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Suppliers and packagers for INQOVI
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INQOVI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Taiho Oncology | INQOVI | cedazuridine; decitabine | TABLET;ORAL | 212576 | NDA | Taiho Pharmaceutical Co., Ltd. | 64842-0727-9 | 1 BLISTER PACK in 1 CARTON (64842-0727-9) / 5 TABLET, FILM COATED in 1 BLISTER PACK | 2020-07-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: INQOVI
Introduction
INQOVI (decitabine and cedazuridine) is an oral chemotherapeutic agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of myelodysplastic syndromes (MDS) and certain types of acute myeloid leukemia (AML). The drug's unique formulation combines decitabine, a cytidine analog, with cedazuridine, a cytidine deaminase inhibitor, enabling effective oral administration. As a niche, high-demand pharmaceutical product, identifying reliable suppliers for INQOVI is critical for healthcare providers, distributors, and patients. This article explores key suppliers, manufacturing dynamics, and procurement considerations for INQOVI.
Manufacturers and Licensors of INQOVI
Takeda Pharmaceuticals
Takeda Pharmaceuticals, a global biopharmaceutical leader headquartered in Japan, is the sole manufacturer and licensor of INQOVI. The company developed INQOVI as part of its strategic focus on hematological malignancies and innovative oral treatments.
Takeda's manufacturing facility for INQOVI is located primarily in the United States, leveraging existing GMP (Good Manufacturing Practices) compliant facilities to ensure supply stability and quality. The company’s extensive research and development investments have positioned it as the principal source and distributor of INQOVI.
Licensing and Patent Rights
Takeda holds exclusive rights to INQOVI's patents and approval licenses, limiting third-party manufacturing unless under specific licensing agreements. These patents cover the composition, formulation, and specific delivery mechanisms of decitabine and cedazuridine combinations.
Global Supply Chain and Distribution Networks
Direct Distribution
Takeda manages direct distribution channels for INQOVI, using a combination of internal logistics and authorized pharmaceutical distributors. This approach ensures strict quality control and adherence to regulatory standards, facilitating consistent supply to hospitals, clinics, and pharmacies across major markets such as the U.S., Europe, and Asia.
Authorized Distributors and Wholesalers
Several licensed pharmaceutical wholesalers serve as authorized distributors of INQOVI, including:
- McKesson Corporation
- AmerisourceBergen
- Cardinal Health
These distributors maintain inventory, handle logistics, and facilitate timely delivery, especially in high-demand regions. They are also responsible for compliance with regulatory requirements and temperature-controlled storage.
Regional and Local Suppliers
In some territories, regional or local pharmaceutical companies may hold distribution licenses, ensuring access to INQOVI in remote markets. However, due to patent restrictions and supply agreements, these suppliers typically source their stock from authorized distributors or through direct imports from Takeda.
Authorized Procurement Channels
Regulatory Approvals and Import Regulations
Procurement of INQOVI must adhere to regional regulatory approvals. For example, in the U.S., it is approved under the NDA (New Drug Application) pathway. In countries where the drug is not yet approved, importation may be possible through compassionate use or special import licenses, usually coordinated with Takeda or local regulatory bodies.
Pharmaceutical Wholesalers
Healthcare providers generally procure INQOVI through licensed pharmaceutical wholesalers authorized by Takeda. These wholesalers maintain an assured supply chain and inventory management protocols, reducing the risk of counterfeit products.
Hospital and Oncology Network Purchasing
Major hospitals and oncology treatment centers often establish direct purchasing agreements or participate in centralized procurement programs. These arrangements ensure a stable supply, especially for ongoing treatment protocols involving INQOVI.
Key Suppliers of INQOVI
| Supplier Type | Major Players | Region | Notes |
|---|---|---|---|
| Manufacturer | Takeda Pharmaceuticals | Global | Sole manufacturer and licensor |
| Authorized Distributors | McKesson, AmerisourceBergen, Cardinal Health | North America | Primary supply chains for hospitals and pharmacies |
| Regional Suppliers | Local licensed pharma companies | Selected markets | Enable regional access, often sourcing from authorized distributors |
Supply Chain Considerations
- Patent exclusivity restricts manufacturing to Takeda or licensed partners.
- Manufacturing capacity and logistics influence availability, especially during pandemic-related disruptions.
- Regulatory alignment is essential for imports and regional distribution.
- Inventory management is critical for high-cost, low-volume drugs like INQOVI to prevent shortages.
Emerging Trends and Future Outlook
Potential for Generic Alternatives
Currently, INQOVI remains under patent protection, limiting generics. However, expiration of patents or licensing agreements could open opportunities for biosimilar or generic manufacturers, enhancing supply diversity and cost competitiveness.
Expansion of Supply Channels
Takeda has prioritized reliable supply chains and has begun expanding distribution networks to emerging markets, which may involve partnering with regional suppliers to meet global demand.
Supply Chain Resilience
The COVID-19 pandemic underscored vulnerabilities in global pharmaceutical supply chains. Efforts are underway to decentralize manufacturing and implement risk-mitigation strategies, ensuring consistent INQOVI availability.
Conclusion
As the sole manufacturer and licensor of INQOVI, Takeda Pharmaceuticals remains the central supplier of this oral chemotherapy agent. The company’s strategic use of authorized distributors, regional partners, and rigorous supply chain management ensures dependable access for healthcare providers globally. Understanding these supply dynamics enables stakeholders to optimize procurement strategies, mitigate shortages, and improve patient outcomes.
Key Takeaways
- Takeda is the exclusive manufacturer of INQOVI, holding patents and approval licenses.
- Reliable procurement depends on authorized distributors such as McKesson, AmerisourceBergen, and Cardinal Health.
- Regional suppliers play a critical role in market access, especially where direct Takeda distribution is limited.
- Regulatory compliance and supply chain resilience are essential for sustained availability.
- Future market dynamics may introduce biosimilars or generics, expanding supply options.
FAQs
1. Is INQOVI available from multiple manufacturers globally?
No. Currently, Takeda Pharmaceuticals is the sole manufacturer and licensor of INQOVI, with production rights protected under patents and exclusive licensing agreements.
2. How can healthcare providers ensure a reliable supply of INQOVI?
By establishing relationships with authorized distributors such as McKesson, AmerisourceBergen, and Cardinal Health, and maintaining inventory agreements aligned with regional regulatory standards.
3. Are there regional restrictions on purchasing INQOVI?
Yes. Procurement depends on regional regulatory approvals, import licenses, and distribution licenses, which may restrict direct importation and require local licensing.
4. Will the supply of INQOVI increase in the future?
Potentially. If patents expire or licensing agreements are expanded, biosimilar or generic options may emerge, increasing supply sources and reducing costs.
5. What risks threaten the supply chain of INQOVI?
Pandemic disruptions, manufacturing capacity limitations, logistical constraints, and regulatory delays pose risks to consistent supply. Diversification and strategic stockpiling are essential mitigation strategies.
Sources
[1] U.S. Food and Drug Administration (FDA). INQOVI (decitabine and cedazuridine) approval details.
[2] Takeda Pharmaceuticals. Official product information and licensing data.
[3] Pharmaceutical distribution company profiles and licensing frameworks.
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