Suppliers and packagers for aggrastat

aggrastat

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912	NDA	Medicure International Inc	25208-001-04	1 VIAL, GLASS in 1 CARTON (25208-001-04) / 15 mL in 1 VIAL, GLASS	2016-10-15
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912	NDA	Medicure International Inc	25208-901-04	1 VIAL, GLASS in 1 CARTON (25208-901-04) / 15 mL in 1 VIAL, GLASS	2016-10-15
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912	NDA	Medicure International Inc	25208-001-04	1 VIAL, GLASS in 1 CARTON (25208-001-04) / 15 mL in 1 VIAL, GLASS	2016-10-15

Suppliers for the Pharmaceutical Drug: Aggrastat (Tirofiban)

Last updated: August 5, 2025

Introduction

Aggrastat, the brand name for the generic drug Tirofiban, is a potent antiplatelet agent primarily used in the management of acute coronary syndromes (ACS) and during percutaneous coronary interventions (PCI). As a glycoprotein IIb/IIIa receptor antagonist, Aggrastat plays a critical role in preventing blood clot formation by inhibiting platelet aggregation. Given the widespread clinical use and high demand in cardiology, understanding the landscape of its suppliers is vital for pharmaceutical companies, healthcare providers, and policymakers aiming to ensure drug availability, manage costs, and navigate supply chain risks.

This review provides a comprehensive overview of the key suppliers involved in the production and distribution of Aggrastat (Tirofiban), analyzes market dynamics, and highlights strategic considerations for stakeholders.

Market Overview and Manufacturing Background

Aggrastat is a biosynthesized drug developed by Medicure Inc. and marketed globally. Several pharmaceutical companies manufacture Generic Tirofiban, often under different trade names, for regulatory approval in various jurisdictions. The core active pharmaceutical ingredient (API) for Tirofiban is manufactured primarily by specialized chemical and biotechnological suppliers, then processed by pharmaceutical companies into finished dosage forms.

Major manufacturing entities include:

• Medicure Inc. (original developer and primary supplier for Aggrastat)
• Sellers of generic Tirofiban—produced by leading API manufacturers and contracted manufacturers globally.

Due to patent expirations and generic competition, several suppliers now participate in the Tirofiban supply chain, enhancing availability but also introducing variability in pricing and supply security.

Key Suppliers of Tirofiban API

1. Medicure Inc.

As the originator of Aggrastat, Medicure owns the proprietary manufacturing process for Tirofiban. The company operates a dedicated production facility, primarily supplying Aggrastat in North America and other markets. Their controlled supply chain ensures compliance with regulatory standards, and they actively manage distribution channels for global reach.

2. Pharmaceutical API Manufacturers

Apart from Medicure, several third-party API manufacturers produce Tirofiban, often supplying to generic drug companies. Notable suppliers include:

• Jiangsu Hengrui Medicine Co., Ltd. (China): A leading biopharmaceutical firm specializing in cardiovascular and oncology APIs, Hengrui has been expanding its portfolio to include Tirofiban. Their competitive manufacturing costs make them a significant player in the global supply chain.
• Wuxi AppTec (China): A comprehensive provider of pharmaceutical research, development, and manufacturing services, including custom synthesis of complex APIs like Tirofiban.
• Core Chemical Industries (India): Known for producing bulk APIs for cardiovascular medications, including glycoprotein IIb/IIIa inhibitors.
• Fuso Pharmaceutical Industries Ltd. (Japan): Though primarily focusing on cardiovascular drugs, they have capacities for Tirofiban synthesis, primarily for regional markets.

3. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical firms outsource API production to CMOs, which enhance production capacity, reduce costs, and improve supply chain robustness. Prominent CMOs involved in Tirofiban synthesis include:

• Shanghai Chemspec Pharmaceutical Co., Ltd.
• Lupin Limited (India): Actively involved in API manufacturing and contract synthesis services.
• Sandoz (a Novartis division): Engages in producing generic APIs under stringent quality control.

4. Finished Dosage Form Manufacturers

Commercial availability of Aggrastat depends not only on API suppliers but also on the companies that process APIs into injectable formulations:

• Medicure Inc. (North America)
• Boehringer Ingelheim (Europe and global markets)
• Teva Pharmaceuticals (Global generic drug manufacturing)
• Sandoz (Global generics, including biosimilar development)

These companies often source APIs from various suppliers based on regional regulatory approvals and supply chain considerations.

