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Suppliers and packagers for generic pharmaceutical drug: CABOTEGRAVIR
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CABOTEGRAVIR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499 | NDA | ViiV Healthcare Company | 49702-264-23 | 1 KIT in 1 CARTON (49702-264-23) * 3 mL in 1 VIAL (49702-238-03) | 2021-12-20 |
| Viiv Hlthcare | APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499 | NDA | ViiV Healthcare Company | 49702-280-63 | 1 KIT in 1 CARTON (49702-280-63) * 3 mL in 1 VIAL (49702-238-61) | 2024-03-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CABOTEGRAVIR
Introduction
Cabotegravir, marketed under brand names such as Apretude, is a long-acting injectable antiretroviral medication primarily used in HIV prevention and treatment. As a selective integrase strand transfer inhibitor (INSTI), cabotegravir has gained significant traction within the pharmaceutical landscape due to its efficacy, reduced dosing frequency, and improved patient adherence. This article provides an in-depth analysis of the key suppliers involved in the manufacturing and distribution of cabotegravir, examining their roles, market dynamics, and strategic implications for stakeholders.
Overview of Cabotegravir Production
Developed by ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK) and Pfizer, cabotegravir's production involves complex synthetic pathways, requiring high-quality active pharmaceutical ingredients (APIs) and stringent manufacturing controls. Ensuring a secure, scalable, and compliant supply chain remains vital, especially given the global demand for HIV prevention tools.
Key Suppliers of Cabotegravir
1. ViiV Healthcare (Lead Developer and Global Supplier)
ViiV Healthcare holds the proprietary rights to cabotegravir and is the primary manufacturer and distributor of the drug globally. The company’s manufacturing facilities, strategically located across the UK (UK-GSK site) and the United States, integrate advanced API synthesis and formulation capabilities to meet regulatory standards, including Good Manufacturing Practice (GMP) guidelines.
ViiV’s extensive global distribution network ensures a consistent supply, especially in regions with high HIV prevalence. The company also collaborates with prequalified generic manufacturers to expand access, particularly in low- and middle-income countries (LMICs).
2. API Manufacturers
China and India dominate the supply chain for active pharmaceutical ingredient (API) synthesis, serving as vital nodes in the global vertical integration landscape. Several API manufacturers supply intermediary and final-grade API to ViiV and generic producers:
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Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Known for complex pharmaceutical synthesis, potentially involved in API supply or contract manufacturing for generic firms.
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Sun Pharmaceutical Industries Ltd. (India): One of the world's largest generic API manufacturers, with capabilities in HIV antiretroviral APIs including integrase inhibitors.
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Cipla Ltd. (India): Engaged in manufacturing APIs and finished formulations; Cipla is a prominent generic producer of cabotegravir-based products, including long-acting injectables.
3. Formulation and Injection Production
Specialized pharmaceutical contract manufacturing organizations (CMOs) support formulation and injectable production, ensuring stability of long-acting formulations. Companies such as Samsung Biologics (South Korea) and Lonza (Switzerland) have scaled up injectable production capacity, critical for meeting global demand and ensuring supply chain resilience.
4. Generic and Biosimilar Manufacturers
In many LMICs, local or regional generic manufacturers produce cabotegravir under licensing agreements or government contracts to increase access. These producers often source APIs from the aforementioned Chinese and Indian manufacturers.
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Hetero Labs (India): Produces generic antiretroviral drugs, potentially including cabotegravir formulations.
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Mylan (now part of Viatris): Engaged in generic HIV drugs, with some formulations in development or market.
5. Supply Chain and Raw Material Suppliers
Suppliers of key raw materials, including specialty chemicals, solvents, and excipients, are based globally. Such raw material suppliers include companies like Avocado chemicals and Corning, ensuring the purity and stability of APIs and formulations.
