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	POWDER;INTRAVENOUS	214787	NDA	Gilead Sciences, Inc.	61958-2902-2	1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2902-2) / 20 mL in 1 VIAL, SINGLE-DOSE	2022-03-25
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
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787	NDA	Gilead Sciences, Inc.	61958-2902-2	1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2902-2) / 20 mL in 1 VIAL, SINGLE-DOSE	2022-03-25

Global Supply Chain and Key Suppliers of Remdesivir: A Comprehensive Analysis

The antiviral drug remdesivir, marketed under the brand name Veklury, emerged as one of the first treatments authorized for COVID-19 during the early stages of the pandemic. Developed by Gilead Sciences, its complex manufacturing requirements and global demand necessitated an expansive supply chain involving multinational pharmaceutical companies, generic manufacturers, and specialized contract producers. This report examines the key suppliers, licensing agreements, production challenges, and market dynamics shaping remdesivir’s availability worldwide.

---

Gilead Sciences: Originator and Primary Manufacturer

Development and Initial Production

Gilead Sciences invented remdesivir as a nucleotide analog, building on decades of antiviral research[3][10]. The drug’s initial production faced significant hurdles due to its intricate synthesis process, which involves 70 raw materials, reagents, and catalysts across 25 chemical steps[10]. Early batches required 9–12 months to produce, but process optimizations reduced this timeline to six months by April 2020[10]. Gilead’s facilities in Edmonton, Alberta, and La Verne, California, served as primary production hubs, with the company stockpiling 100 kg of the drug by February 2020[10].

Strategic Partnerships for Scale-Up

To meet surging demand, Gilead partnered with Pfizer Inc. in August 2020 for contract manufacturing at Pfizer’s McPherson, Kansas facility[1]. This agreement complemented Gilead’s existing network of external manufacturers, enabling broader distribution across the U.S. and Europe[1][6]. By October 2020, Gilead transitioned from government-led distribution to direct sales to U.S. hospitals, with AmerisourceBergen remaining the sole distributor[6].

---

Voluntary Licensing Agreements for Global Access

Terms and Geographic Scope

In May 2020, Gilead established non-exclusive voluntary licenses with five generic manufacturers: Cipla, Hetero Labs, Jubilant Lifesciences, Mylan, and Ferozsons Laboratories[4][7][9][11]. These agreements permitted production and distribution in 127 countries, primarily low- and middle-income nations, excluding the U.S. and much of Europe[8][11]. Licensees received technology transfers to accelerate production and retained pricing autonomy, with royalty-free terms until the WHO declared the end of the COVID-19 emergency or alternative treatments became available[4][8][11].

Impact on Supply in Critical Regions

India, a focal point of generic production, saw emergency approvals for Cipla and Hetero Drugs by June 2020[10]. During India’s devastating COVID-19 wave in April 2021, Gilead donated 450,000 vials of Veklury while supporting licensees in scaling batch sizes and onboarding local contract manufacturers[3]. This effort aimed to address acute shortages but highlighted persistent challenges in balancing global equity with commercial priorities[3][5].

---

Key Generic Suppliers and Manufacturing Networks

Licensed Generic Manufacturers

• Cipla Limited: Produced generic remdesivir under the brand name Cipremi, leveraging its extensive API manufacturing capabilities[2][9].
• Hetero Labs: Launched Covifor, contributing to India’s domestic supply and exports to Southeast Asia and Africa[2][10].
• Mylan N.V.: Developed a bioequivalent version using in-house API, targeting intravenous administration in lyophilized form[7][9].
• Jubilant Lifesciences: Scaled production through new facilities and contract partnerships, emphasizing cost efficiency[2][9].
• Ferozsons Laboratories: Focused on distribution in Pakistan and neighboring regions, addressing regional healthcare gaps[4][11].

API and Excipient Suppliers

Remdesivir’s synthesis relies on specialized active pharmaceutical ingredients (APIs) and stabilizers. Shandong Chenghui Shuangda Pharmaceutical and Dalian Richon Chem emerged as critical API suppliers, while Ligand Pharmaceuticals provided Captisol, a cyclodextrin-based excipient essential for drug stability[10][13]. Captisol demand surged due to its 30:1 ratio with remdesivir, prompting Ligand to expand annual production capacity to 500 metric tons[10].

---

Distribution Challenges and Market Dynamics

U.S. Government Stockpiling and Equity Concerns

In July 2020, the U.S. secured over 90% of Gilead’s global remdesivir supply through September, purchasing 500,000 treatment courses at $3,120 per patient[5][6]. This move drew criticism for exacerbating shortages in lower-income countries, where generic alternatives were not yet widely available[5][8]. Health systems in Europe and Asia faced delays, relying on strained donation programs and emergency imports[5][12].

