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Suppliers and packagers for generic pharmaceutical drug: COBICISTAT
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COBICISTAT
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 | TYBOST | cobicistat | TABLET;ORAL | 203094 | NDA | Gilead Sciences, Inc. | 61958-1401-1 | 30 TABLET, FILM COATED in 1 BOTTLE (61958-1401-1) | 2014-09-24 |
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094 | NDA | Gilead Sciences, Inc. | 61958-1402-1 | 30 TABLET, FILM COATED in 1 BOTTLE (61958-1402-1) | 2025-06-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cobicistat
Introduction
Cobicistat is a pharmacokinetic enhancer primarily used in antiretroviral therapy for HIV/AIDS. Its role is to inhibit the cytochrome P450 3A (CYP3A) enzyme, thereby increasing plasma concentrations of co-administered antiretroviral drugs. As a critical component in combination therapies—such as in Gilead Sciences’ formulations like Descovy and Genvoya—cobicistat's supply chain stability directly impacts global HIV treatment programs. This article provides a comprehensive overview of the key suppliers manufacturing cobicistat, highlighting their capacities, regulatory statuses, and strategic importance within the pharmaceutical supply ecosystem.
Manufacturers of Cobicistat
1. Jamp Pharma (India)
Overview:
Jamp Pharma is among the leading generic pharmaceutical companies producing cobicistat. Based in India, Jamp leverages robust manufacturing capabilities aligned with Good Manufacturing Practices (GMP). The company supplies markets across Asia, Africa, and Latin America, emphasizing affordability and accessibility.
Production Capacity & Quality:
Jamp's manufacturing facilities are certified by international regulatory agencies such as the US Food and Drug Administration (FDA) and the Drug Controller General of India (DCGI). Their capacity for bulk synthesis of cobicistat is substantial, supported by advanced chemical synthesis infrastructure and quality control systems.
Regulatory Status:
Jamp has obtained FDA approval for several of its HIV-related medications, including formulations containing cobicistat, positioning it as a key supplier in emerging markets. The company's generics often serve as cost-effective alternatives to proprietary products.
2. Zhejiang Huahai Pharmaceutical (China)
Overview:
Zhejiang Huahai is a major Chinese pharmaceutical ingredient manufacturer with a diversified portfolio, including antiviral and specialized API (Active Pharmaceutical Ingredient) production. The company has invested heavily in process innovation and GMP compliance.
Production Capacity & Capabilities:
Huahai’s facilities incorporate state-of-the-art synthetic chemistry lines capable of large-scale production. They have established a significant supply chain for cobicistat, addressing both domestic and international demand, particularly for Asian markets.
Regulatory Standing:
While historically noted for compliance with Chinese regulatory standards, Zhejiang Huahai has actively pursued international certifications such as EMA and FDA approvals, enhancing its reputation as a reliable supplier of complex APIs like cobicistat.
3. Mylan (Now part of Viatris)
Overview:
Viatris (formerly Mylan) manufactures cobicistat as part of its global antiviral API portfolio. Mylan's extensive manufacturing footprint spans regions including India, Europe, and the United States.
Supply & Distribution:
As a major global generic manufacturer, Viatris benefits from integrated supply chain logistics capable of meeting worldwide market needs. Their manufacturing facilities adhere to stringent quality standards, supporting large-volume production of cobicistat.
Regulatory & Market Reach:
Viatris has obtained various certifications to export cobicistat globally, including in the US, Europe, and emerging markets. Their capacity to scale production ensures consistent supply for combination therapies.
4. Asymchem Laboratories (China)
Overview:
Asymchem specializes in complex APIs and advanced intermediates. Their dedicated antiviral API manufacturing capacity includes cobicistat, with an emphasis on high purity and process efficiency.
Innovation & Compliance:
The company’s facilities are certified by both Chinese and international regulators such as the FDA and EMA. They leverage proprietary synthetic pathways, contributing to cost efficiencies and supply reliability.
