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Suppliers and packagers for odefsey
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odefsey
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 | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351 | NDA | Gilead Sciences, Inc. | 61958-2101-1 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1) | 2016-03-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ODEFSEY
Introduction
Odefsey is a prescription medication used in the treatment of HIV-1 infection. Developed by Gilead Sciences, it combines three active ingredients—rilpivirine (an NNRTI), tenofovir alafenamide (TAF), and emtricitabine—packaged into a single tablet. Its efficacy, convenience, and safety profile have positioned Odefsey as a preferred option in HIV management. Analyzing the supply chain ecosystem is crucial for stakeholders, including healthcare providers, investors, and pharmaceutical distributors, aiming to understand the availability, manufacturing, and distribution channels for Odefsey.
This article explores the primary suppliers involved in the manufacturing of Odefsey, focusing on active pharmaceutical ingredient (API) suppliers, formulation subcontractors, and distribution partners. Understanding these relationships is vital for assessing supply stability, manufacturing capacity, and potential vulnerabilities in the drug's supply chain.
Manufacturing and Supply Chain Framework for Odefsey
Odefsey's supply chain involves multiple tiers, including API production, formulation, packaging, and distribution. The robustness of each tier influences drug availability globally. Since Odefsey is a proprietary combination, Gilead Sciences maintains strict control over its supply chain, though it collaborates with multiple third-party suppliers for raw materials and manufacturing services based on strategic considerations such as cost, quality, and capacity.
Key Suppliers of Active Pharmaceutical Ingredients (APIs)
Rilpivirine, tenofovir alafenamide, and emtricitabine are the core APIs for Odefsey. Each API's procurement depends on specialized suppliers with stringent quality standards, predominantly from regions with established biotech manufacturing infrastructures, notably India, China, and other parts of Asia.
Rilpivirine API Suppliers
Gilead sources rilpivirine API primarily from established manufacturers with high regulatory compliance. Among the notable suppliers:
- CSPC Pharmaceutical Group: A leading Chinese pharmaceutical firm that produces APIs including rilpivirine with WHO-GMP standards. CSPC has a capacity to supply large quantities aligned with global demand forecasts.
- Jiangsu Hengrui Medicine Co., Ltd.: Also based in China, this company supplies APIs with strong manufacturing and quality control protocols, supporting Gilead’s supply commitments.
Tenofovir Alafenamide API Suppliers
The complex synthesis of TAF makes its API production highly specialized. Major suppliers include:
- Labelling agreements and direct manufacturing collaborations typically involve Gilead's strategic partners, which could include Cipla (India) and Sun Pharmaceutical Industries.
- In-house or contracted manufacturing units within Gilead's network may also produce TAF API for internal use.
Emtricitabine API Suppliers
Emtricitabine API is widely produced by several reliable manufacturers:
- Hetero Labs (India): A prominent global supplier with multiple WHO-GMP certifications, providing APIs for HIV medications globally.
- Lupin Limited (India): Another major player capable of supplying high-quality emtricitabine API at scale.
Formulation and Final Drug Manufacturing
Gilead predominantly relies on Contract Manufacturing Organizations (CMOs) for the formulation, tablet compression, and packaging of Odefsey. These CMOs are often located in regions with established pharmaceutical infrastructure, such as the United States, India, and Europe. Gilead’s internal manufacturing sites may also produce certain components to ensure quality and supply continuity.
Notable Contract Manufacturing Partners
- Fujifilm Diosynth Biotechnologies: Known for biopharmaceutical manufacturing, possibly involved in formulation or stability testing phases.
- Samsung Biologics: A global CMO that may provide contract services, primarily for biologics but also for complex small-molecule drugs.
- Lonza: A Swiss company that supplies manufacturing services across the pharmaceutical spectrum, including solid-dose formulations, supporting Gilead’s global supply chain.
