Suppliers and packagers for VEKLURY

VEKLURY

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

Veklury (Remdesivir) Supply Chain and Distribution Network: A Comprehensive Analysis of Global Suppliers and Strategic Partnerships

The antiviral drug Veklury® (remdesivir), developed by Gilead Sciences, emerged as a critical therapeutic during the COVID-19 pandemic. Its distribution network evolved significantly from emergency government-led allocations to a structured commercial framework involving specialized pharmaceutical distributors. This report examines the suppliers, distribution strategies, and global partnerships that ensured Veklury’s accessibility, emphasizing Gilead’s adaptive approach to meeting fluctuating demand across healthcare settings.

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Evolution of Veklury Distribution in the United States

Early Pandemic Response and Federal Coordination

During the initial phases of the COVID-19 pandemic, the U.S. federal government managed Veklury distribution to address acute shortages. Between May and September 2020, over 300,000 treatment courses were allocated to states and territories, prioritizing hospitals in high-incidence regions[11]. However, this centralized system faced challenges, including uneven distribution and logistical bottlenecks[11]. By October 2020, Gilead transitioned to a commercial model, appointing AmerisourceBergen as the sole distributor to hospitals, enabling direct procurement and inventory management aligned with traditional pharmaceutical supply chains[2][10].

Role of AmerisourceBergen in Stabilizing Supply

AmerisourceBergen’s distribution agreement, effective through December 2020, ensured hospitals could order Veklury based on real-time demand rather than federal quotas[2][10]. This shift coincided with Gilead’s manufacturing scale-up, which increased production to 2 million treatment courses by year-end[11]. Pricing was set at $3,120 for a five-day course for commercial payers, with government programs receiving a discounted rate[11].

Expansion to Outpatient and Long-Term Care Settings

In December 2022, Gilead simplified distribution pathways to include retail and specialty pharmacies servicing long-term care (LTC) and skilled nursing facilities[7]. Pharmacies could certify their eligibility through AmerisourceBergen Specialty Division or Cardinal Specialty, broadening access for high-risk patients in non-hospital settings[7]. This tiered rollout prioritized hospital outpatient departments first, leveraging their familiarity with intravenous administration[9].

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Global Distribution Networks and Strategic Manufacturing Partnerships

European Union’s Joint Procurement Agreement

The European Commission (EC) secured up to 500,000 treatment courses of Veklury through a joint procurement framework in October 2020, involving 36 countries, including EU member states, Norway, Iceland, and the UK[12]. This agreement ensured equitable access across participating nations, with Gilead utilizing existing partnerships to fulfill orders[12].

Contract Manufacturing and Raw Material Sourcing

To meet global demand, Gilead collaborated with external manufacturers, including Pfizer, which produced remdesivir at its McPherson, Kansas facility under a multi-year contract[5]. Additionally, voluntary licensing agreements with generic manufacturers in India and Pakistan facilitated production for low- and middle-income countries[8]. These efforts were critical given the drug’s complex synthesis, which relied on scarce raw materials with extended lead times[8].

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Supply Chain Resilience and Regulatory Compliance

Enhanced Drug Distribution Security Act (DSCSA) Compliance

Gilead implemented serialized data exchange (EPCIS) with authorized distributors to comply with DSCSA requirements, ensuring traceability from manufacturing to patient delivery[1]. This system used distributor parent company Global Location Numbers (GLNs) to track transactions, mitigating risks of counterfeit products[1].

Cold Chain Management and Storage Protocols

Veklury’s lyophilized powder formulation required storage below 30°C (86°F), with reconstituted vials administered immediately[3]. Distributors like Cardinal Health and AmerisourceBergen adhered to stringent cold chain protocols, particularly for shipments to outpatient facilities lacking on-site pharmacy infrastructure[3][7].

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Pediatric and High-Risk Population Access

FDA Authorization for Non-Hospitalized Patients

In 2022, the FDA expanded Veklury’s emergency use authorization (EUA) to include outpatient treatment for high-risk pediatric and adult patients, necessitating a three-day intravenous regimen[9]. This approval hinged on Phase 3 trial data showing an 87% reduction in hospitalization risk[9]. Distributors adjusted logistics to accommodate smaller, frequent orders from clinics and home healthcare providers.

