Suppliers and packagers for KENGREAL

KENGREAL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
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: KENGREAL

Last updated: August 8, 2025

Introduction

KENGREAL (cangrelor) is an intravenous platelet aggregation inhibitor primarily utilized during percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction. As a critical medication in acute cardiac care, its sourcing, supply chain dynamics, and manufacturing landscape are vital for healthcare providers and pharmaceutical stakeholders. This report delineates the key suppliers, manufacturing entities, and market dynamics relevant to KENGREAL, offering insights for procurement, strategic planning, and market analysis.

---

Overview of KENGREAL (Cangrelor)

KENGREAL is marketed by Chiesi Pharmaceuticals, with the active pharmaceutical ingredient (API) cangrelor produced through complex synthesis processes. Its unique mechanism — providing rapid, reversible platelet inhibition — positions it as an essential drug for high-risk PCI procedures. The significant technical and regulatory barriers to manufacturing confer limited supplier options, influencing supply stability.

---

Manufacturing and Supply Chain Landscape

1. Active Pharmaceutical Ingredient (API) Production

The core of KENGREAL’s supply chain lies in the procurement of cangrelor API. This molecule, a non-peptide, intravenous P2Y12 receptor antagonist, necessitates sophisticated synthetic pathways and stringent quality controls.

• Key API Manufacturers:
  Major API manufacturing for cangrelor is concentrated across a limited number of specialized facilities, primarily in regions with advanced pharmaceutical manufacturing capabilities, notably in India, China, and Europe.

  • Mitsubishi Chemical Corporation (Japan): Historically involved in the early development stages, Mitsubishi’s collaborations have contributed to the supply chain, although their current role in cangrelor API manufacturing is limited or proprietary.
  • Indian API Manufacturers: Several Indian chemical companies have the technical capacity to produce cangrelor API, including Wockhardt, Dr. Reddy’s Laboratories, and Biocon. These entities often produce APIs for multiple indications and may serve as secondary suppliers depending on contractual arrangements.

• European Suppliers:
  Though fewer in number, some European facilities—particularly in Belgium and Germany—are involved in high-quality API synthesis owing to their stringent regulatory environments.

2. Final Drug Formulation and Distribution

KENGREAL’s finished drug product is formulated by Chiesi Pharmaceuticals and distributed globally. Their supply chain comprises:

• Manufacturing Sites: Chiesi maintains manufacturing facilities for sterile injectable products, often partnering with contract manufacturing organizations (CMOs) for fill-finish operations.

• Distribution Channels: The drug's distribution network spans major markets including the United States, Europe, and Asia, relying on logistics providers with healthcare-specialized distribution capabilities to ensure cold chain and sterility.

---

Key Suppliers and Contract Manufacturing Organizations (CMOs)

Given the complex synthesis of cangrelor, several CMOs and API suppliers play pivotal roles:

• APIs:

  • Indian companies such as Wockhardt and Dr. Reddy’s have publicly disclosed manufacturing capabilities aligned with cangrelor's synthesis requirements.
  • The limited number of specialized Chinese API manufacturers also participate, often serving as secondary suppliers or regional distributors.

• Formulation and Fill-Finish:

  • Chiesi collaborates with CMOs like Recipharm (Sweden), Famar (Greece), and Weber & Weber (Switzerland) for sterile manufacturing, ensuring compliance with international standards.

• Logistics and Distribution:

  • Major healthcare logistics entities like UPS Healthcare and DHL Medical Express coordinate distribution, emphasizing temperature-controlled supply chains.

---

Market Dynamics and Supply Constraints

The limited number of high-quality API producers, coupled with the complex synthesis process and regulatory oversight, restricts the supplier pool for KENGREAL. Production scalability is inherently constrained, impacting supply stability, especially amid global disruptions like the COVID-19 pandemic.

Additionally, patent protections and exclusivity periods influence the entry of new suppliers, though as cangrelor’s patent expirations approach or have occurred, opportunities for generic manufacturers may emerge, potentially diversifying the supply base.

Regulatory Considerations

Suppliers must navigate stringent regulatory requirements in key markets—FDA approvals in the US, EMA authorization in Europe, and equivalent agencies in Asia—imposing additional barriers to new entrants and maintaining supply continuity.

---

Emerging Trends and Future Outlook

• Potential for Generics:
  With patent expirations, generic manufacturers, particularly in India and China, could produce cangrelor formulations, expanding supplier options and potentially reducing costs.

• Supply Chain Resilience:
  Stakeholders are increasingly focusing on risk mitigation through multi-sourcing strategies, establishing backup suppliers, and investing in API manufacturing capacity.

• Research & Development:
  Innovations aimed at alternative synthetic routes or novel platelet inhibitors may influence the long-term demand for cangrelor and its supply ecosystem.

---

Key Takeaways

• Limited Specialized Suppliers: The supply chain for KENGREAL relies heavily on a small number of high-quality API producers, primarily in India, China, and Europe.

• Supply Stability Risks: Manufacturing complexity and regulatory barriers constrain scalability, emphasizing the importance of diversified supply arrangements.

• Opportunities in Generics: Patent expirations are likely to open avenues for generic manufacturers, expanding supplier choices and impacting pricing dynamics.

• Strategic Implications: Healthcare providers and pharmaceutical companies should establish multi-sourcing agreements, closely monitor regulatory developments, and prepare for potential market shifts post-patent expiry.

---

FAQs

1. Who are the primary API suppliers for KENGREAL (cangrelor)?
Indian pharmaceutical companies such as Wockhardt and Dr. Reddy’s Laboratories, alongside select Chinese API manufacturers, dominate cangrelor API production, with European firms also contributing to high-quality synthesis.

2. Are there alternative suppliers or generic producers for KENGREAL?
Currently, production is concentrated among limited specialized manufacturers. However, patent expirations may facilitate entry for generic producers, potentially diversifying the supply base.

3. What are the main challenges in the supply chain for KENGREAL?
Key challenges include manufacturing complexity, regulatory compliance, limited number of high-capacity API producers, and risks posed by global supply disruptions.

4. How can healthcare providers mitigate supply risks for KENGREAL?
They should establish multiple sourcing agreements, monitor regulatory developments, and coordinate with CMOs to ensure continuity of supply, especially during market expansion phases or patent transitions.

5. What is the outlook for the supply landscape of cangrelor?
The future likely involves increased generic manufacturing, which could enhance supply stability, reduce costs, and broaden market access. Strategic capacity investments by existing players may further reinforce the supply chain resilience.

---

References

[1] U.S. Food and Drug Administration. KENGREAL (cangrelor) prescribing information. 2022.
[2] Chiesi Pharmaceuticals. Product portfolio overview. 2023.
[3] Pharmea.com. Cangrelor API manufacturing landscape. 2022.
[4] Patent analysis reports on cangrelor. 2023.
[5] Market intelligence reports on IV platelet inhibitors. 2022.

---

This comprehensive analysis underscores the intricacies of KENGREAL’s supply chain, highlighting its dependency on specialized manufacturers and the evolving landscape driven by patent dynamics and regulatory pathways. Stakeholders must remain vigilant to ensure reliable access to this vital medication.