Pricing and Affordability Debates

Gilead’s pricing strategy attracted scrutiny, with the Institute for Clinical and Economic Review (ICER) estimating a cost-based price range of $4,580–$5,080 per course[2]. However, tiered pricing for high-income ($3,120) and developing nations ($390) attempted to balance profitability with access[2][5]. Generic versions sold for as low as $60 per vial in India, though supply chain inefficiencies often inflated end-user costs[10][13].

---

Production Barriers and Regulatory Hurdles

Complex Manufacturing Workflows

Remdesivir’s production involves hazardous materials like trimethylsilyl cyanide and requires sterile, glass-lined reactors to prevent contamination[10]. These constraints limited rapid scale-up, with only 35% of licensed manufacturers achieving full operational capacity by late 2020[2][9].

Regulatory Fragmentation

While the FDA granted emergency use authorization in May 2020, regulatory divergences slowed global rollout. The European Medicines Agency (EMA) mandated additional stability testing for generic variants, delaying approvals in EU markets[7][9]. In contrast, India’s Drug Controller General fast-tracked approvals under emergency provisions, highlighting disparities in regulatory agility[10][13].

---

Future Outlook and Lessons Learned

Sustaining Global Equity Post-Pandemic

Gilead’s licensing model, while innovative, underscores the tension between patent protections and public health needs. The World Health Organization’s (WHO) mRNA vaccine hub initiative, inspired in part by remdesivir’s supply inequities, aims to decentralize production of critical medicines[3][8]. Future pandemics may require binding agreements to prevent high-income nations from monopolizing early supplies.

Technological and Collaborative Innovations

Advances in continuous manufacturing and modular reactor systems could simplify remdesivir synthesis, reducing dependency on single-source suppliers like Ligand Pharmaceuticals[10][13]. Open-source patent pools, akin to the Medicines Patent Pool for HIV drugs, might further democratize access during health crises[8][11].

---

Key Takeaways

1. Gilead Sciences retained control over remdesivir’s core patents but relied on partnerships with Pfizer, generic manufacturers, and API suppliers to meet demand[1][4][10].
2. Voluntary licensing agreements enabled rapid generic production in India and Pakistan but excluded many high-burden countries[8][11].
3. U.S. stockpiling highlighted systemic inequities in global drug distribution, prompting calls for reformed pandemic response frameworks[5][12].
4. Manufacturing complexity and regulatory fragmentation remain barriers to equitable access, necessitating technological and policy innovations[2][10].

---

FAQs

1. Which companies are licensed to produce generic remdesivir?
Cipla, Hetero Labs, Jubilant Lifesciences, Mylan, and Ferozsons Laboratories hold licenses for 127 countries[4][7][11].

2. How much does remdesivir cost per treatment course?
Prices range from $390 in developing nations to $3,120 in the U.S., with generics priced as low as $60 per vial[2][5][13].

3. What role did the U.S. government play in remdesivir distribution?
The U.S. purchased 90% of global supply from July–September 2020, diverting shipments from other regions[5][12].

4. What are the main production challenges for remdesivir?
Complex synthesis, hazardous materials, and dependency on specialized excipients like Captisol limit scalability[10][13].

5. How did India address its remdesivir shortage during the 2021 COVID-19 surge?
Gilead donated 450,000 vials and supported licensees in expanding production capacity through local contractors[3][10].

---

"The high-end pricing of remdesivir is expected to hinder the growth of the market." — The Business Research Company Market Report[2].

References

1. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-agreement-gilead-manufacture-remdesivir
2. https://www.thebusinessresearchcompany.com/report/remdesivir-global-market-report
3. https://www.gilead.com/news/news-details/2021/gilead-sciences-announces-steps-to-expand-availability-of-remdesivir-in-india
4. https://www.drugdiscoverytrends.com/gilead-licenses-remdesivir-production-to-5-generic-drugmakers/
5. https://www.businessinsider.com/us-buys-nearly-all-worlds-remdesivir-for-next-three-months-2020-7
6. https://www.fiercepharma.com/pharma/gilead-takes-back-remdesivir-distribution-after-drop-demand-confusing-government-allocation
7. https://www.pharmaceutical-technology.com/news/gilead-remdesivir-licensing-deals/
8. https://natap.org/2020/COVID/051320_01.htm
9. https://www.massdevice.com/gilead-licenses-remdesivir-production-to-5-generic-drugmakers/
10. https://en.wikipedia.org/wiki/Remdesivir
11. https://www.aa.com.tr/en/americas/covid-19-gilead-inks-deal-with-5-firms-for-remdesivir/1839322
12. https://whyy.org/articles/whos-getting-supplies-of-the-covid-drug-remdesivir-pharmacists-hospitals-want-to-know/
13. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/remdesivir