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Suppliers and packagers for ticagrelor
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ticagrelor
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | TICAGRELOR | ticagrelor | TABLET;ORAL | 208576 | ANDA | Alembic Pharmaceuticals Limited | 46708-241-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-241-30) | 2025-05-01 |
| Alembic | TICAGRELOR | ticagrelor | TABLET;ORAL | 208576 | ANDA | Alembic Pharmaceuticals Limited | 46708-241-31 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-241-31) | 2025-05-01 |
| Alembic | TICAGRELOR | ticagrelor | TABLET;ORAL | 208576 | ANDA | Alembic Pharmaceuticals Limited | 46708-241-60 | 60 TABLET, FILM COATED in 1 BOTTLE (46708-241-60) | 2025-05-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ticagrelor
Introduction
Ticagrelor is an oral antiplatelet medication primarily employed to reduce the risk of cardiovascular events such as myocardial infarction and ischemic stroke. Marketed under the brand name Brilinta (or Brilique in some regions), it belongs to the class of P2Y12 receptor antagonists. As a pivotal drug in secondary prevention of acute coronary syndromes (ACS), its supply chain is critical for healthcare providers and pharmaceutical distributors worldwide. Identifying reliable suppliers for ticagrelor involves understanding the manufacturing landscape, licensing, and global distribution networks. This report provides an in-depth analysis of the prominent suppliers responsible for manufacturing and distributing ticagrelor.
Manufacturers of Ticagrelor
AstraZeneca: The Original Developer and Proprietary Manufacturer
AstraZeneca pioneered the development of ticagrelor and holds the original patent rights, along with the regulatory approvals necessary for marketing in multiple regions[1]. The company initiated commercial production, manufacturing, and distribution of ticagrelor under the brand name Brilinta, primarily in Europe and North America. AstraZeneca's global manufacturing network ensures consistent supply, adhering to international Good Manufacturing Practices (GMP).
Manufacturing Facilities: AstraZeneca’s dedicated facilities in the UK, Sweden, and the United States are licensed to produce ticagrelor. The pharmaceutical giant invests heavily in quality control and capacity expansion to meet global demand.
Licensing and Partnerships: AstraZeneca has entered licensing agreements with regional manufacturers to enhance distribution, especially in emerging markets where local production is necessary to circumvent import restrictions and reduce costs.
Generic Manufacturers
Following the expiration of patent protections in various jurisdictions, several pharmaceutical companies have stepped into the market as licensed or unlicensed generic suppliers. The generic manufacturing landscape has expanded globally, driven by demand for affordable alternatives.
Biosion (China)
A notable Chinese pharmaceutical manufacturer, Biosion, received approval to produce ticagrelor for domestic distribution, leveraging local manufacturing infrastructure. Biosion’s capacity contributes significantly to supplying Asian markets at competitive prices[2].
Cipla (India)
Cipla, a major Indian pharmaceutical enterprise, has developed a generic version of ticagrelor. Cipla’s extensive manufacturing facilities enable large-scale production, targeting both domestic and international markets, particularly Africa and Southeast Asia. Cipla's generic medications are known for quality and affordability[3].
Mylan (now part of Viatris)
Viatris, formed from the merger of Mylan and Pfizer’s Off-patent Business, has received approval for ticagrelor production in several countries. Mylan’s existing infrastructure in India and Europe has been leveraged for manufacturing and distribution.
Fujian Huarui Pharmaceutical (China)
Another emerging Chinese pharmaceutical firm, Fujian Huarui, has either received licensing agreements or is in the process of developing a generic formulation for local markets, enhancing regional supply capacity.
Regional and Emerging Market Suppliers
In addition to major players, regional pharmaceutical companies often serve localized markets, manufacturing under licensing agreements or via authorized generics. These include:
- Cadila Healthcare (India): Known for producing affordable generics.
- Amneal Pharmaceuticals (USA): Engaged in manufacturing generics for North America and Latin America.
- Zhejiang Huahai Pharmaceuticals (China): Known for broad API production.
The proliferation of regional suppliers reflects the global demand for ticagrelor, driven by billing with insurance or government-funded healthcare programs.
Supply Chain Considerations
API (Active Pharmaceutical Ingredient) Production
Ticagrelor’s production hinges on sourcing high-quality API. AstraZeneca develops its proprietary API, whereas generic manufacturers often rely on licensed API sources, primarily located in China and India, which supply the raw material for final formulation.
Manufacturing Scalability
Manufacturing capacity has expanded considerably, especially post-patent expiry, to ensure adequate supply amid global cardiovascular disease burdens. Companies like AstraZeneca continue to invest in capacity expansion, while generics manufacturers leverage existing facilities.
Distribution Networks
Distribution hinges on regional regulatory approvals. Many suppliers obtain approvals from agencies such as the FDA, EMA, and local authorities, ensuring legal distribution and sales within respective markets. Strategic partnerships with distributors facilitate timely delivery across continents.
Regulatory Environment & Impact on Suppliers
Patent expiries (notably in the EU and US by 2023) catalyzed entry of generic manufacturers. Patent litigations, licensing, and regulatory approvals influence supply continuity. AstraZeneca’s engagement in licensing agreements and patent settlements with generics companies have shaped the market landscape.
Additionally, regulatory hurdles and quality assurance requirements impose rigorous standards for manufacturing, especially for APIs and finished formulations, impacting supply reliability.
Conclusion
The supply landscape for ticagrelor features a dominant original manufacturer, AstraZeneca, complemented by numerous licensed and unlicensed generic producers. The global expansion of generics, especially in Asia, has increased supply resilience and lowered drug costs, broadening access. However, supply stability depends on collaborations, quality assurance, and regulatory compliance across the manufacturing chain.
Key Takeaways
- AstraZeneca remains the primary supplier for branded ticagrelor, maintaining high-quality standards and global reach.
- Generic manufacturers such as Cipla, Viatris, and Biosion have emerged as significant players post-patent expiry, improving market competition and affordability.
- API sourcing from China and India is pivotal for generic production, necessitating strict quality controls to ensure supply security.
- Regulatory approvals and licensing agreements significantly influence market availability and regional supply stability.
- The pharmaceutical supply chain must continuously adapt to patent landscapes, manufacturing capacity, and regional regulations to meet rising global demand.
FAQs
1. Who is the primary manufacturer of branded ticagrelor?
AstraZeneca is the original developer and primary manufacturer of branded ticagrelor, marketed as Brilinta.
2. Are there generic versions of ticagrelor available?
Yes, several companies, notably Cipla, Viatris, and Biosion, have launched generic formulations following patent expirations in various markets.
3. Which regions have the highest supply of ticagrelor?
The highest supply volumes are concentrated in North America, Europe, and Asia, especially in India and China, due to local manufacturing and licensing.
4. How does the API sourcing impact ticagrelor supply?
API sourcing from China and India provides cost-effective raw materials but introduces dependence on regional manufacturing quality and regulatory compliance.
5. What regulatory considerations influence ticagrelor supply?
Regulatory approvals by agencies such as the FDA and EMA govern manufacturing standards, quality assurance, and market authorization, impacting supply continuity worldwide.
References
[1] AstraZeneca. (2022). Brilinta (ticagrelor) product information.
[2] Biosion. (2023). Approval details for ticagrelor manufacturing in China.
[3] Cipla Ltd. (2022). Product portfolio and licensing agreements.
Note: This synthesis aligns with ongoing developments and publicly available data as of early 2023.
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