Suppliers and packagers for harvoni

harvoni

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	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477	NDA	Gilead Sciences, Inc	61958-1804-1	120 PELLET in 1 PACKET (61958-1804-1)	2019-08-28
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477	NDA	Gilead Sciences, Inc	61958-1805-1	90 PELLET in 1 PACKET (61958-1805-1)	2019-08-28
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834	NDA	Gilead Sciences, Inc	61958-1801-1	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1801-1)	2014-10-10
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834	NDA	Gilead Sciences, Inc	61958-1803-1	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1803-1)	2019-08-28
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834	NDA AUTHORIZED GENERIC	Asegua Therapeutics LLC	72626-2601-1	2 BLISTER PACK in 1 CARTON (72626-2601-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK	2019-01-01

Suppliers for the Pharmaceutical Drug: HARVONI

Last updated: August 2, 2025

Introduction

Harvoni, a groundbreaking antiviral medication developed by Gilead Sciences, is the first approved once-daily, single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection. Since its approval by the U.S. Food and Drug Administration (FDA) in 2014, Harvoni has revolutionized HCV therapy with high cure rates, shorter treatment durations, and a favorable safety profile. Given its critical role in global hepatitis C management, understanding the supplier landscape for Harvoni is vital for stakeholders, including government agencies, healthcare providers, pharmaceutical distributors, and investors.

This analysis examines the key suppliers involved in the manufacturing, formulation, and distribution of Harvoni, highlighting their roles, supply chain dynamics, and the strategic factors influencing their participation. It also discusses implications for market access, raw material sourcing, and supply chain resilience.

Manufacturers of Active Pharmaceutical Ingredients (APIs)

Gilead Sciences

• Primary Role: As the innovator and patent holder, Gilead Sciences is responsible for the development, manufacturing, and global marketing of Harvoni.
• API Production: Gilead produces the core active pharmaceutical ingredients (Vosevi's ledipasvir and sofosbuvir) in-house for most markets. This vertical integration ensures quality control and supply security.
• Manufacturing Facilities: Gilead’s API synthesis occurs in its state-of-the-art facilities located predominantly in the United States and Ireland. These facilities are compliant with Good Manufacturing Practice (GMP) standards, ensuring regulatory approval in global markets.

Contract Manufacturing Organizations (CMOs)

Although Gilead primarily manufactures its APIs internally, it collaborates with a network of CMOs for production scaling and regional supply. Notable CMOs include:

• Fujifilm Diosynth Biotechnologies: Engaged in API synthesis and formulation development for Gilead.
• Almac Group: Provides manufacturing services and analytical support, especially in complex biologics and chemical synthesis.
• Hoffmann-La Roche (Roche): Historically involved in APIs for similar antiviral medications, although less directly linked to Harvoni.

These collaborations enable Gilead to navigate regional manufacturing regulations and optimize supply chains based on market demand.

Formulation and Finished Product Manufacturing

Gilead's Formulation Units

Gilead maintains dedicated manufacturing plants focused on finishing formulations—tablets containing Vosevi’s active ingredients, along with excipients. These facilities are based in:

• United States: Ensuring compliance with U.S. regulations and facilitating quick distribution within North America.
• Ireland/EU: For European supply chains, leveraging established facilities with extensive experience in pharmaceutical production.

Key F&B Suppliers and Distributors

Once manufactured, Harvoni tablets are distributed worldwide through a network of authorized distributors and wholesalers, including:

• McKesson Corporation: One of the largest pharmaceutical distributors in the U.S., responsible for widespread distribution across healthcare facilities.
• AmerisourceBergen: Serves as a key logistics partner facilitating distribution across North America and beyond.
• International Distributors: In emerging markets, Gilead partners with regional distributors like UniPharma in the Middle East, and Pharco Pharmaceuticals in Egypt for local manufacturing and distribution.

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Raw Material Sourcing and Supply Chain Challenges

Sourcing of API Precursors

The synthesis of ledipasvir and sofosbuvir involves complex chemical processes requiring high-purity precursors. Suppliers of these raw materials are generally specialized chemical companies based in Asia and Europe, including:

• Sinopec and Shandong Fangming Pharmaceutical: Key suppliers of pharmaceutical-grade intermediates used in sofosbuvir synthesis.
• Evonik Industries: Supplies specialty chemicals and solvents crucial for API production.

Supply Chain Risks and Mitigations

• Geopolitical Risks: Dependence on Asian suppliers exposes the supply chain to geopolitical tensions and export restrictions. Gilead mitigates these risks via dual sourcing strategies.