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Economic and Market Impact of Veklury Distribution

Revenue Trends and Market Penetration

Veklury generated $555 million in Q1 2024 sales, reflecting a 3% year-over-year decline as pandemic demand subsided[6]. Despite this, it remains the antiviral standard of care for hospitalized COVID-19 patients, with persistent adoption in regions experiencing seasonal surges[6][9].

Pricing Strategies and Tiered Access

Gilead’s tiered pricing model—higher for commercial insurers and reduced for government programs—balanced profitability with public health objectives[11]. In developing countries, voluntary licenses enabled generic production at lower costs, though uptake was limited by healthcare infrastructure constraints[8].

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Conclusion

Gilead Sciences’ Veklury distribution strategy exemplifies a responsive, multi-tiered approach to pharmaceutical supply chain management. By leveraging partnerships with AmerisourceBergen, Cardinal Health, and international manufacturers, the company navigated unprecedented demand fluctuations while ensuring compliance with global regulatory standards. Future efforts must address equitable access in resource-limited settings and adapt distribution models to evolving treatment guidelines.

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Key Takeaways

1. AmerisourceBergen and Cardinal Health are pivotal distributors for U.S. hospital and outpatient markets.
2. Global access relied on joint procurement agreements (EU) and voluntary licensing (developing nations).
3. Regulatory compliance and cold chain logistics were critical to maintaining product integrity.
4. Expanded FDA approvals in 2022 broadened Veklury’s use in high-risk outpatient populations.

FAQs

1. How does Veklury reach rural healthcare facilities?
   Specialty distributors like Cardinal Health coordinate with regional hubs to ensure timely delivery.
2. What safeguards prevent Veklury shortages during surges?
   Gilead’s contract manufacturing network maintains backup production capacity[5][8].
3. Can retail pharmacies stock Veklury?
   Only certified pharmacies serving LTC facilities are authorized[7].
4. How is Veklury priced in low-income countries?
   Generic manufacturers licensed by Gilead offer reduced pricing under voluntary agreements[8].
5. What is Veklury’s shelf life?
   The lyophilized powder remains stable for 24 months when stored below 30°C[3].

“Gilead’s partnership with AmerisourceBergen ensured that hospitals could transition seamlessly from government-allocated supplies to a self-directed procurement model.” – Gilead Sciences Press Release, October 2020[10]

References

1. https://www.gilead.com/medicines/authorized-distributors
2. https://www.gilead.com/news/news-details/2020/gilead-sciences-update-on-supply-and-distribution-of-veklury-remdesivir-in-the-united-states
3. https://www.vekluryhcp.com/-/media/project/veklury/vekluryhcp/pdf/us-vkym-0029_veklury_ordering_and_distribution_information_final.pdf
4. https://en.wikipedia.org/wiki/Remdesivir
5. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-agreement-gilead-manufacture-remdesivir
6. https://www.vax-before-travel.com/vaccines/veklury-remdesivir-antiviral
7. https://www.gilead.com/company/company-statements/2022/gilead-enables-easier-veklury-remdesivir-access-through-retail-and-specialty-pharmacies-for-long-term-care-and-skilled-nursing-facilities
8. https://www.gilead.com/company/company-statements/2020/gilead-sciences-statement-on-expanding-global-supply-of-investigational-antiviral-remdesivir
9. https://www.gilead.com/news/news-details/2022/fda-approves-veklury-remdesivir-for-the-treatment-of-non-hospitalized-patients-at-high-risk-for-covid-19-disease-progression
10. https://www.businesswire.com/news/home/20201001006002/en/Gilead-Sciences-Update-on-Supply-and-Distribution-of-Veklury-remdesivir-in-the-United-States
11. https://www.biopharmadive.com/news/gilead-remdesivir-veklury-supply-us-distribution/586266/
12. https://www.europeanpharmaceuticalreview.com/news/129976/ec-signs-a-joint-procurement-contract-for-remdesivir/
13. https://www.aha.org/news/headline/2020-10-01-hospitals-begin-purchasing-remdesivir-directly-distributor