Suppliers and packagers for generic pharmaceutical drug: cangrelor

cangrelor

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gland	CANGRELOR	cangrelor	POWDER;INTRAVENOUS	213551	ANDA	Gland Pharma Limited	68083-412-10	10 VIAL, SINGLE-DOSE in 1 CARTON (68083-412-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2025-08-11
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958	NDA	Chiesi USA, Inc.	10122-620-10	10 VIAL, SINGLE-USE in 1 CARTON (10122-620-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (10122-620-01)	2015-07-08

Suppliers for the Pharmaceutical Drug: Cangrelor

Last updated: July 30, 2025

Introduction

Cangrelor is an intravenous, reversible P2Y12 platelet inhibitor primarily used to reduce thrombotic complications during percutaneous coronary interventions (PCI). Marketed under the brand name Kengreal, cangrelor plays a pivotal role in acute care settings requiring rapid platelet inhibition. This article examines the global landscape of cangrelor suppliers, analyzing manufacturing credentials, market dynamics, and supply chain considerations that influence availability and pricing.

Overview of Cangrelor and Its Market

Developed by The Medicines Company, now part of Novartis, cangrelor received FDA approval in 2015. Its clinical utility lies in its rapid onset and offset of action—attributes critical during PCI procedures. Due to its acute indication profile, the supply chain involves specialized manufacturers capable of producing high-purity injectable pharmaceuticals under stringent regulatory standards.

Key Suppliers of Cangrelor

1. The Medicines Company / Novartis

Initially developed and marketed by The Medicines Company, cangrelor’s production was proprietary until acquisition by Novartis. Post-acquisition, Novartis gained exclusive rights to manufacture and distribute cangrelor globally (excluding certain markets). As of recent reports, Novartis oversees the manufacturing quality, supply, and distribution of cangrelor, leveraging its extensive global biopharmaceutical infrastructure to meet demand across hospitals and specialized healthcare facilities.

2. Contract Manufacturing Organizations (CMOs)

Due to the complex synthesis and high regulatory requirements, Novartis collaborates with specialized CMOs for cangrelor production:

• Pfizer: Known for its extensive contract manufacturing network, Pfizer has historically partnered with biopharmaceutical companies for sterile injectable drugs. It is plausible that Pfizer or similar firms assist in cangrelor synthesis under contract, though specific agreements are proprietary.

• Benchmarked Regulatory Compliance: CMOs involved must possess current Good Manufacturing Practice (cGMP) certification, ensuring product safety and efficacy.

3. Upcoming Suppliers and Generics

As of the current landscape, no generic versions of cangrelor have been approved or entered the market due to patent protections and the complexity of manufacturing. However, potential new entrants include:

• Emerging biotech firms specializing in hematological pharmaceuticals.
• Regional pharmaceutical companies seeking regulatory approval to manufacture cangrelor under licensing agreements.

Supply Chain and Geographical Concentrations

Supply is predominantly concentrated within North America and Europe, with Novartis managing distribution logistics to ensure hospital-level availability. Emerging markets may face delays or shortages depending on regulatory approvals and manufacturing capacities.

Regulatory and Patent Considerations

Cangrelor’s patent protection has historically limited competition. Patent expiry, expected in the late 2020s, could open doors for generic manufacturing, which would diversify supply sources. Concurrently, regulatory agencies such as the FDA and EMA rigorously oversee manufacturing standards for cangrelor, which constrains rapid entry of new suppliers.

Market Dynamics and Potential Disruptions

Supply stability depends on manufacturing capacity, patent status, and geopolitical factors. Disruptions—such as production halts, regulatory delays, or raw material shortages—could impact availability. Novartis’s strategic stockpiling and global manufacturing footprint mitigate some risks but cannot eliminate supply vulnerabilities.

Emerging Trends and Future Outlook

• Patent expiration may pave the way for generics, increasing supplier diversity and reducing costs.
• Biotech innovations might result in alternative platelet inhibitors, potentially influencing demand and supply.
• Supply chain digitization and exception management may improve responsiveness to shortages or recalls.

Conclusion

The supply chain for cangrelor is predominantly controlled by Novartis, leveraging its pharmaceutical manufacturing expertise. While current suppliers are limited, upcoming market entrants could alter the landscape post-patent expiration. Stakeholders must monitor regulatory developments, patent statuses, and manufacturing capacities to anticipate supply risks and opportunities.

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Key Takeaways

• Novartis is the primary and exclusive supplier of cangrelor globally, with manufacturing supported through specialized CMOs.
• No generic versions are currently available; patent protection limits new supplier entry.
• Supply chain stability hinges on manufacturing capacity, regulatory adherence, and geopolitical considerations.
• Patent expiry may introduce generic options, increasing supply diversity and reducing costs.
• Stakeholders should prepare for potential supply disruptions, especially in emerging markets.

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FAQs

1. Who are the main manufacturers of cangrelor?
The primary manufacturer is Novartis, which acquired the rights from The Medicines Company. The production involves collaboration with Contract Manufacturing Organizations (CMOs) that adhere to strict cGMP standards.

2. Are there generic versions of cangrelor available?
As of now, no generic versions have received regulatory approval owing to patent protections. The potential for generics exists post-patent expiry, anticipated in the late 2020s.

3. How does patent protection influence the supply of cangrelor?
Patent exclusivity limits competition, confining supply to patent holders. Expiry could foster market entry of generics, increasing supply options and reducing prices.

4. What risks could impact the global supply of cangrelor?
Manufacturing disruptions, raw material shortages, regulatory delays, and geopolitical issues can impair supply chains. Strategic stockpiling and diversified manufacturing minimize these risks.

5. Will emerging biotech companies enter the cangrelor market?
Potentially, especially after patent expiration. Current barriers include high manufacturing complexity and regulatory hurdles, but future entrants might capitalize on licensing agreements or biosimilar development.

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References

1. FDA. (2019). FDA approves Cangrelor for use in Patients Undergoing Percutaneous Coronary Intervention.
2. Novartis. (2022). Annual Report.
3. The Medicines Company. (2015). Cangrelor: Clinical Development and Approval.
4. European Medicines Agency. (2021). Cangrelor Summary of Product Characteristics.
5. MarketWatch. (2022). Pharma Patent Expirations and Generic Entry Forecasts.