Suppliers and packagers for generic pharmaceutical drug: REMDESIVIR

REMDESIVIR

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	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787	NDA	Gilead Sciences, Inc.	61958-2901-2	1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2020-11-01
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787	NDA	Gilead Sciences, Inc.	61958-2901-2	1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2020-11-01

Suppliers for the Pharmaceutical Drug: REMDESIVIR

Last updated: July 29, 2025

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Introduction

Remdesivir (brand name Veklury) emerged as a pivotal antiviral for the treatment of COVID-19, especially during the early stages of the pandemic. As an antiviral nucleotide analogue prodrug, its production and supply chain are critical to global health efforts. Identifying key suppliers and understanding the ecosystem behind remdesivir's manufacturing is essential for stakeholders keen on ensuring steady access, assessing supply risks, and navigating regulatory hurdles.

Manufacturers and Original Development

Remdesivir was developed by Gilead Sciences, Inc., a biopharmaceutical company based in Foster City, California. Gilead not only pioneered the compound but also undertook the manufacturing and distribution logistics during the pandemic. Gilead's early commitment involved scaling production from pilot batches to large-scale manufacturing to meet global demand amid widespread emergency authorizations.

Key Contract Manufacturers

Gilead Collaborations

• Cipla Limited (India): Early licensed producer, Cipla has manufacturing capacity for remdesivir, primarily serving the Indian and emerging markets. Cipla's strategic partnership with Gilead enabled rapid local production to meet regional needs.

• Hetero Labs Limited (India): Included among Gilead's licensed manufacturers, Hetero developed substantial production capacity and has played a significant role in addressing supply shortages in India and Southeast Asia.

• Fujifilm Toyama Chemical (Japan): An early partner in the Japanese market, leveraging local manufacturing capabilities to supply remdesivir domestically and potentially export.

• Fujifilm Diosynth Biotechnologies (UK): Contract manufacturing organization (CMO) responsible for large-scale synthesis and formulation, offering clinical and commercial supply solutions.

• Fujifilm Diosynth's U.S. facilities: Engaged in process development and production, supporting Gilead’s global supply chain.

• Other Licensed Entities: Several regional manufacturers, including those in South Korea, Egypt, and Brazil, have obtained licensing rights for local production, often through Gilead or via technology transfer agreements.

Emerging Manufacturing Capabilities & Global Suppliers

In response to the pandemic, multiple countries accelerated licensure and direct manufacturing initiatives. Notably:

• Dr. Reddy’s Laboratories (India): Licensed to produce remdesivir, expanding supply in the Indian subcontinent and some other developing markets.

• Mylan (Now part of Viatris): Entered licensing agreements temporarily to support supply chains early in the pandemic.

• CordenPharma (Germany): A specialized CMO producing components of remdesivir, including API intermediates.

• Dr. Reddy’s and other regional APIs producers: Developed domestic API manufacturing capabilities, which reduces dependency on limited suppliers and mitigates risk of shortages.

Supply Chain and Raw Material Sources

The production of remdesivir involves complex chemical synthesis stages, including intermediates and active pharmaceutical ingredients (API). The API synthesis requires specialized raw materials, some of which are sourced from specific regions with chemical manufacturing clusters in China and India. The key raw materials are:

• Nucleoside analog precursors: Often produced in Asia, particularly China, due to established chemical manufacturing infrastructure.

• Intermediates for API synthesis: Sourced from multiple suppliers under strict quality controls.

The dependence on Asian suppliers introduces geopolitical and logistical considerations that can influence supply stability.

Regulatory Approvals and Licensing

The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for remdesivir in May 2020. Similar approvals or authorizations were granted in Europe, Asia, and Latin America, often conditional on manufacturers' ability to ensure supply.

Gilead's licensing agreements facilitated manufacturing scalability. These agreements, notably with Cipla, Hetero, and Dr. Reddy’s, allowed local production under license, critical for access in low- and middle-income countries.

Challenges in the Supply Chain

• Manufacturing complexity: The intricate multi-step synthesis process requires advanced facilities, limiting the number of capable producers.

• Raw material sourcing: dependency on Chinese and Indian chemical suppliers raises concerns over geopolitical risks and customs delays.

• Quality control: Ensuring consistent API quality across multiple manufacturers necessitates rigorous oversight and harmonized standards.

• Supply-demand mismatch: Early phases of the pandemic saw shortages, highlighting the necessity for scalable manufacturing and diversified supply sources.

Market Dynamics and Future Outlook

Gilead continues to expand its manufacturing footprint and licensing agreements to increase global availability. The company's strategic partnerships aim to meet ongoing demand, especially as remdesivir remains part of treatment protocols for COVID-19 and future viral outbreaks.

Additionally, the potential for third-party generic manufacturers in India and Egypt to produce remdesivir under licensing could further diversify supply sources, mitigate risks, and reduce costs.

Conclusion

The supply ecosystem for remdesivir involves a blend of original developers, licensed manufacturing partners globally, and raw material suppliers primarily situated in Asia. While Gilead Sciences remains the primary orchestrator of production, strategic collaborations with regional manufacturers have become essential for widespread access. The ongoing need for robust supply chains continues, especially considering the drug's importance in current and future pandemic preparedness.

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Key Takeaways

• Gilead Sciences led the development and initially controlled remdesivir's global supply chain, leveraging licensing agreements to expand manufacturing worldwide.
• Regional licensing partners such as Cipla, Hetero, and Dr. Reddy’s significantly increased local production, especially in India and emerging markets.
• Raw material sourcing from Asia, notably China and India, is critical and poses geopolitical and logistical risks.
• Manufacturing complexity limits the number of capable producers, emphasizing the importance of diversified, strategic licensing and supply agreements.
• Future supply stability depends on expanding manufacturing capacity, strengthening regional production, and securing raw material supply chains.

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FAQs

1. Which companies are the primary licensed manufacturers of remdesivir?
Principal licensed manufacturers include Gilead Sciences (original developer), Cipla, Hetero Labs, Dr. Reddy’s Laboratories, and Fujifilm Diosynth Biotechnologies, with additional regional licensees in various emerging markets.

2. What raw materials are critical in remdesivir production, and where are they sourced?
Key raw materials include specialized nucleoside precursors and intermediates, primarily sourced from Chinese and Indian chemical manufacturers due to established supply chains and cost advantages.

3. How have licensing agreements affected remdesivir's global supply?
Licensing agreements have significantly increased manufacturing capacity in India and other regions, improving access and reducing bottlenecks caused by limited API producers.

4. What are the main challenges faced in remdesivir supply chain management?
Challenges include manufacturing complexity, raw material sourcing dependencies, quality control across multiple manufacturers, and geopolitical risks affecting raw material importation.

5. What is the future outlook for remdesivir supply?
The future depends on expanding manufacturing capacity through licensing, local raw material production, and technological innovations to simplify synthesis processes, ensuring sustained supply amid ongoing COVID-19 management.

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References

1. Gilead Sciences. Veklury (remdesivir) prescribing information. 2021.
2. World Health Organization. Remdesivir for COVID-19: WHO solidarity trial. 2022.
3. Cipla Ltd. Remdesivir manufacturing and licensing updates. 2022.
4. Hetero Labs. Product portfolio and licensing agreements. 2022.
5. Dr. Reddy’s Laboratories. COVID-19 therapeutics manufacturing capacity. 2022.