled corticosteroids. The global supply chain for zafirlukast involves a network of manufacturers and suppliers that span the pharmaceutical value chain—from active pharmaceutical ingredient (API) producers to finished drug product manufacturers. Ensuring a reliable supply of zafirlukast is critical for healthcare providers, especially amidst increasing global demand for respiratory therapeutics.

This analysis explores key suppliers involved in the production of zafirlukast, focusing on API manufacturing, formulation, and distribution, as well as the strategic considerations that influence the drug’s supply chain stability.

Active Pharmaceutical Ingredient (API) Suppliers

Major API Manufacturers

The core component of zafirlukast’s supply chain is the API manufacturer. Historically, AstraZeneca developed and initially manufactured the API for zafirlukast. However, as generic competition and supply chain globalization increased, other pharmaceutical and chemical companies have entered the market.

AstraZeneca:
As the original developer, AstraZeneca remains a pivotal supplier of the API, either directly or through licensed partnerships. Manufacturing is often conducted at their facilities in Europe and the United States, adhering to stringent Good Manufacturing Practices (GMP). AstraZeneca maintains tight control over API supply, which is a significant factor in the drug’s availability.

Contract Manufacturing Organizations (CMOs):
Several CMOs globally have obtained licenses or manufacturing rights to produce zafirlukast API under contractual agreements. Notable companies include:

• China-based API producers:

  • North China Pharmaceutical Group Corporation (CCPC)
  • Shandong Xinhua Pharmaceutical Company
    These firms are increasingly significant given China’s expanding role in global API supply, offering cost-effective, large-scale manufacturing.

• India-based API manufacturers:

  • Laurus Labs
  • Cadila Healthcare
  • Granules India
    India has a growing API manufacturing sector, with several firms producing high-quality APIs for global export, including leukotriene receptor antagonists.

API Quality and Regulatory Standards

API suppliers must meet rigorous regulatory standards, including compliance with pharmacopoeial specifications and GMP. The quality and consistency of the API significantly impact the efficacy and safety profile of the final product. Suppliers often seek regulatory approvals from agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Pharmaceutical and Medical Device Agency (PMDA) in Japan.

Formulation and Final Dosage Form Suppliers

Finished Drug Manufacturing

Once the API is procured, pharmaceutical companies or Contract Manufacturing Organizations (CMOs) produce zafirlukast in tablet form. AstraZeneca itself operates multiple manufacturing plants globally, including facilities in the US and Europe, capable of scaling production based on demand.

Key Contract Manufacturing & Packaging Firms

• Capsule and tablet manufacturers:
  Several global CMOs with expertise in dry powder formulations and oral tablet production include:

  • Catalent (US, Europe, Asia)
  • STADA Arzneimittel
  • Laboratorios Grifols

• Regional manufacturers:
  Local and regional pharmaceutical companies, particularly in India and China, have started manufacturing zafirlukast formulations for generic markets, expanding supply accessibility in emerging markets.

Distribution and Supply Chain Considerations

Distribution Channels

Distribution of zafirlukast spans wholesale drug distributors, pharmacies, hospitals, and healthcare providers. Ensuring a steady supply chain requires robust logistics networks with cold chain management where necessary, although zafirlukast has a stable formulation that does not require refrigeration.

Market Dynamics Impacting Suppliers

• Patent expiries:
  Zafirlukast faced patent expirations in various regions, promoting generic manufacturing and expanding the supplier base. This increased competition benefits healthcare systems through lower prices but also disperses supply sources.

• Regulatory approvals and recalls:
  Any quality concern or regulatory restriction at a key API or formulation plant can disrupt supply. For instance, past quality issues with certain Chinese API producers led to temporary shortages.

• Geopolitical factors:
  Trade tensions, tariffs, and export restrictions, particularly involving China and India, influence the availability and cost of API supply.

Emerging Trends in Supply Chain Resilience

Due to recent global disruptions—such as the COVID-19 pandemic—pharma companies are increasingly diversifying their API and formulation suppliers. Strategic stockpiling, supplier qualification programs, and development of regional manufacturing facilities mitigate risks of shortages.

Regulatory and Supply Chain Challenges

• Regulatory compliance:
  Ensuring API and finished product compliance with varying regulatory standards globally remains complex and costly. Suppliers must navigate differing requirements of the US, EU, and other markets.

• Supply chain transparency:
  Recent initiatives aim to improve supply chain transparency, enhancing oversight over API sourcing to ensure high-quality, consistent supply.

• Intellectual property considerations:
  Although zafirlukast mostly faces generic competition, some formulations or manufacturing processes are protected by patents, impacting supplier options.

Market Outlook and Strategic Considerations

The global demand for zafirlukast remains steady, especially in markets where inhaler access is limited or in regions prioritizing affordable asthma medications. The expansion of API manufacturing capacity in China and India, combined with the emergence of regional formulators, broadens supply options. However, maintaining supply chain resilience against geopolitical, regulatory, and quality risks is critical for sustained availability.

Pharmaceutical companies are incentivized to develop long-term partnerships with multiple suppliers and to establish regional manufacturing hubs. Such strategies reduce dependence on a single source and help mitigate supply disruptions.

Key Takeaways

• Diverse supplier base:
  The supply of zafirlukast relies on both original manufacturer AstraZeneca and several generic API producers in China and India. The increasing role of CMOs enhances the global supply capacity.

• Regulatory compliance is paramount:
  Suppliers must adhere to strict GMP and pharmacopoeial standards; deviations can result in shortages.

• Market dynamics influence supply stability:
  Patent expirations and competition have expanded the supplier base, but geopolitical and trade issues remain risks.

• Supply chain resilience:
  Recent disruptions have emphasized the importance of diversified sourcing, regional manufacturing, and strategic inventories.

• Future outlook:
  Expansion of API production in Asia and strict regulatory oversight will shape the supply landscape, ensuring broader access but requiring vigilant risk management.

FAQs

1. Who are the primary API suppliers for zafirlukast?
   Original production was by AstraZeneca; now, several Chinese and Indian API manufacturers, including North China Pharmaceutical Group, Shandong Xinhua Pharmaceutical, Laurus Labs, and Cadila Healthcare, supply the API.

2. Are there alternatives to zafirlukast in the market?
   Yes, leukotriene receptor antagonists like montelukast (by Merck) are common alternatives. The choice depends on clinical considerations and regional formulary preferences.

3. What risks threaten zafirlukast’s supply chain?
   Supply risks include manufacturing disruptions, regulatory non-compliance, geopolitical tensions, export restrictions, and quality issues at API plants.

4. How has recent patent expirations affected suppliers?
   Patent expiries have facilitated entry of generic manufacturers, broadening the supplier base and reducing costs, but increasing the importance of quality and regulatory oversight.

5. What strategies are companies employing to ensure stable zafirlukast supply?
   Companies are diversifying supplier portfolios, expanding regional manufacturing, securing multiple supply agreements, and maintaining safety stock levels.

References

1. [1] AstraZeneca. (2022). Zafirlukast Product Information.
2. [2] U.S. Food and Drug Administration. (2023). Drug Approvals and Information.
3. [3] Global Pharma Market Report. (2021). API Manufacturing Trends.
4. [4] WHO. (2020). Quality Assurance of Active Pharmaceutical Ingredients.
5. [5] IQVIA. (2022). Global API Supply Chain Analysis.