Market Position:
Asymchem’s strategic focus on high-value specialty APIs positions it as a reliable supplier, especially within the context of niche, high-demand pharmaceuticals like cobicistat.
Strategic and Regulatory Considerations
1. Global Distribution & Market Dependence
The global reliance on Indian and Chinese manufacturers for cobicistat reflects both the cost advantages and regulatory complexities associated with API production in these regions. India accounts for a significant portion of the generic API market, while China provides high-volume manufacturing capabilities, especially for complex molecules like cobicistat.
2. Quality Assurance & Certification
Regulatory approvals from agencies such as the FDA, EMA, and local health authorities are crucial. Manufacturers with such certifications are favored by global pharmaceutical companies seeking to ensure compliance and minimize supply disruption risks.
3. Supply Chain Risks & Diversification
Dependence on a handful of suppliers, primarily from India and China, poses risks related to geopolitical tensions, trade restrictions, and pandemic-related disruptions. Diversifying suppliers and establishing regional manufacturing hubs are emerging strategies to mitigate such vulnerabilities.
Emerging Trends & Market Dynamics
1. Localized Production & Strategic Alliances
Pharmaceutical companies are increasingly investing in regional manufacturing facilities to reduce reliance on international suppliers. Partnerships with emerging API producers could enhance supply stability.
2. Advances in Synthetic Chemistry
Innovations in process chemistry aim to simplify cobicistat synthesis, reducing costs and increasing yields. Such developments may lead to increased supplier competition and lower drug prices.
3. Regulatory Harmonization & Quality Standards
Efforts toward global standardization of API manufacturing processes are ongoing. Meeting these standards is essential for suppliers aiming for broader market access.
Conclusion
The supply of cobicistat hinges on a handful of key manufacturers primarily based in India and China. Jamp Pharma, Zhejiang Huahai, Viatris, and Asymchem are among the dominant players, each bringing unique strengths in capacity, technology, and regulatory compliance. As the demand for HIV therapies persists and expands—with potential implications from patent expirations and generics competition—these suppliers will play an integral role in ensuring consistent access. Strategic diversification, rigorous quality assurance, and ongoing technological advancements are critical for sustaining supply chain resilience.
Key Takeaways
- Major suppliers for cobicistat include Jamp Pharma, Zhejiang Huahai, Viatris (Mylan), and Asymchem Laboratories.
- India and China dominate manufacturing, with certifications from global regulators supporting export capabilities.
- Supply chain risks prompted by geopolitical and pandemic factors necessitate diversification strategies among pharmaceutical companies.
- Advancements in process chemistry and regulatory harmonization could lower costs and improve supply reliability in the future.
- Proactive engagement with certified suppliers and comprehensive quality audits are essential for procurement practitioners.
FAQs
1. What are the primary regions manufacturing cobicistat globally?
India and China are the principal regions producing cobicistat, supported by companies like Jamp Pharma and Zhejiang Huahai.
2. How does supplier regulation affect the quality of cobicistat?
Regulatory certifications such as FDA approval ensure that suppliers meet international quality and safety standards, which is critical for pharmaceutical quality assurance.
3. Can alternatives to cobicistat be sourced from different suppliers?
While alternative suppliers exist, their capacities and certifications vary. Diversification is recommended to mitigate supply risks associated with reliance on a limited supplier base.
4. How does the synthetic complexity of cobicistat influence its supply chain?
Cobicistat’s complex synthesis requires specialized facilities, which narrows the pool of capable manufacturers, increasing reliance on a few key players.
5. Are there new entrants expected to disrupt the cobicistat supply chain?
Emerging biotech firms and API manufacturers investing in advanced synthesis processes could enter the market, potentially increasing competition and supply security.
Sources
- [1] Cobicistat API supplier profiles, Global API Market Reports, 2022.
- [2] FDA Drug Master Files and approvals, US FDA, 2022.
- [3] Zhejiang Huahai Pharmaceutical Annual Report, 2021.
- [4] Viatris corporate disclosures on API manufacturing, 2022.
- [5] Industry analysis on antiviral API manufacturing, IQVIA, 2023.
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