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Suppliers and packagers for symtuza
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symtuza
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455 | NDA | Janssen Products LP | 59676-800-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30) | 2018-07-17 |
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455 | NDA | Janssen Products LP | 59676-800-99 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99) | 2018-07-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Symtuza
Introduction
Symtuza, a combination antiretroviral medication, is used predominantly in the management of HIV-1 infection. Developed by Johnson & Johnson’s subsidiary Janssen Pharmaceuticals, Symtuza integrates four active pharmaceutical ingredients (APIs): darunavir, cobicistat, emtricitabine, and tenofovir alafenamide. The complexity of its formulation necessitates a well-structured supply chain involving multiple suppliers across various stages—from active pharmaceutical ingredient (API) production to finished dosage manufacturing. Understanding the key suppliers of Symtuza is essential for stakeholders involved in procurement, manufacturing, and regulatory oversight.
Manufacturing Components of Symtuza
Symtuza’s manufacturing involves sourcing APIs and excipients from specialized suppliers, followed by formulation, assembly, and packaging. Its multi-drug composition calls for robust supply chains to ensure quality, compliance, and uninterrupted supply.
Active Pharmaceutical Ingredient (API) Suppliers
1. Darunavir
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Primary Suppliers: Multiple firms globally produce darunavir, including:
- Hetero Labs (India) — a dominant manufacturer with FDA and EMA approvals.
- Mitsubishi Tanabe Pharma (Japan) — supplies for various markets.
- Sichuan Endeavor Pharmaceutical (China) — emerging supplier in the API space.
- Viatris (formerly Mylan) — supplies darunavir outside of Symtuza's licensed scope.
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Quality and Supply Chain Considerations: Hetero Labs, being a major supplier, provides high-quality APIs adhering to international standards. The consolidation of suppliers in India and China underscores the importance of diversified sourcing to mitigate geopolitical and supply disruption risks.
2. Cobicistat
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Suppliers: Cobicistat is a proprietary pharmacokinetic enhancer developed by Gilead Sciences. However, Johnson & Johnson may source cobicistat from:
- Thermo Fisher Scientific (via contract manufacturing organizations—CMOs).
- Cipla (India) — involved in manufacturing certain versions of cobicistat.
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Manufacturing Notes: Cobicistat synthesis is complex, involving specialized processes, necessitating high-quality CMOs with strict GMP compliance.
3. Emtricitabine
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Major Suppliers:
- Lupin Limited (India): One of the largest providers of emtricitabine globally.
- Hetero Labs (India): Another key supplier.
- Mylan (Viatris): Supplies emtricitabine as part of their HIV portfolio.
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Industry Insights: Indian generics manufacturers dominate the emtricitabine supply market, supported by extensive API manufacturing infrastructure and compliance with global standards.
4. Tenofovir Alafenamide (TAF)
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Primary Suppliers:
- Gilead Sciences: Holds patents and manufacturing rights, primarily producing APIs in-house or via licensed CMOs.
- Fujifilm Toyama Chemical: Licensed to produce TAF; supplies are integrated into the supply chain for products like Symtuza.
- Thermo Fisher Scientific: May assist in large-scale manufacturing for specific markets.
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Supply Chain Notes: Due to patent protections, Gilead controls TAF production sources, with limited licensing to external manufacturers.
Finished Dosage Formulation and Packaging
Once APIs are sourced, they undergo blending, tablet compression, and packaging:
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Contract Manufacturers (CMOs): Major pharmaceutical companies like Janssen's own manufacturing plants and regional CMOs handle the formulation process. Notable facilities include:
- Janssen’s own manufacturing sites in the U.S., Belgium, and India.
- External CMOs such as Catalent, Recipharm, and Samsung Biologics, which assist with formulation and packaging.
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Packaging Suppliers: Providers like Berry Global and Amcor supply primary packaging materials ensuring product stability and compliance.
Distribution and Supply Chain Integrity
Effective distribution networks—regulated by health authorities globally—are critical. Distribution partners ensure product availability across different regions while maintaining cold chain and storage requirements:
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Distribution Partners: Contract logistics providers such as McKesson, AmerisourceBergen, and regional logistics firms support global distribution.
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Regulatory Compliance: Suppliers and distributors adhere to international standards, including Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
Risks and Challenges in the Supply Chain
- Patent and Licensing Limitations: Gilead’s patent rights over TAF restrict external manufacturing, creating reliance on licensed suppliers.
- Geopolitical Risks: Concentration of manufacturing in India and China exposes supply chains to geopolitical disruptions.
- Regulatory Hurdles: Variations in regulatory approvals across countries can delay supply.
- Quality Assurance: Ensuring high GMP standards across diverse suppliers is critical to prevent recalls or supply interruptions.
Recent Trends Influencing Suppliers
- Manufacturing Diversification: Pharmaceuticals increasingly diversify supplier bases to mitigate risks, exemplified by Janssen’s layered sourcing strategy.
- Vertical Integration: Gilead’s control over TAF supply underscores vertical integration trends to safeguard proprietary APIs.
- Global Expansion: Supply chain adjustments are ongoing to meet global demand, especially in Africa and Asia where HIV prevalence is high.
Conclusion
The supply chain for Symtuza extends across multiple tiers, dominated by Indian and Chinese API manufacturers and global CMOs specializing in formulation and packaging. Major contributors include Hetero Labs, Lupin, and Gilead Sciences, each playing a pivotal role in ensuring the drug's availability. The strategic management of these suppliers, coupled with rigorous quality oversight and diversification, underpins the reliable supply of Symtuza worldwide.
Key Takeaways
- Symtuza’s supply chain involves a complex network of APIs, with key suppliers in India, China, and licensed manufacturers globally.
- Indian manufacturers dominate in APIs such as emtricitabine and darunavir, contributing significantly to global supply.
- Gilead maintains control over TAF production through licensing agreements, emphasizing the importance of proprietary APIs.
- Contract manufacturing organizations play a crucial role in formulation, blending, and packaging, often collaborating with the original manufacturers.
- Supply chain resilience depends on diversification, quality assurance, and compliance with international standards amid geopolitical and regulatory challenges.
FAQs
1. Who are the primary API suppliers for Symtuza?
Major API suppliers include Hetero Labs and Lupin in India, Mitsubishi Tanabe Pharma in Japan, and licensed manufacturers like Gilead for tenofovir alafenamide.
2. Does Gilead supply TAF for Symtuza?
Yes. Gilead Science controls TAF production, licensing manufacturing to qualified firms like Fujifilm Toyama Chemical, ensuring proprietary API supply.
3. Are there regional variations in Symtuza’s manufacturing?
While core APIs are sourced globally, final formulation and packaging often occur in regional facilities to meet local regulatory requirements.
4. What risks threaten Symtuza’s supply chain?
Primary risks include geopolitical disruptions, patent enforcement affecting API licensing, quality variability among suppliers, and global regulatory changes.
5. How does Janssen ensure supply chain continuity?
Janssen employs diversification of suppliers, multiple manufacturing hubs, stringent quality controls, and strategic inventory management to mitigate disruptions.
Sources:
[1] Johnson & Johnson Official Website, Symtuza Product Details
[2] Gilead Sciences Licensing Agreements
[3] Indian API Manufacturers’ Industry Reports
[4] U.S. Food and Drug Administration (FDA) Approved Drug Listings
[5] Market Analysis Reports on Pharmaceutical Supply Chains
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