Share This Page
Suppliers and packagers for genvoya
✉ Email this page to a colleague
genvoya
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 | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561 | NDA | Gilead Sciences, Inc. | 61958-1901-1 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1) | 2015-11-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Genvoya
Introduction
Genvoya is a branded antiretroviral medication developed by Gilead Sciences for the treatment of HIV-1 infection. The drug combines four active ingredients—elvitegravir (an integrase inhibitor), cobicistat (a pharmacokinetic booster), emtricitabine, and tenofovir alafenamide—in a fixed-dose single tablet. As a combination therapy, Genvoya's supply chain involves multiple specialized pharmaceutical components, active pharmaceutical ingredient (API) manufacturers, excipient providers, and contract manufacturing organizations (CMOs). Navigating Genvoya’s supplier landscape provides essential insight into its production reliability and market stability.
This analysis focuses on identifying and understanding the key suppliers involved in Genvoya's production, emphasizing the strategic importance of each source in ensuring consistent supply and regulatory compliance.
Active Pharmaceutical Ingredient (API) Suppliers
The core of Genvoya’s manufacturing process hinges on its four active ingredients. Gilead Sciences sources these APIs from a diversified network of reputable manufacturers, often relying on global supply chains.
1. Elvitegravir
Elvitegravir, an integrase inhibitor, is proprietary to Gilead but manufactured through licensed or in-house production facilities. Gilead maintains strict control over its API to safeguard quality and patent rights. Although Gilead is the primary producer, some APIs may be sourced from licensed suppliers in countries such as China and India, which are major API manufacturing hubs.
2. Cobicistat
Cobicistat functions as a pharmacokinetic enhancer in Genvoya, boosting the bioavailability of elvitegravir. Gilead either supplies cobicistat directly or contracts third-party API manufacturers. Notably, the global API manufacturing landscape includes firms like Zhejiang Huahai Pharmaceutical (China), Dr. Reddy’s Laboratories (India), and other reputed suppliers. These companies possess the capacity to produce cobicistat under stringent quality controls.
3. Emtricitabine
Emtricitabine APIs are predominantly sourced from established API producers in India and China. Companies such as Cipla and Hetero Labs are known suppliers of emtricitabine APIs at a commercial scale. Gilead likely uses these or equivalent suppliers, ensuring adherence to Good Manufacturing Practices (GMP).
4. Tenofovir Alafenamide (TAF)
TAF’s complexity requires sophisticated synthesis, and Gilead has historically relied on specialized manufacturers. Several companies, including Hetero Labs, device manufacturing partnerships, and other Asian API producers, supply TAF. Gilead’s TAF APIs are likely sourced from these or similar suppliers, given their proven capacity to produce high-quality TAF at scale.
Excipients and Formulation Components
Besides APIs, Genvoya's manufacturing involves excipients—filling agents, binders, disintegrants, etc.—which are supplied by a broad range of excipient manufacturers globally. Large global suppliers like BASF, Ashland, and JRS Pharma supply these constituents adhering to pharmaceutical standards. These materials are critical to ensuring drug stability, bioavailability, and patient safety.
Contract Manufacturing Organizations (CMOs) and Formulation
Gilead outsources final formulation, tablet compression, and packaging to specialized CMOs. Leading companies such as Samsung BioLogics, Lonza, and Catalent have the capacity and GMP-compliant facilities to produce Genvoya at commercial scale. These organizations provide end-to-end manufacturing, from raw API processing to finished product packaging.
Key CMO Roles include:
- Formulation and Tablet Compression: Ensuring the stability and bioavailability of the combined API components.
- Packaging: Maintaining product integrity, tamper evidence, and compliance with regulatory standards.
Supply Chain Dynamics and Market Considerations
The global geopolitical landscape, pandemic disruptions, and regulatory compliance influence Genvoya suppliers. Gilead’s strategic sourcing of multiple API manufacturers—particularly in India and China—serves as a risk mitigation strategy against supply disruptions.
The reliance on API suppliers from emerging markets necessitates rigorous quality assurance protocols. Gilead’s engagement with suppliers is characterized by extensive audits, certifications, and continuous monitoring to meet FDA, EMA, and other regulatory standards.
Emerging Trends and Future Directions
The pharmaceutical industry is witnessing heightened scrutiny on supply chain resilience, especially for HIV medications like Genvoya. Gilead is likely diversifying supplier relationships further, exploring local manufacturing options, and investing in manufacturing capacity expansion. Additionally, the shift toward Cytosolic alternative APIs and synthetic pathways for TAF indicates ongoing innovations which could affect supplier dynamics.
Furthermore, the increasing trend toward API regionalization aims to reduce dependency on long-distance supply chains, especially in light of international trade uncertainties.
Conclusion
Genvoya’s supply chain comprises a complex network of API manufacturers, excipient suppliers, and contract manufacturers. The primary API sources include global pharmaceutical companies and manufacturers in India and China, with Gilead maintaining tight quality oversight. Contract manufacturers like Samsung BioLogics and Catalent play vital roles in final formulation and packaging, ensuring the product's cost-effectiveness and high standards.
Understanding these supplier relationships provides insights into Genvoya’s potential vulnerabilities, strategic resilience, and opportunities for innovation. As demand for HIV therapies continues to grow, supplier stability and diversification will remain essential to ensuring sustained product availability.
Key Takeaways
- Genvoya's core ingredients are sourced from established global API suppliers, predominantly in India and China, with Gilead maintaining strict quality controls.
- The complexity of TAF synthesis necessitates partnerships with specialized manufacturers capable of high-quality production.
- Contract manufacturing is vital to Genvoya's final formulation and packaging, with companies like Samsung BioLogics and Catalent serving key roles.
- Supply chain resilience is increasingly prioritized, with efforts to diversify supplier bases and explore localized manufacturing.
- Regulatory compliance and quality assurance are central to maintaining uninterrupted Genvoya supply, especially amid geopolitical and logistical challenges.
FAQs
1. Who are the primary API suppliers for Genvoya?
Genvoya's APIs—elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide—are mainly sourced from manufacturers in India and China, such as Hetero Labs, Zhejiang Huahai, and Dr. Reddy’s Laboratories, under strict quality controls.
2. Does Gilead produce all components of Genvoya in-house?
While Gilead maintains manufacturing facilities for key APIs, it also relies heavily on licensed external suppliers and CMOs for formulation, packaging, and some API production to ensure supply flexibility and cost efficiency.
3. How does supplier diversity impact Genvoya’s supply chain?
Diversification minimizes disruptions, mitigates geopolitical risks, and helps meet global demand; however, it also requires rigorous quality oversight to maintain product standards.
4. Are there emerging suppliers or regions influencing Genvoya's future supply chain?
Yes, increased focus on regional manufacturing and local API production, especially in North America and Europe, is emerging to reduce dependencies on Asian suppliers amid geopolitical tensions.
5. What measures does Gilead take to ensure supply chain security?
Gilead implements comprehensive supplier qualification programs, regular audits, quality assurance protocols, and contractual safeguards to uphold GMP standards and ensure uninterrupted supply.
References
- Gilead Sciences. (2022). Genvoya Product Overview.
- U.S. Food & Drug Administration. (2023). Genvoya Approval and Regulatory Details.
- MarketWatch. (2023). Global API Manufacturing Trends.
- Pharmaceutical Technology. (2022). Supply Chain Strategies in HIV Medication Production.
- Industry Reports. (2023). API Supplier Market Shares and Outlook.
More… ↓
