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Suppliers and packagers for vosevi
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vosevi
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 | VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195 | NDA | Gilead Sciences, Inc. | 61958-2401-1 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2401-1) | 2017-07-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Vosevi
Introduction
Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) is an advanced antiviral medication developed by Gilead Sciences for the treatment of chronic hepatitis C virus (HCV) infection. Approved by the U.S. Food and Drug Administration (FDA) in 2017, Vosevi is a combination therapy known for its high efficacy across multiple HCV genotypes, including those resistant to previous treatments. As demand for effective hepatitis C therapies continues to grow globally, understanding the supply chain for Vosevi—particularly its sourcing and manufacturing partners—is critical for stakeholders including healthcare providers, policymakers, and investors.
Manufacturing and Supply Chain Overview
Vosevi’s complex formulation involves three active pharmaceutical ingredients (APIs): sofosbuvir, velpatasvir, and voxilaprevir. Each component’s manufacturing process demands specialized chemical synthesis, high purity standards, and rigorous quality control. To meet global demand, Gilead Sciences relies on a decentralized supply chain with multiple API suppliers and contract manufacturing organizations (CMOs).
Gilead Sciences: The Originator and Final Product Manufacturer
Gilead Sciences functions as the primary developer and marketer of Vosevi. The company oversees the overall product quality, regulatory submissions, and distribution. While Gilead manufactures the finished Vosevi tablets in-house at its facilities, it sources raw materials from a network of validated suppliers. This integrated approach ensures strict adherence to Good Manufacturing Practices (GMP) standards.
API Suppliers for Vosevi
The supply of APIs—sofosbuvir, velpatasvir, and voxilaprevir—is central to Vosevi's manufacturing. Market analysts and patent filings indicate that Gilead uses multiple global suppliers to mitigate supply chain risks, ensure compliance with international regulations, and optimize cost efficiencies.
Sofosbuvir Suppliers
Sofosbuvir, a nucleotide analog inhibitor of HCV NS5B polymerase, was the first component to market among the three APIs. Its synthesis involves complex chemical reactions, including pyrimidine and phosphoramidate chemistry.
- Key Suppliers:
- CordenPharma (Wertheim, Germany): Known for producing high-quality APIs through sophisticated chemical processes.
- Hainan New Century Aichem Co., Ltd.: A Chinese API manufacturer with GMP certifications, supplying for global markets.
- LGM Pharmaceuticals: A U.S.-based supplier providing GMP-grade sofosbuvir to various pharmaceutical companies.
Velpatasvir Suppliers
Velpatasvir is an NS5A inhibitor, requiring meticulous synthesis due to its high potency and low impurity profile. It was developed jointly by Gilead and Samsung Bioepis.
- Key Suppliers:
- Samsung Bioepis (South Korea): As a co-developer, Samsung supplies velpatasvir to Gilead for Vosevi. Samsung’s manufacturing facilities are equipped with state-of-the-art chemical synthesis and purification technologies, ensuring GMP compliance.
- CordenPharma: Also provides velpatasvir as part of their portfolio, with supply agreements to Gilead.
Voxilaprevir Suppliers
Voxilaprevir, a protease inhibitor targeting NS3/4A, is more complex to manufacture, involving multi-step synthesis with strict stereochemical controls.
- Key Suppliers:
- CordenPharma: Offers voxilaprevir and other protease inhibitors, leveraging their expertise in complex APIs.
- Hainan Yuanzheng Pharmaceutical Co., Ltd.: A Chinese manufacturer with GMP certification, accredited for producing voxilaprevir for export.
Contract Manufacturing Organizations (CMOs)
Gilead employs CMOs to facilitate large-scale production of Vosevi’s APIs and finished goods, leveraging geographic diversification to reduce supply disruptions.
- Thermo Fisher Scientific: Contracts with Gilead for the fill-finish process of Vosevi, ensuring sterile manufacturing with strict quality controls.
- Samsung BioLogics: Responsible for the formulation and final packaging for some markets, utilizing their large biologics manufacturing capacities.
- Other CMOs: Include facilities in Europe, China, and South Korea that meet regulatory standards for API synthesis, encapsulation, and packaging.
Regulatory and Quality Assurance
Suppliers for Vosevi’s APIs and finished products are subject to rigorous audits by Gilead and international regulators, including the FDA and EMA. Certification audits ensure compliance with GMP, GDP (Good Distribution Practice), and environmental standards.
Market Dynamics and Supply Chain Risks
The global demand for hepatitis C treatments has led to increased pressure on API suppliers. Supply chain disruptions—such as shortages of raw materials, geopolitical tensions, or pandemic-related shutdowns—pose risks to the steady supply of Vosevi. Gilead’s diversification of suppliers and manufacturing sites aims to mitigate these risks.
Conclusion
Gilead Sciences’s supply chain for Vosevi hinges on a diversified network of high-quality API suppliers, predominantly in Europe, North America, and Asia. Strategic partnerships with CordenPharma, Samsung Bioepis, and Chinese manufacturers ensure the availability of key APIs – sofosbuvir, velpatasvir, and voxilaprevir. Continuous oversight and quality assurance are vital to maintaining supply integrity, especially amid global supply chain uncertainties.
Key Takeaways
- Gilead’s Vosevi supply chain relies on multiple API suppliers across Europe, Asia, and North America.
- Strategic collaborations with CordenPharma and Samsung Bioepis are integral to API sourcing.
- Supply chain risks include raw material shortages, geopolitical factors, and pandemic disruptions.
- Certification and strict GMP compliance underpin supplier credibility.
- Diversification and global manufacturing footprints are critical to ensuring uninterrupted Vosevi availability.
FAQs
1. Who are the primary API suppliers for Vosevi?
The main API suppliers include CordenPharma (Germany and the US), Samsung Bioepis (South Korea), and specialized Chinese manufacturers such as Hainan New Century Aichem and Yuanzheng Pharmaceutical.
2. Does Gilead manufacture Vosevi’s APIs in-house?
No, Gilead primarily handles the final formulation and packaging, relying on external GMP-certified suppliers for the APIs.
3. How does Gilead ensure API quality and regulatory compliance?
Gilead conducts rigorous audits and mandates GMP standards for all API suppliers. Certification and import/export compliance are regularly monitored.
4. What are the supply chain risks associated with Vosevi?
Risks include raw material shortages, geopolitical tensions affecting Asian suppliers, COVID-19-related disruptions, and regulatory delays.
5. Are there alternative suppliers in case of disruptions?
Yes, Gilead maintains relationships with multiple suppliers and has contingency plans to switch or supplement sources if needed.
Sources:
[1] Gilead Sciences Official Website, Vosevi Product Details.
[2] FDA Approval Documentation for Vosevi (2017).
[3] Market Intelligence Reports on API Suppliers for Hepatitis C Drugs.
[4] Patent Filings and Industry Reports on Sofosbuvir, Velpatasvir, and Voxilaprevir Supply Chains.
[5] Good Manufacturing Practice (GMP) Certification Standards.
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