Suppliers and packagers for VIREAD

VIREAD

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	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577	NDA	Gilead Sciences, Inc.	61958-0403-1	1 BOTTLE, PLASTIC in 1 CARTON (61958-0403-1) / 60 g in 1 BOTTLE, PLASTIC	2012-01-18
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356	NDA	Gilead Sciences, Inc.	61958-0401-1	30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0401-1)	2001-10-26
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356	NDA	Gilead Sciences, Inc.	61958-0404-1	30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0404-1)	2012-01-18

Suppliers for the Pharmaceutical Drug: VIREAD

Last updated: August 2, 2025

Introduction

VIREAD (tenofovir disoproxil fumarate) is a widely prescribed antiviral medication primarily used to treat human immunodeficiency virus (HIV) infection and chronic hepatitis B virus (HBV) infection. Manufactured and marketed by Gilead Sciences, VIREAD's global supply relies on a complex network of suppliers involved across the manufacturing, formulation, and distribution stages. This article provides a comprehensive overview of key suppliers associated with VIREAD, analyzing their roles, geographic distribution, and the implications for supply chain resilience and market dynamics.

Manufacturing and Active Pharmaceutical Ingredient (API) Suppliers

At the core of VIREAD's supply chain are the suppliers of the active pharmaceutical ingredient (API), tenofovir disoproxil fumarate. API synthesis involves multiple specialized chemical processes that demand rigorous quality controls to comply with regulatory standards.

Gilead Sciences' In-House Production

Gilead maintains significant control over the production of tenofovir disoproxil fumarate, with proprietary manufacturing processes primarily based in the United States and Ireland. These facilities are accredited by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), ensuring compliance with Good Manufacturing Practice (GMP) standards.

External API Suppliers

Despite Gilead's significant in-house manufacturing capacity, external suppliers supply raw materials and intermediates, particularly for cost maintenance and supply diversification:

• Thermo Fisher Scientific: Provides chemical intermediates used in API synthesis, including phosphate donors and other key reagents.
• Hovione: Supplies development and manufacturing services for chemical intermediates and process optimization.

Challenges in API Supply

Reliance on external suppliers exposes Gilead to risks related to geopolitical issues, manufacturing disruptions, and regulatory hurdles. The complexity of API synthesis for tenofovir, involving multiple steps and high purity requirements, limits the number of qualified suppliers globally.

Formulation and Finished Product Suppliers

Post-API manufacturing, the production of finished VIREAD tablets involves formulation, compression, and packaging.

Contract Manufacturing Organizations (CMOs)

Gilead employs CMOs for large-scale formulation and packaging operations:

• Famar (Greece): A primary contract manufacturer for VIREAD, handling formulation and packaging processes.
• Jubilant HollisterStier (United States): Provides secondary packaging services and stability testing.

Distribution and Supply Chain Logistics

Distribution of VIREAD spans multiple regions, necessitating a robust logistics network. Distribution partners include:

• McKesson Corporation (United States): One of the largest distributors of pharmaceuticals, including VIREAD.
• DAIICHI SANKYO (Japan): Handles distribution within the Japanese market.
• EMC Corporation (Europe): Supplies European markets through regional logistics hubs.

Generic Suppliers and Market Competition

While Gilead predominantly controls VIREAD's production, generic manufacturers have entered markets where patent protections have expired or where patents are challenged.

Generic API Producers

• Hetero Drugs (India): Known to produce generic versions of tenofovir disoproxil fumarate.
• Mylan (now part of Viatris): Offers generic tenofovir formulations.

Implications of Supplier Dynamics

The presence of generic suppliers influences the pricing, market share, and accessibility of VIREAD worldwide. Patent expirations and legal challenges impact the strategic sourcing decisions by Gilead and generic manufacturers alike.

Supply Chain Risks and Mitigation Strategies

Dependence on specific suppliers introduces vulnerabilities, including supply shortages and Price volatility. Gilead mitigates these risks by maintaining diversified supplier relationships, investing in manufacturing plant redundancies, and engaging in long-term supply agreements.

Emerging Trends and Future Outlook

The continued evolution of global supply chains, driven by regulatory reforms and technological innovations, can alter the landscape of VIREAD suppliers. Advances in API synthesis, such as continuous manufacturing, could streamline supply and reduce reliance on limited suppliers.

Conclusion

VIREAD's supply chain exemplifies the complexities inherent in manufacturing essential antiviral medications, integrating in-house production with external supplier networks. Ensuring supply continuity mandates rigorous supplier qualification processes, diversified sourcing, and active risk management. As market dynamics evolve, stakeholders must stay abreast of supplier developments and regulatory shifts influencing supply stability.

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Key Takeaways

• Gilead primarily controls VIREAD's API production but relies on external suppliers for raw materials and intermediates.
• Major contract manufacturers like Famar play critical roles in formulation and packaging.
• Geographic diversification of suppliers enhances supply chain resilience, yet risks persist due to regulatory, geopolitical, and technical factors.
• Patent expirations open opportunities for generic API suppliers, influencing prices and accessibility.
• Proactive risk mitigation strategies are essential for uninterrupted global availability of VIREAD.

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FAQs

1. Who are the primary suppliers of the tenofovir disoproxil fumarate API for VIREAD?
   Gilead largely produces the API in-house but sources certain raw materials from companies such as Thermo Fisher Scientific and Hovione. External API producers like Hetero and Mylan supply generics in other markets.

2. Are there alternative suppliers for VIREAD in case of supply disruptions?
   While Gilead maintains diversified relationships, the specialized nature of API synthesis limits the number of qualified suppliers. The generics market provides alternative sources, but quality and regulatory considerations influence acceptance.

3. How does patent expiry impact the supply chain of VIREAD?
   Patent expiry allows generic manufacturers to produce tenofovir disoproxil fumarate, increasing supply options, reducing prices, and expanding access. It also introduces competition that can influence Gilead’s sourcing strategies.

4. What role do contract manufacturing organizations play in VIREAD’s production?
   CMOs like Famar handle formulation, tablet compression, and packaging, allowing Gilead to scale production efficiently and access specialized manufacturing capacities.

5. What are the main risks facing VIREAD's supply chain?
   Risks include dependence on limited API suppliers, geopolitical issues, regulatory hurdles, manufacturing disruptions, and patent litigation. Diversification and strategic partnerships are vital in mitigation.

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References

1. Gilead Sciences. (2022). VIREAD (tenofovir disoproxil fumarate) Prescribing Information.
2. U.S. Food and Drug Administration. (2021). Approved Drug Products with Therapeutic Equivalence Evaluations.
3. European Medicines Agency. (2022). Human medicines: Marketing authorisations.
4. MarketWatch. (2023). Global Tenofovir API Market Report.
5. WHO. (2020). Global HIV/AIDS statistics and treatment access.