Strategic and Market Considerations
The supply chain for cabotegravir is characterized by high technological barriers, requiring precise synthesis, stability testing, and regulatory compliance. While ViiV Healthcare remains the leader, increasing pressure from generics has driven a vibrant ecosystem of OEMs and contract manufacturers.
Regional dynamics influence supply security; China's API manufacturing capacity benefits global availability but faces geopolitical risks, while Indian manufacturers benefit from cost advantages and extensive export networks. Supply constraints in early commercialization phases prompted strategic stockpiles and collaborative manufacturing agreements.
Additionally, the ongoing expansion of manufacturing capacities in Africa and Asia aims to improve access and reduce costs, especially critical for regional HIV prevention programs.
Risks and Opportunities in Supplier Ecosystem
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Supply Disruptions: Factors like geopolitical tensions, COVID-19 supply chain interruptions, and raw material shortages pose risks. Diversification and local manufacturing investments are key mitigation strategies.
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Regulatory Hurdles: Compliance with international standards ensures market access. Suppliers with strong regulatory track records—particularly in the US FDA, EMA, and WHO prequalification—gain competitive advantages.
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Patent and Licensing Opportunities: Strategic partnerships and voluntary licensing agreements, notably those driven by ViiV and WHO initiatives, expand manufacturing access and foster competitive pricing.
Conclusion
The supply chain for cabotegravir involves a comprehensive network of API producers, formulations specialists, and regional manufacturers, primarily anchored in China and India, with ViiV Healthcare acting as the central orchestrator. As demand for long-acting injectable HIV prophylactics surges, ensuring resilient, compliant, and scalable supply channels remains critical for global access initiatives.
Key Takeaways
- Primary Suppliers: ViiV Healthcare is the main global supplier, supported by significant API manufacturing capacity in China (Zhejiang Hisun) and India (Sun Pharma, Cipla).
- Supply Chain Resilience: Geographic diversification, strategic stockpiling, and capacity expansion are crucial in mitigating disruptions.
- Regulatory Scrutiny: Suppliers must adhere to stringent GMP and prequalification standards to maintain market access.
- Market Dynamics: Growing demand for generic formulations and regional manufacturing presents opportunities for new entrants and partnerships.
- Future Outlook: Innovations in API synthesis, manufacturing scale-up, and licensing will influence supply chain robustness and global access.
FAQs
1. Who are the leading API manufacturers for cabotegravir?
Major API suppliers include Chinese companies like Zhejiang Hisun Pharmaceutical and Indian firms such as Sun Pharmaceutical Industries and Cipla, which produce raw materials and final APIs for both branded and generic formulations.
2. How does ViiV Healthcare ensure supply chain security for cabotegravir?
ViiV collaborates with multiple manufacturing partners, maintains strategic stockpiles, invests in capacity expansion, and adheres to stringent regulatory standards to ensure uninterrupted supply.
3. Are there regional manufacturers for cabotegravir?
Yes. Several regional generic manufacturers in Africa, India, and Southeast Asia produce cabotegravir formulations under licensing, to improve accessibility, especially in LMICs.
4. What risks threaten the supply of cabotegravir?
Supply disruptions may stem from geopolitical tensions, raw material shortages, regulatory delays, or manufacturing issues at any point in the complex supply chain.
5. What is the future outlook for cabotegravir suppliers?
The increasing global adoption of long-acting HIV treatment offers growth opportunities for existing suppliers and new entrants, with a focus on expanding manufacturing capacity, reducing costs, and fostering licensing agreements.
References
[1] ViiV Healthcare. "Cabotegravir for HIV Prevention." ViiV Healthcare, 2023.
[2] World Health Organization. "Prequalification of Medicines Programme." WHO, 2022.
[3] Sun Pharmaceutical Industries Ltd. Annual Report 2022.
[4] Zhejiang Hisun Pharmaceutical Co., Ltd. Capabilities Overview, 2022.
[5] GlobalData. "HIV Antiretroviral Market Report," 2023.
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