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Suppliers and packagers for generic pharmaceutical drug: idelalisib
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idelalisib
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858 | NDA | Gilead Sciences, Inc. | 61958-1701-1 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1) | 2014-07-23 |
| Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858 | NDA | Gilead Sciences, Inc. | 61958-1702-1 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1702-1) | 2014-07-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: IDELALISIB
Introduction
Idelalisib, marketed under the brand name Zydelig, is a targeted oral therapy used primarily for the treatment of various hematologic malignancies, notably chronic lymphocytic leukemia (CLL), follicular lymphoma, and small lymphocytic lymphoma. As a potent phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor, Idelalisib has become a significant asset within precision oncology. Ensuring a reliable supply chain for Idelalisib is critical for pharmaceutical companies, healthcare providers, and patients. This article explores the current landscape of suppliers involved in the manufacturing and distribution of Idelalisib, analyzing both the primary producers and secondary suppliers along the value chain.
Manufacturers of Idelalisib
1. Gilead Sciences, Inc.
Gilead Sciences holds the original patent and commercial rights for Idelalisib, with the FDA approval granted in 2014. As the main innovator, Gilead is the primary manufacturer of Idelalisib, overseeing its production, distribution, and commercialization globally. The company's extensive manufacturing infrastructure ensures a consistent supply of the drug to markets where it is approved, including the United States, European Union, and other territories.
2. Contract Manufacturing Organizations (CMOs)
Gilead partners with multiple Contract Manufacturing Organizations (CMOs) to bolster its production capacity and ensure supply continuity. These CMOs are specialized facilities capable of synthesizing complex chemical entities like Idelalisib, adhering to Good Manufacturing Practices (GMP). Prominent CMOs involved include:
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Fujifilm Diosynth Biotechnologies: Known for high-volume pharmaceutical manufacturing, potentially involved in active pharmaceutical ingredient (API) synthesis and formulation.
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Samsung Biologics: While primarily focused on biologics, Samsung's capacity may extend to chemical APIs as part of broad manufacturing collaborations.
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Catalent and Lonza: These organizations provide secondary manufacturing services, including formulation and fill-finish operations, essential for final product assembly.
3. API Suppliers and Intermediates
While Gilead conducts its own synthesis of Idelalisib's API, it also partners with specialized chemical suppliers for intermediates or may utilize multiple sources to mitigate supply risks. Potential API raw material suppliers include:
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Contract Chemical Suppliers in China and India: These regions dominate the global API supply chain, with companies offering active pharmaceutical ingredients that meet international compliance standards.
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Such suppliers often provide intermediates or bulk API for further formulation and packaging.
Distribution and Regional Suppliers
Following manufacturing, Idelalisib is distributed through Gilead’s global network or authorized distributors within regional markets. Distributors such as Medicept Pharmaceuticals or McKesson Corporation facilitate warehousing, logistics, and supply to hospitals and clinics.
In emerging markets, local pharmaceutical distributors and importers acquire Idelalisib through regional licensing agreements, often sourcing from Gilead’s authorized channels or regional API suppliers.
Regulatory and Supply Chain Considerations
The geopolitical landscape influences supplier operations. The U.S. and European markets impose strict regulations on API quality, manufacturing documentation, and stability testing, constraining sourcing options mainly to Gilead’s authorized facilities and qualified CMOs. Supply chain disruptions, exemplified by global crises like COVID-19, have pressed companies to diversify supplier bases to prevent shortages.
Furthermore, patent protections and exclusivity rights granted to Gilead restrict generic manufacturing, thus limiting the proliferation of direct suppliers outside authorized pharmaceutical companies. Nonetheless, after patent expiry or via licensing agreements, generic manufacturers can emerge as alternative suppliers.
Market Dynamics and Future Supply Perspectives
The future of Idelalisib supply hinges on several factors:
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Patent Expiry and Biosimilar Entry: Once patent protections lapse, multiple manufacturers will likely enter the market, increasing supply options and potentially reducing costs.
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Manufacturing Scale-up: Gilead’s capacity expansion and the development of new manufacturing facilities may influence the supply stability and regional availability.
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Quality and Compliance: Suppliers must adhere to stringent GMP standards to maintain market access; deviations can lead to supply disruptions or recalls.
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Global Geopolitical Factors: Trade disputes, tariffs, or export restrictions, particularly involving key API-producing countries such as China and India, can impact API supply and overall drug availability.
Conclusion
Gilead Sciences is the primary supplier of Idelalisib, supported by a network of CMOs and regional distributors. The complex geopolitical and regulatory environment, coupled with patent protections, constrains the number of active suppliers but creates potential avenues for competition post-patent expiry. Ensuring a resilient, compliant supply chain remains a strategic priority for stakeholders involved in Idelalisib’s lifecycle.
Key Takeaways
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Dominance of Gilead Sciences: As the innovator, Gilead controls the majority of Idelalisib production and supply, leveraging partnerships with CMOs to meet global demand.
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Role of CMOs and API Suppliers: Contract manufacturers and API suppliers, mainly based in China and India, are critical to maintaining supply continuity.
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Regulatory Constraints: Strict compliance standards limit the number of authorized suppliers, emphasizing the importance of quality assurance in manufacturing.
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Market Dynamics: Patent expirations and potential biosimilar entries will diversify supply sources, potentially reducing costs and increasing accessibility.
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Supply Chain Risks: Geopolitical tensions, global crises, and regulatory hurdles pose ongoing risks to the stability of Idelalisib supply, necessitating proactive risk mitigation strategies.
FAQs
1. Who are the main manufacturers of Idelalisib?
Gilead Sciences is the primary manufacturer, supported by various Contract Manufacturing Organizations (CMOs) responsible for synthesis, formulation, and distribution.
2. Are there generic alternatives to Idelalisib?
Currently, Idelalisib is protected by patents, with generic versions unlikely until patent expiry, after which multiple manufacturers may enter the market.
3. Which regions have the largest supply of Idelalisib?
The United States and European Union are the main markets, with regional distribution networks managed by Gilead and authorized distributors.
4. How does the global API supply chain affect Idelalisib availability?
Heavy reliance on API suppliers from China and India introduces supply risks, especially amid geopolitical or health crises.
5. What factors could influence future Idelalisib supply?
Patent expiration, manufacturing capacity expansion, regulatory policies, and geopolitical factors are key determinants of future supply stability.
References
- Gilead Sciences. (2014). FDA Approval of Zydelig (Idelalisib).
- U.S. Food and Drug Administration. (2014). Idelalisib (Zydelig) NDA Approval.
- European Medicines Agency. (2014). Zydelig (Idelalisib) Summary of Product Characteristics.
- Reports on API manufacturing in China and India from industry analyses. (2022).
- Gilead Sciences Annual Reports. (2022).
This article provides an authoritative overview of Idelalisib suppliers, designed to inform stakeholders about the current manufacturing landscape and future considerations for supply chain stability.
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