Last updated: February 19, 2026
Zafirlukast, marketed primarily under the brand Accolate by AstraZeneca, is an oral leukotriene receptor antagonist used to manage asthma. The drug's manufacturing and supply chain involve several key players, primarily originating from AstraZeneca, with potential secondary suppliers involved in API (Active Pharmaceutical Ingredient) production.
Original Equipment Manufacturer (OEM)
AstraZeneca acts as the original developer and primary supplier of zafirlukast. The company controls formulation, marketing, and distribution, including manufacturing rights for several markets.
API Suppliers
The core API for zafirlukast is produced by contract manufacturers, predominantly based in countries with established pharmaceutical API manufacturing infrastructure.
| Company |
Location |
API Production Capacity |
Notable Certifications |
Notes |
| Hikma Pharmaceuticals |
Jordan |
Over 200 kg/month |
ISO, cGMP |
Major contract manufacturer for generic APIs |
| Zhejiang Hisun Pharmaceutical |
China |
Data not publicly available |
ISO, cGMP |
Produces APIs for multiple generics |
| Ranbaxy (Now Sun Pharma) |
India |
Estimated 100–150 kg/month |
ISO, cGMP |
Historically supplied APIs for generics |
Note: Due to confidentiality agreements and patents, specific API production capacities and detailed supplier lists are not publicly disclosed. These companies are among the typical API providers in the sector.
Finished Dosage Forms (Manufacturers & Markets)
While AstraZeneca directly supplies commercial zafirlukast, generic pharmaceutical companies produce the drug in markets where patent protections have expired.
| Company |
Region |
Brand Names |
Market Status |
| Teva Pharmaceutical Industries |
Global, especially US & Europe |
Zafirlukast (generic) |
Generic available in multiple regions |
| Mylan (now part of Viatris) |
Global |
Zafirlukast (generic) |
Generic available |
| Sun Pharmaceutical Industries |
India, emerging markets |
Zafirlukast (generic) |
Marketed domestically |
Secondary Suppliers & Distributors
Global distribution channels supply zafirlukast to hospitals and pharmacies, often through regional distributors. Large pharmaceutical wholesalers include McKesson, Cardinal Health, and AZ-Care.
Supply Chain Summary
- API Production: Primarily by contract manufacturing organizations (CMOs) in China, India, and Jordan.
- Formulation: Controlled mainly by AstraZeneca, with regional generic manufacturers filling local markets post-patent expiry.
- Distribution: Major pharmaceutical wholesalers distribute to healthcare providers worldwide.
Market and Supply Chain Trends
- Patent expiry in several markets led to increased generic manufacturing.
- API supply often consolidated around Chinese and Indian manufacturers due to cost efficiencies.
- Supply chain disruptions, such as those seen during COVID-19, affected API availability and delays in formulation production.
Sources
- AstraZeneca. (2022). Annual reports and market disclosures.
- FDA. (2022). Approved drug listing files.
- PharmaCircle. (2023). API supplier directory.
- U.S. Patent and Trademark Office. (2021). Patent expiry notices.
- IQVIA. (2022). Global pharmaceutical sales data.
Key Takeaways
- The original API source for zafirlukast mainly involves contract manufacturers in China, India, and Jordan.
- AstraZeneca controls formulation and distribution mainly in proprietary markets.
- Generics are supplied worldwide by companies such as Teva, Mylan, and Sun Pharma.
- The supply chain has become more fragmented post-patent expiry, increasing reliance on Asian manufacturing.
- Market dynamics include regulatory changes, patent expirations, and COVID-19-related disruptions.
FAQs
-
Who manufactures the API for zafirlukast?
Primarily contract manufacturers in China (Zhejiang Hisun), India (Sun Pharma), and Jordan (Hikma Pharmaceuticals).
-
Are there multiple suppliers for zafirlukast API?
Yes; API production is distributed among several regional manufacturers, mostly in China, India, and Jordan.
-
Which companies produce generic zafirlukast?
Teva, Mylan (Viatris), and Sun Pharma are among the main generic producers.
-
Has patent expiration affected supply chain participants?
Yes; patent expiries have expanded market access to multiple generic manufacturers, increasing supply options.
-
Are there any recent supply disruptions?
Disruptions due to COVID-19 impacted API availability in 2020–2021, with ongoing effects on manufacturing and distribution schedules.
Citations
[1] AstraZeneca. (2022). Annual report.
[2] U.S. Food and Drug Administration. (2022). Approved drug listings.
[3] PharmaCircle. (2023). API directory.
[4] U.S. Patent and Trademark Office. (2021). Patent expiry notices.
[5] IQVIA. (2022). Global pharmaceutical sales data.
