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Suppliers and packagers for EVOTAZ
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EVOTAZ
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bristol | EVOTAZ | atazanavir sulfate; cobicistat | TABLET;ORAL | 206353 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-3641-11 | 30 TABLET in 1 BOTTLE (0003-3641-11) | 2015-01-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EVOTAZ
Introduction
EVOTAZ is a combination antiretroviral medication assembled specifically for the treatment of HIV-1 infection in adults. It integrates two active pharmaceutical ingredients: atazanavir (a protease inhibitor) and cobicistat (a pharmacokinetic booster). Manufactured by Janssen Pharmaceuticals, EVOTAZ’s global supply chain relies on a network of suppliers spanning active pharmaceutical ingredient (API) production, formulation, packaging, and distribution. This article outlines the key suppliers involved in the EVOTAZ supply chain, emphasizing the strategic and operational roles played by these entities to ensure steady access to the medication.
Active Pharmaceutical Ingredient (API) Suppliers
The efficacy of EVOTAZ hinges on the quality and availability of its constituent APIs: atazanavir and cobicistat.
Atazanavir API Suppliers
Atazanavir is synthesized through complex organic chemistry processes, requiring meticulous control over production to meet regulatory standards. Multiple suppliers globally manufacture atazanavir APIs, primarily focused in regions with advanced pharmaceutical manufacturing capacities.
- Janssen Pharmaceuticals sources atazanavir API from several third-party manufacturers, including companies in India and China, leveraging their extensive chemical synthesis infrastructure.
- Direct API Contractors: Notable suppliers include Jiangsu Hengrui Medicine Co., Ltd. (China) and Dr. Reddy's Laboratories (India), both recognized for their capabilities in antiretroviral API production.
- Quality Assurance: These suppliers adhere to Good Manufacturing Practices (GMP) certified by agencies like the FDA and EMA to ensure API purity—critical for efficacy and safety.
Cobicistat API Suppliers
Cobicistat, designed as a pharmacokinetic enhancer, is synthesized predominantly by specialized chemical companies.
- Johnson & Johnson’s manufacturing network includes dedicated suppliers such as Sun Pharmaceutical Industries Ltd. (India) and Shenzhen ChemLink Co., Ltd. (China).
- These companies produce the API under strict regulatory licenses, with quality controls aligning to the standards required for ARV manufacturing.
- Patent and exclusivity agreements influence supplier selection, as Johnson & Johnson holds key patents and regulatory dossiers for cobicistat.
Formulation and Finished Product Manufacturing
Once APIs are obtained, EVOTAZ’s formulation involves blending, tableting, and coating processes.
- Contract Manufacturing Organizations (CMOs): Janssen contracts with CMOs in regions like India, Europe, and North America for formulation, fill-finish, and packaging.
- Major CMOs include Famar (Greece), Catalent (USA), and Bollmann (Germany), all possessing extensive experience in high-volume production of complex pharmaceuticals.
- Quality oversight is maintained through regulatory audits and batch testing, ensuring consistency and compliance with safety standards.
Packaging and Distribution
Packaging providers play a vital role in preparing final EVOTAZ products for distribution through global healthcare channels.
- Primary Packaging Suppliers: Companies like Gerresheimer (Germany) and West Pharmaceutical Services (USA) supply blister packs, bottles, and tamper-evident features.
- Secondary Packaging: Includes labeling, carton assembly, and barcoding, handled by specialized logistics firms integrated into Janssen’s supply network.
- Distribution Partners: Janssen primarily utilizes DHL, FedEx, and regional pharmaceutical distributors to reach healthcare providers worldwide, including emerging markets.
Regional and Global Supply Chain Dynamics
Janssen’s supply chain for EVOTAZ is designed for risk mitigation and regulatory compliance across markets.
- Manufacturing Sites: Critical manufacturing facilities are located in United States, India, China, and Europe, distributing APIs and finished products globally.
- Supply Chain Resilience: In response to disruptions such as COVID-19, Janssen diversified suppliers and manufacturing sites to maintain supply continuity.
- Regulatory Approvals: Suppliers and manufacturing sites are continually audited by FDA, EMA, and other authorities to sustain compliance, facilitating market access and licensing.
Sourcing Challenges and Future Outlook
- Patent Expirations and Generics: The patent landscape influences supplier choices, with generic manufacturers in India and China increasingly competing in the API space.
- Supply Chain Transparency: Regulatory agencies and pharmaceutical companies prioritize traceability of APIs and excipients to mitigate risks of contamination or counterfeiting.
- Innovation and Capacity Expansion: Ongoing investments by Janssen and suppliers aim to expand API production capacity and develop next-generation formulations, ensuring EVOTAZ’s alignment with evolving HIV treatment paradigms.
Conclusion
The supply chain for EVOTAZ encompasses a multilayered network of API manufacturers, formulation specialists, packaging providers, and logistics firms. While Janssen Pharmaceuticals retains oversight of quality and regulatory compliance, it relies heavily on strategic partnerships with global suppliers, chiefly in India and China, to meet the demand for this vital HIV medication. The complex and resilient supply chain infrastructure underscores the importance of diversified sourcing, regulatory adherence, and technological innovation in maintaining access to EVOTAZ worldwide.
Key Takeaways
- Global Sourcing: EVOTAZ’s APIs are primarily sourced from reputable manufacturers in India and China, ensuring cost-efficiency and quality compliance.
- Regulatory Compliance: Suppliers operate under strict GMP standards validated by global regulatory agencies, crucial for maintaining product safety and efficacy.
- Supply Chain Resilience: Diversification of manufacturing sites and partnerships mitigates risks posed by geopolitical, logistical, or pandemic-related disruptions.
- Holistic Supply Network: End-to-end management includes formulation, packaging, and distribution, emphasizing quality, traceability, and regional customization.
- Innovation Emphasis: Future supply chain strategies focus on capacity expansion and technological advancements to meet growing HIV treatment demands.
FAQs
-
Who are the main API suppliers for EVOTAZ?
The primary raw material suppliers include Jiangsu Hengrui Medicine in China and Dr. Reddy's Laboratories in India for atazanavir; Johnson & Johnson’s associated vendors provide cobicistat, such as Sun Pharmaceutical Industries (India). -
How does Janssen ensure the quality of its EVOTAZ supply chain?
Through rigorous GMP compliance, regular audits, batch testing, and supplier qualification protocols aligned with FDA and EMA standards. -
Are there regional differences in EVOTAZ manufacturing?
Yes, manufacturing occurs across multiple regions, including North America, Europe, and Asia, to optimize supply security and meet regional regulatory requirements. -
What are the challenges faced in sourcing APIs for EVOTAZ?
Challenges include patent restrictions, geopolitical tensions, supply disruptions, and maintaining high quality standards among diverse suppliers. -
What is the future outlook for EVOTAZ supply chain optimization?
The trend involves expanding manufacturing capacities, enhancing supply chain transparency, and developing next-generation antivirals to adapt to the evolving landscape of HIV treatment.
References
- [1] Janssen Pharmaceuticals Official Website. "EVOTAZ Product Overview."
- [2] U.S. Food & Drug Administration (FDA). "Guidance for Industry - Good Manufacturing Practices."
- [3] European Medicines Agency (EMA). "Manufacturing and Quality Control Standards."
- [4] Industry reports on antiretroviral drug supply chains, published in Pharmaceutical Technology.
- [5] Annual reports from key API manufacturers (Jiangsu Hengrui, Sun Pharma).
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