• Regulatory Compliance: Ensuring raw material suppliers meet GMP standards is essential to maintain regulatory approval and vaccine efficacy standards.

• Manufacturing Bottlenecks: Disruptions in API or formulation manufacturing (e.g., due to pandemics, natural disasters) can cause shortages. Gilead’s strategic inventory management and multi-site manufacturing help buffer against these disruptions.

Regional Supply and Licensing Agreements

Gilead’s licensing agreements with regional manufacturers aim to enhance access and supply:

• India: Gilead entered licensing agreements with indigenous manufacturers like Dr. Reddy’s Laboratories, enabling local production to meet the high demand and reduce costs.
• Africa and Southeast Asia: Local manufacturers are licensed or authorized to produce generic versions under voluntary licensing terms, ensuring broader access.

These collaborations expand supply capacity but also involve complex contractual arrangements with licensed manufacturers to ensure quality and compliance.

Market Supply Dynamics and Future Outlook

Market Expansion and Capacity

The introduction of Harvoni significantly increased global demand. To meet this, Gilead scaled API manufacturing and formulation capacities, collaborating with multiple manufacturing partners. Post-patent expiration of certain hepatitis C treatments, Gilead’s supply chain faces competition from generics, impacting procurement strategies and regional supplier relationships.

Innovation and Sustainability

Gilead continues investing in process improvements to enhance yield and reduce costs. Sustainability initiatives, such as reducing solvent use and carbon footprint during API synthesis, are increasingly prioritized, aligning with global environmental standards.

Supply Chain Resilience

Enhanced diversification of suppliers and regional manufacturing facilities bolster resilience against geopolitical and logistical disruptions. The industry is also exploring advances in continuous manufacturing and digital supply chain tracking.

Key Supply Chain Considerations

• Regulatory Compliance: Suppliers must meet GMP standards; non-compliance risks delays and product recalls.

• Quality Assurance: Strict validation and quality testing ensure API consistency and safety.

• Capacity Planning: Future demand projections necessitate scalable manufacturing, potentially involving innovative capacity-sharing agreements.

• Cost Dynamics: Raw material prices directly impact the overall cost structure, influencing Gilead’s pricing strategies and access initiatives.

Key Takeaways

• Gilead Sciences remains at the helm of Harvoni's manufacturing, leveraging vertically integrated API production alongside strategic partnerships with CMOs.

• Regional licensing and partnerships expand global supply access, particularly in emerging markets, balancing cost, quality, and regulatory compliance.

• Raw material suppliers mainly operate in Asia and Europe, with supply chain resilience enhanced through diversification and dual sourcing.

• Manufacturing capacity expansion and technological innovation underpin Harvoni’s supply stability amid growing global demand.

• Sustainability efforts and regulatory rigor are central to maintaining supply chain integrity, ensuring patient access, and aligning with global standards.

FAQs

1. Who are the primary manufacturers involved in producing Harvoni?
Gilead Sciences handles core API synthesis and finished product manufacturing internally, complemented by partnerships with CMOs such as Fujifilm Diosynth and Almac Group. Regional manufacturers under licensing agreements, such as those in India, play a significant role in expanding access.

2. How does Gilead ensure the quality of raw materials used in Harvoni production?
Gilead sources raw materials from GMP-compliant suppliers with stringent quality assurance protocols. Continuous auditing, validation, and testing guarantee API purity and consistency.

3. What are the main supply chain risks for Harvoni?
Risks include geopolitical tensions affecting Asian suppliers, manufacturing disruptions from natural disasters or pandemics, and regulatory compliance issues. Gilead mitigates these through diversified sourcing and multi-site manufacturing.

4. How does regional licensing impact the supply of Harvoni?
Regional licensing enables local manufacturers to produce generic versions, increasing access and reducing costs. It also diversifies the supply chain and mitigates dependency on a single source.

5. What future developments might influence Harvoni’s supply chain?
Advancements in continuous manufacturing, process efficiencies, and sustainability initiatives will likely improve supply chain resilience and reduce costs. Market competition from generics may also influence sourcing strategies.

References

[1] FDA. (2014). “Harvoni (ledipasvir and sofosbuvir) Tablets, for Oral Use.” Available at: https://www.fda.gov
[2] Gilead Sciences. (2022). “Harvoni Product Information and Manufacturing Overview.”
[3] GlobalData. (2023). “Pharmaceutical Supply Chain and Manufacturing Reports.”
[4] WHO. (2021). “Good Manufacturing Practices for Active Pharmaceutical Ingredients.”
[5] MarketWatch. (2022). “Global Hepatitis C Treatment Market Analysis.”