tenofovir alafenamide fumarate: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464	NDA	Gilead Sciences, Inc.	61958-2301-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2301-1)	2016-11-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Tenofovir Alafenamide Fumarate (TAF) is a vital antiretroviral agent in the treatment of HIV and hepatitis B virus (HBV) infections. Recognized for its improved safety profile over Tenofovir Disoproxil Fumarate (TDF), TAF has gained widespread adoption within global pharmaceutical markets. As demand increases, understanding the critical suppliers involved in TAF production becomes essential for stakeholders—including pharmaceutical companies, healthcare providers, and investment firms—aiming to ensure supply security, cost-effectiveness, and compliance with regulatory standards.

Overview of Tenofovir Alafenamide Fumarate Manufacturing

TAF is produced through complex chemical synthesis involving multiple steps that require advanced manufacturing facilities compliant with Good Manufacturing Practice (GMP) standards. The supplier landscape for TAF comprises globally recognized pharmaceutical CDMOs (Contract Development and Manufacturing Organizations), API (Active Pharmaceutical Ingredient) producers, and chemical intermediates suppliers.

Major Suppliers of TAF API

1. Gilead Sciences

Role & Market Position: Gilead Sciences is the originator of TAF, holding key patents and intellectual property rights. The company developed and licensed TAF formulations, producing its own API primarily for internal use and proprietary formulations.
Supply Chain Dynamics: Gilead's strategic control over TAF API positions it as a dominant supplier, especially in markets where patent protections are enforced rigorously.
Implication for Buyers: Market exclusivity gives Gilead a competitive advantage but can limit supply diversity for non-generic applications.

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview: Hengrui Medicine is a prominent Chinese pharmaceutical company entering the TAF market as a licensed producer and developer.
Manufacturing Capabilities: The company has invested heavily in GMP-compliant facilities capable of large-scale API synthesis.
Market Impact: Their entry increases regional supply options, especially in Asia, and may influence price competition.

3. Hetero Labs Limited (India)

Background: Hetero Labs is a significant Indian API manufacturer specializing in antiviral APIs, including nucleotide reverse transcriptase inhibitors.
Manufacturing Scope: They have developed TAF synthesis processes compliant with international standards.
Strategic Importance: Hetero’s TAF production offers more diversified supply sources for generic and branded pharmaceutical companies globally.

4. Mylan N.V. (now Viatris)

Supply Contributions: Mylan, now part of Viatris, has historically been involved in producing and distributing a wide range of antiretroviral APIs.
Market Role: Their manufacturing facilities in India and Europe are capable of producing TAF, making them notable players in increasing supply capacity.

5. Other Emerging Suppliers

Several smaller biotech firms and CDMOs in Asia and Europe are developing TAF manufacturing capabilities, attracted by its rising demand. Notably:

Cipla Limited (India): The company is developing TAF formulations and APIs, targeting the global markets.
CordenPharma (Germany): Offers specialized chemical synthesis services that could include TAF intermediates as demand grows.

Key Market Trends Affecting Supplier Selection

Patent Expirations: As patents for branded TAF formulations expire in key markets, generic manufacturers, especially in India and China, are ramping up API production.
Regulatory Approvals: Suppliers must hold GMP certification aligned with the target markets’ regulatory agencies (e.g., FDA, EMA, NMPA).
Supply Security: Diversification of suppliers mitigates risk against geopolitical disruptions, regulatory delays, and capacity constraints.
Cost Factors: Raw material sourcing, manufacturing efficiency, and economies of scale influence competitive pricing.

Regulatory and Quality Considerations

Suppliers must adhere to rigorous quality assurance standards and possess comprehensive regulatory documentation. Regulatory authorities inspect manufacturing facilities to ensure compliance, which directly impacts supply chain reliability:

FDA Inspection and Approval: For suppliers targeting U.S. markets.
EMA Certification: For European market access.
NMPA Certification: For Chinese market supplies.

Ensuring supplier compliance mitigates risk of product recalls, regulatory delays, and legal challenges.

Future Outlook and Emerging Suppliers

Amid increasing global demand, new players are entering the TAF supply chain:

Biotech Startups: Innovators focusing on novel synthesis methods.
Asian API Giants: Chinese and Indian manufacturers expanding capacities.
Partnerships & Licensing: Major pharmaceutical companies increasingly seek licensing agreements with regional manufacturers to expand supply, minimize costs, and meet local market needs.

Conclusion

The supply chain for Tenofovir Alafenamide Fumarate API is increasingly diversified, driven by patent expiries, regional market growth, and technological advancements in synthesis processes. Key suppliers include Gilead Sciences (patent holder), Jiangsu Hengrui, Hetero Labs, Viatris (Mylan), and emerging regional manufacturers in Asia. Ensuring supply stability involves evaluating supplier quality, regulatory compliance, capacity, and geopolitical factors. Strategic partnerships and ongoing innovation will shape the future landscape of TAF supply.

Key Takeaways

Market Leader: Gilead maintains a dominant API supply role but faces increasing competition as patents expire.
Regional Diversification: China and India are central in expanding TAF manufacturing, providing cost-competitive options.
Regulatory Vigilance: Suppliers must meet stringent quality standards to sustain market access.
Supply Risks: Dependency on limited suppliers poses risks; diversification is essential.
Growth Drivers: Rising HIV and HBV treatment demands continue to propel TAF production, inviting new entrants and capacity expansions.

FAQs

1. Who are the primary global suppliers of Tenofovir Alafenamide Fumarate API?
Major suppliers include Gilead Sciences, Jiangsu Hengrui Medicine, Hetero Labs Limited, and Viatris (formerly Mylan). Emerging regional manufacturers in China and India are also increasing their presence.

2. Are there generic versions of TAF available in the market?
Yes. Several Indian and Chinese manufacturers have developed generic TAF APIs following patent expirations or licensing agreements, expanding global access.

3. What regulatory requirements do TAF API suppliers need to meet?
Suppliers must adhere to GMP standards aligned with FDA, EMA, and NMPA regulations, including quality control, documentation, and facility inspections.

4. How does patent status impact API supplier choices?
Patent protections limit generic manufacturing; once patents expire, additional manufacturers can produce TAF, increasing supply options and reducing costs.

5. What future trends will influence TAF supply chains?
Continued patent expiries, regional manufacturing capacity growth, technological innovations, and strategic licensing will shape the evolving TAF supply landscape.

References

Gilead Sciences. "Tenofovir Alafenamide (TAF) Product Information." [Gilead official documentation]
Hetero Labs Limited. "Antiviral API Portfolio." [Company disclosures]
Jiangsu Hengrui Medicine Co. Ltd. "API Manufacturing Capabilities." [Company reports]
Viatris (formerly Mylan). "Global API Manufacturing Overview." [Corporate website]
Market analysis reports on antiretroviral API suppliers, 2022–2023.

Suppliers and packagers for generic pharmaceutical drug: tenofovir alafenamide fumarate