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Suppliers and packagers for VEKLURY
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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 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VEKLURY
Introduction
VEKLURY (remdesivir) has established itself as a crucial antiviral medication, especially highlighted during the COVID-19 pandemic for its efficacy against severe cases. Originally developed by Gilead Sciences, remdesivir has become widely used across global healthcare systems. The dynamic landscape of pharmaceutical supply chains and the criticality of maintaining consistent drug availability have intensified focus on the key suppliers involved in the manufacturing and distribution of VEKLURY.
This analysis explores the major suppliers of VEKLURY, examining their roles in the supply chain, manufacturing capacities, and recent developments. Understanding these suppliers offers pharmaceutical companies, healthcare policymakers, and investors essential insights into the drug's market stability and risks associated with production bottlenecks or geopolitical challenges.
Gilead Sciences: The Original Innovator and Primary Supplier
Manufacturing and Distribution
Gilead Sciences, based in Foster City, California, is the patent holder and primary manufacturer of remdesivir, marketed as VEKLURY. Its integrated supply chain incorporates multiple manufacturing sites spanning North America, Asia, and Europe. Gilead has invested heavily in scaling up production since the drug's emergency authorization in 2020, aiming to meet global demand.
Supply Chain Expansion and Collaborations
Gilead's strategy involves strategic partnerships to bolster manufacturing capacity. Notably, the company has engaged contract manufacturing organizations (CMOs) to supplement in-house production, ensuring a steady supply for hospitals and governments globally. These collaborations have helped Gilead escalate production from initial supply volumes to multi-million courses annually (Gilead, 2022).
Challenges and Risks
Despite robust manufacturing networks, Gilead faces potential risks related to raw material shortages, particularly for key intermediates. Geopolitical tensions, export restrictions, and pandemic-related disruptions could impact supply continuity.
Contract Manufacturing Organizations (CMOs)**
Key CMO Partners
Gilead relies on several CMOs to supplement its in-house manufacturing. Prominent among these are:
- Fujifilm Diosynth Biotechnologies (Fujifilm DBT), with facilities in the U.S. and the UK, specializes in advanced biopharmaceutical manufacturing (Fujifilm, 2021).
- Latvian pharmaceutical firm, Grindex, has supplied raw materials and intermediates during peak demand periods.
- Siegfried, based in Switzerland, has provided custom synthesis and fill-finish operations.
Role and Capacity
By outsourcing certain manufacturing steps—such as final formulation, fill-finish, and active pharmaceutical ingredient (API) synthesis—Gilead has diversified its production risk. These CMOs have expanded their capacities in line with Gilead's demand forecasts, enabling rapid scale-up during the pandemic.
Limitations
Dependence on CMOs introduces complexities related to quality control, regulatory approvals, and supply chain transparency. Disruptions at any partner can ripple through to availability.
Raw Material and API Suppliers
Active Pharmaceutical Ingredient (API) Production
Remdesivir's API production involves complex chemical synthesis requiring specialized raw materials and intermediates. Major API suppliers include:
- Hovione, with plants in Portugal, supplies key intermediates for remdesivir.
- Mitsubishi Gas Chemical, involved in raw material provision.
- Chanelle Pharmaceuticals, a contracted manufacturer for certain intermediates.
Raw Material Sourcing Challenges
Global shortages of key raw materials, exacerbated by trade restrictions and pandemic-related logistics issues, could threaten API supply. For example, the synthesis of remdesivir requires specific chlorinated compounds often produced in limited facilities.
Geopolitical Concerns
Supply chain vulnerabilities are intensified in regions with geopolitical instability, such as trade tensions between the U.S. and China, which could impact raw material access.
Distribution and Logistics
Global Distribution Networks
Gilead partners with major logistics firms like DHL and FedEx to distribute VEKLURY, ensuring compliance with storage requirements—particularly cold chain logistics in certain regions.
Regulatory and Export Considerations
Supply chain efficiency hinges on navigating regulatory landscapes across jurisdictions. Delays may occur due to differing approval pathways, import restrictions, or customs procedures.
Impact of Pandemic on Logistics
The COVID-19 pandemic significantly disrupted global logistics, leading to delays in delivery and stock shortages. Ongoing resilience measures include regional warehouses and diversified distribution channels.
Emerging Suppliers and Regional Production
Local Manufacturing Initiatives
Several countries have initiated local production efforts to mitigate reliance on external suppliers. For instance:
- India’s Biocon and Cipla are exploring generic manufacturing under licensing agreements.
- The African Union is seeking technology transfer initiatives to produce remdesivir locally.
Technology Transfer and Licensing
Gilead has entered licensing agreements with manufacturers in India and Egypt to produce low-cost generics, expanding access but also diversifying supply sources (Gilead, 2021).
Impacts on Global Supply
These regional efforts aim to improve supply security, especially in low- and middle-income countries, aligning with global health equity goals.
Regulatory Environment and Approval
Manufacturers must adhere to strict regulatory standards. Regulatory bodies like the FDA, EMA, and WHO impose manufacturing and quality controls that influence supply chain dynamics. Any regulatory setbacks at key manufacturing sites can hinder production timelines.
Future Outlook and Supply Chain Optimization
The supply chain for VEKLURY is expected to evolve with ongoing demand. Gilead and partners are investing in advanced manufacturing technologies, process innovations, and regional collaborations to enhance capacity and resilience. Supply chain diversification remains a priority to mitigate geopolitical and logistical risks.
Key Takeaways
- Gilead Sciences remains the primary supplier of VEKLURY, leveraging global manufacturing and outsourcing to expand capacity.
- Contract manufacturing organizations play a vital role but introduce dependencies that could impact supply.
- Raw material and API suppliers are concentrated in specific regions, posing risks related to geopolitical conflict and logistic disruptions.
- Distribution networks are complex, requiring robust logistics and regulatory navigation.
- Regional licensing and local manufacturing initiatives are crucial to increasing access, especially in low-income markets.
- Supply chain resilience depends on diversification, technological innovation, and global collaboration initiatives.
FAQs
1. Who is the primary manufacturer of VEKLURY (remdesivir)?
Gilead Sciences is the original patent holder and primary manufacturer of VEKLURY, utilizing a global network of in-house facilities and contract manufacturing partners.
2. What are the main risks to the supply chain of remdesivir?
Risks include raw material shortages, dependency on third-party manufacturing, geopolitical tensions, trade restrictions, and logistical disruptions caused by the pandemic.
3. Are there regional suppliers producing generic versions of remdesivir?
Yes, licensing agreements with firms in India and Egypt facilitate generic production, aiming to improve access in low- and middle-income countries.
4. How do manufacturing collaborations impact the supply of VEKLURY?
Collaborations with CMOs allow capacity expansion but introduce dependencies that could cause delays if issues arise at partner sites.
5. How is the supply chain for VEKLURY expected to evolve?
Focus is on technological advancements, regional manufacturing, licensing, and diversified sourcing to ensure supply stability amid rising global demand.
References
[1] Gilead Sciences. (2022). Remdesivir manufacturing and supply chain updates.
[2] Fujifilm Diosynth Biotechnologies. (2021). Partnerships for biopharmaceuticals.
[3] Gilead Sciences. (2021). Global licensing and regional manufacturing initiatives.
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