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Suppliers and packagers for zydelig
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zydelig
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 |
ppliers for the Pharmaceutical Drug: Zydelig
Introduction
Zydelig (idelalisib) is a targeted cancer therapy developed by Gilead Sciences, approved primarily for treating certain hematologic malignancies, including chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and small lymphocytic lymphoma (SLL). As a PI3K delta inhibitor, Zydelig's manufacturing and supply chain are critical for ensuring quality, availability, and compliance with regulatory standards. This report provides an in-depth analysis of suppliers associated with Zydelig, encompassing active pharmaceutical ingredient (API), excipients, packaging components, and contract manufacturing organizations involved in production stages, alongside strategic considerations for stakeholders.
Key Raw Material Suppliers for Zydelig
Active Pharmaceutical Ingredient (API) Suppliers
Zydelig’s efficacy hinges on the quality of the API, idelalisib. Gilead Sciences maintains a robust supply chain for API manufacturing, sourcing from multiple chemical producers to ensure supply continuity and mitigate risks associated with single-source dependency.
1. API Synthesis and Contract Manufacturers
Gilead collaborates with specialized contract manufacturing organizations (CMOs) known for their expertise in fine chemical synthesis and complex molecule production. These CMOs include firms with Good Manufacturing Practice (GMP) certification capable of producing high-purity API batches adhering to stringent quality standards.
2. Key Chemical Suppliers
While proprietary synthesis routes are guarded, chemical intermediates used in idelalisib production are often supplied by specialized chemical suppliers with capabilities in producing complex heterocyclic compounds. Examples include firms that supply pyrimidine derivatives and halogenated aromatic intermediates typically involved in idelalisib synthesis.
Excipients and Formulation-Related Suppliers
Zydelig's formulation comprises inert excipients that facilitate drug stability, bioavailability, and packaging compatibility.
1. API Stabilizers and Fillers
Suppliers of excipients such as microcrystalline cellulose, lactose, and magnesium stearate are global flavor compounds, with established vendors that supply pharmaceutical-grade materials meeting pharmacopeial standards (USP, EP).
2. Coating and Packaging Materials
Blister packs, foil seals, and coating agents are supplied by manufacturers specializing in pharmaceutical-grade packaging solutions, ensuring tamper-evidence, protection from moisture, and patient safety.
Contract Manufacturing & Packaging Partners
Gilead often outsources manufacturing, formulation, and packaging to CMOs with specialized equipment for tablet compression, coating, and quality assurance.
1. Contract Manufacturing Organizations (CMOs)
CMOs such as Eli Lilly, Catalent, or Recipharm may be involved in large-scale fill-finish operations, including tablet production, coating, and packaging. These partners possess certifications such as ISO 9001, ISO 13485, and GLP compliance.
2. Packaging and Distribution
Specialized packaging firms ensure that Zydelig’s packaging complies with regulatory standards, providing barcode labeling for traceability and child-resistant features to prevent accidental ingestion.
Strategic Supplier Considerations
Diversification and Risk Management
Gilead’s strategy involves multiple suppliers at each stage—API synthesis, intermediates, excipients, and packaging—to prevent supply disruptions, especially considering the complex and sensitive nature of cancer therapies.
Quality and Regulatory Compliance
Suppliers must adhere to strict Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP) standards. Regulatory audits by Gilead and health authorities ensure compliance and mitigate risks associated with substandard materials.
Innovation and Supply Chain Resilience
Gilead invests in supplier development and cultivates partnerships with emerging chemical and biotech firms to enhance supply chain resilience against geopolitical, technological, or market disruptions.
Emerging Trends and Future Outlook
The pharmaceutical landscape for oncology drugs like Zydelig increasingly favors localized manufacturing and regional supply hubs to reduce dependency on global supply chains. Additionally, advances in sustainable manufacturing and the adoption of continuous processing methods aim to enhance supplier capabilities. Gilead and other pharmaceutical companies are also exploring alternative synthesis routes and API production platforms aimed at reducing costs and enhancing supply scalability.
Key Takeaways
- Multiple suppliers ensure supply stability for Zydelig’s key components, notably the API, excipients, and packaging materials.
- Partnering with GMP-compliant contract manufacturers mitigates quality and regulatory risks, critical for oncology therapies.
- Supply chain diversification is a strategic priority amid geopolitical uncertainties and manufacturing complexities.
- Innovation in manufacturing processes and localization efforts contribute to sustainability and resilience.
- Rigorous supplier qualification and audits guarantee compliance with regulatory standards, safeguarding patient safety and product integrity.
FAQs
1. Who are the primary suppliers of Zydelig's API?
Gilead collaborates with specialized contract manufacturing organizations experienced in complex chemical synthesis to produce idelalisib, ensuring high purity and quality compliance. The specific suppliers are confidential but are certified GMP producers globally.
2. Are there alternative API suppliers for Zydelig?
Yes, Gilead maintains a diversified supplier portfolio, including multiple certified suppliers across different regions, reducing dependence on a single source and ensuring supply continuity.
3. What role do excipient suppliers play in Zydelig’s supply chain?
Excipients like microcrystalline cellulose, lactose, and magnesium stearate supplied by pharmaceutical-grade vendors contribute to the stability, bioavailability, and manufacturability of Zydelig tablets.
4. How does Gilead ensure the quality of its suppliers?
Gilead conducts rigorous qualification processes, including audits, quality assessments, and ongoing audits to verify compliance with GMP, GLP, and GDP standards.
5. What are the future supply chain trends for drugs like Zydelig?
Increasing localization, automation, sustainable manufacturing practices, and regional supply hubs aim to enhance resilience, reduce costs, and ensure regulatory compliance in the global supply of oncology drugs.
References
[1] Gilead Sciences Official Product Information, 2022.
[2] U.S. FDA Drug Approvals and Manufacturing Standards, 2022.
[3] Pharmaceutical Supply Chain Insights, 2023.
[4] International Council for Harmonisation (ICH) Guidelines.
[5] Industry Reports on API Manufacturing and Regulatory Standards, 2022.
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