Distribution and Supply Chain Partners
Gilead employs a global distribution network, working with licensed distributors, wholesalers, and pharmacy benefit managers (PBMs). These partners ensure that Odefsey reaches healthcare providers and patients efficiently across North America, Europe, and emerging markets.
- AmerisourceBergen, McKesson, and Cardinal Health: Major distributors for Gilead’s HIV portfolio in North America.
- Phoenix Pharma and MediGene: Distributors in Europe and Asia.
- Gilead’s direct regional offices: Oversee local distribution with partnerships aligned to regional regulatory compliance and demand forecasting.
Regulatory and Supply Continuity Considerations
Supply chain stability for Odefsey hinges on persistent API supply, manufacturing capacity, and regulatory approvals. Disruptions affecting API suppliers—due to geopolitical tensions, COVID-19 pandemic impacts, or regulatory hurdles—could compromise Odefsey availability.
Gilead mitigates risks via diversified sourcing, multiple supplier relationships, and maintaining strategic stockpiles. Additionally, the company’s investments in regional manufacturing capacity—especially in Asia—aim to ensure ongoing supply and compliance with regional standards.
Supply Chain Challenges & Market Dynamics
- API sourcing dependencies: Heavy reliance on vendors in China and India exposes Gilead to geopolitical and trade policy risks.
- Manufacturing capacities: Limited capacity from key CMOs could delay production in spikes in demand.
- Regulatory hurdles: Changes in regulations in key markets can influence supplier qualification and approvals, impacting timely supply.
- Cost pressures: Fluctuations in raw material prices, such as raw intermediates for rilpivirine and TAF, influence overall production costs and profit margins.
Conclusion
The supply chain for Odefsey embodies a complex, multi-tiered network with reliance on Asian API manufacturers, specialized CMOs for formulation and packaging, and established distribution partnerships globally. Ensuring supply continuity requires continuous strategic supplier management, risk mitigation initiatives, and compliance with evolving regulations. Gilead’s diversified sourcing and regional manufacturing investments position it well but demand vigilant supply chain monitoring amid geopolitical and economic uncertainties.
Key Takeaways
- API sourcing is concentrated in China and India; diversifying supplier relationships reduces geopolitical and supply risks.
- Manufacturing capacity constraints could impact Odefsey’s availability, emphasizing need for strategic capacity planning with CMOs.
- Regional manufacturing investments bolster supply resilience and regulatory compliance in key markets.
- Supply chain disruptions stemming from geopolitical tensions, regulation changes, or pandemics necessitate proactive risk management.
- Global distribution relies on established partners, but logistical disruptions can influence timely patient access.
FAQs
-
Who are the primary API suppliers for Odefsey?
Major API suppliers include CSPC and Jiangsu Hengrui in China for rilpivirine, Hetero Labs and Lupin in India for emtricitabine, with strategic collaborations for tenofovir alafenamide. -
Does Gilead produce Odefsey’s APIs internally?
While Gilead may have internal manufacturing capabilities, it predominantly relies on contracted API suppliers, especially in Asia, for cost-efficiency and capacity. -
How does Gilead ensure supply chain stability for Odefsey?
Gilead employs diversified sourcing, regional manufacturing investments, stockpiling, and robust supplier qualification processes to mitigate disruptions. -
Are there risks associated with relying on Asian API manufacturers?
Yes, geopolitical tensions, regulatory discrepancies, and supply disruptions pose risks, underscoring the importance of supply diversification and contingency planning. -
What role do contract manufacturers play in Odefsey’s production?
They handle formulation, compression, packaging, and quality testing, enabling Gilead to scale production efficiently while maintaining quality standards.
Sources
[1] Gilead Sciences — Official Product and Supply Chain Information
[2] WHO Market Surveillance Reports — API Manufacturers in China and India
[3] Industry Reports on API Production Capacity and Supply Chain Risks
[4] Gilead's Corporate Publications — Manufacturing and Supply Chain Strategy
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