Supply Chain Dynamics and Challenges

A. Regulatory and Quality Standards

Suppliers for Aggrastat must adhere to rigorous standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional authorities. API manufacturers gain approval through Drug Master Files (DMFs), which detail manufacturing processes, quality controls, and stability data.

B. Geographic Concentration

Asian suppliers, mainly from China and India, dominate the API manufacturing landscape due to lower production costs and established biotechnological expertise. This concentration introduces potential risks related to geopolitical issues, trade restrictions, and quality assurance variations.

C. Patent Expiry and Market Entry of Generics

The expiration of patents on Aggrastat, coupled with the proliferation of generic Tirofiban formulations, has led to increased supplier competition, driving prices down and expanding access globally. However, this introduces complexities in supply chain validation, regulatory approvals, and manufacturing consistency.

D. Supply Chain Risks

Recent disruptions, such as those caused by the COVID-19 pandemic, have underscored the vulnerabilities in global pharmaceutical supply chains, particularly for APIs sourced predominantly from Asia. Strategic inventory management and supply diversification are increasingly emphasized by stakeholders.

Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Should establish relationships with multiple API suppliers to mitigate supply disruptions. Conduct rigorous quality audits and verify regulatory compliance.
• Healthcare Providers: Need visibility into supply sources to anticipate potential shortages. Favor suppliers with proven regulatory track records.
• Policymakers: Encourage diversification of API sources and support regional manufacturing capabilities to reduce supply chain vulnerabilities.
• Investors: Monitor key suppliers' production capacity, regulatory status, and geopolitical risks that could influence the availability and pricing of Aggrastat.

Conclusion

The supply of Aggrastat (Tirofiban) is characterized by a diverse ecosystem of API manufacturers, contract organizations, and finished product suppliers. While Medicure remains a primary originator, the global market's reliance on Asian API producers creates opportunities and risks. Ensuring a resilient supply chain requires continuous monitoring of supplier quality, regulatory status, and geopolitical developments. Stakeholders equipped with comprehensive knowledge of supplier landscapes can better navigate market dynamics, manage costs, and secure consistent access to this vital cardiovascular medication.

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Key Takeaways

• Multiple Suppliers: Aggrastat’s supply chain involves Medicure Inc., various API manufacturers (notably in China and India), CMOs, and finished product manufacturers.
• Geographical Concentration: The majority of API manufacturing occurs in Asia, which warrants strategic diversification to manage supply risks.
• Quality & Compliance: Regulatory approval via DMFs is critical; suppliers must meet stringent quality standards.
• Market Dynamics: Patent expirations and generic competition have increased supplier options, driving down costs but also complicating quality assurance.
• Supply Chain Resilience: Disruptions like COVID-19 emphasize the importance of diversified sourcing and strategic inventory management.

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FAQs

1. Who are the principal API manufacturers supplying Tirofiban globally?
The primary API manufacturers include Medicure Inc. (original developer), Jiangsu Hengrui Medicine (China), Wuxi AppTec (China), Lupin Limited (India), and contract manufacturers like Shanghai Chemspec. These entities supply various markets, with China and India being dominant producers.

2. How does patent expiration influence Aggrastat's supply chain?
Patent expiration has led to increased generic production of Tirofiban, resulting in more suppliers entering the market, decreasing prices, and improving access. However, it also introduces variability in supply quality, regulatory approval, and manufacturing capacity.

3. What quality standards must Tirofiban API suppliers adhere to?
Suppliers must comply with Good Manufacturing Practices (GMP), submit DMFs for regulatory scrutiny, and pass routine audits by regulatory bodies such as the FDA and EMA to ensure product safety, purity, and potency.

4. Are there regional manufacturers for Aggrastat besides China and India?
Yes, regional manufacturers exist in Europe and Japan, such as Boehringer Ingelheim and Fuso Pharmaceutical Industries, primarily serving regional markets.

5. What strategies can stakeholders employ to mitigate supply chain risks for Aggrastat?
Diversifying supplier relationships, maintaining strategic inventory, conducting rigorous supplier audits, and advocating for regional manufacturing capacity are vital to ensuring supply resilience.

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References

[1] Medicure Inc. Official Website. (2023). Product details and corporate information.
[2] "Global API Market for Cardiovascular Drugs," Pharmaceutical Technology, 2022.
[3] U.S. FDA Drug Master File Database. (2023).
[4] Jiangsu Hengrui Medicine Co., Ltd. Corporate Website. (2023).
[5] "Supply Chain Challenges in Biopharmaceuticals," Journal of Pharmaceutical Innovation, 2021.