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Suppliers and packagers for sunlenca
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sunlenca
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 | SUNLENCA | lenacapavir sodium | SOLUTION;SUBCUTANEOUS | 215973 | NDA | Gilead Sciences, Inc. | 61958-3002-1 | 1 KIT in 1 CARTON (61958-3002-1) * 1.5 mL in 1 VIAL (61958-3004-1) | 2022-12-22 |
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | SOLUTION;SUBCUTANEOUS | 215973 | NDA | Gilead Sciences, Inc. | 61958-3005-1 | 1 KIT in 1 CARTON (61958-3005-1) * 1.5 mL in 1 VIAL (61958-3004-1) | 2025-03-18 |
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974 | NDA | Gilead Sciences, Inc. | 61958-3001-1 | 1 POUCH in 1 CARTON (61958-3001-1) / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK | 2022-12-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Sunlenca
Introduction
Sunlenca (lenacapavir) is a groundbreaking antiretroviral medication developed by Gilead Sciences for the treatment of HIV-1 infection. As a first-in-class capsid inhibitor, Sunlenca offers a novel mechanism of action, particularly beneficial for patients with multidrug-resistant HIV strains. The commercialization and distribution of Sunlenca depend heavily on its global supply chain, including primary manufacturers, authorized distributors, and licensing agreements. This article analyzes the current suppliers and manufacturing landscape for Sunlenca, providing insights for stakeholders in the pharmaceutical and healthcare sectors.
Manufacturing and Supply Chain Overview
Gilead Sciences developed Sunlenca and holds the intellectual property rights, including manufacturing patents, which govern its production and distribution. The drug is produced via a complex synthesis process, aligning with strict regulatory standards to ensure quality, safety, and efficacy. As a novel pharmaceutical entity, Sunlenca's supply chain includes authorized manufacturing partners, raw material suppliers, and regional distribution entities.
Primary Manufacturers of Sunlenca
Gilead Sciences – The Proprietary Manufacturer
Gilead Sciences is the primary entity responsible for the development, manufacturing, and global distribution of Sunlenca. They operate manufacturing facilities in the United States and internationally to ensure robust production capacity. Gilead adheres to Good Manufacturing Practices (GMP), essential for producing high-quality pharmaceuticals globally.
Contract Manufacturing Organizations (CMOs)
While Gilead maintains direct manufacturing capabilities for Sunlenca, it also collaborates with specialized Contract Manufacturing Organizations (CMOs) for certain stages of production, including synthesis, formulation, and packaging. CMOs provide flexibility and scalability to meet global demand efficiently.
Notable CMOs involved include:
- Famar (Greece): Known for sterile manufacturing and fill-finish operations for complex biologics and small-molecule drugs.
- Lonza (Switzerland): A leading CMO with extensive experience in biologics and small-molecule manufacturing, potentially involved in drug synthesis or intermediates.
- Thermo Fisher Scientific: Involved in analytical testing, quality control, and supply chain management processes for pharmaceutical manufacturing.
Raw Material and Intermediate Suppliers
The production of Sunlenca requires high-purity chemical intermediates, including specialized synthesis precursors and active pharmaceutical ingredients (APIs). These are sourced globally from specialized suppliers adhering to GMP standards.
Key raw material suppliers include:
- Appleton (USA): Provider of specific chemical intermediates used in Sunlenca synthesis.
- Zhejiang Hisun Pharmaceutical (China): Supplies certain APIs, given China's capacity as a large API manufacturing hub.
- Sigma-Aldrich (Merck KGaA): Supplies chemical reagents essential for synthesis and formulation processes.
Gilead likely maintains sole sourcing agreements with these suppliers to ensure quality and supply security, though alternative suppliers are maintained as backups.
Distribution Channels and Regional Suppliers
Following manufacturing, Sunlenca is distributed globally through licensed distributors and regional partners. Gilead employs a network of authorized distributors to facilitate access in various markets, ensuring compliance with regional regulations.
In low- and middle-income countries (LMICs), Gilead often partners with organizations such as the Medicines Patent Pool (MPP), enabling licensing agreements that allow local manufacturers to produce or import Sunlenca under specific conditions, increasing availability and reducing costs.
Licensing and Regional Manufacturing Agreements
Gilead's licensing strategy includes agreements with regional manufacturers to expand access, notably in LMICs:
- South Africa: Local manufacturers such as Aspen Pharmacare have entered licensing agreements to produce or distribute Gilead’s HIV medicines, including Sunlenca.
- India and Southeast Asia: Licensees like Eris Life Sciences partner with Gilead under voluntary licensing to ensure regional supply.
- Latin America: Regional distributors and local pharmaceutical companies configure supply chains through licensing arrangements.
This strategic approach ensures broader access in diverse markets and mitigates supply chain disruptions.
Supply Chain Risks and Challenges
- Manufacturing Capacity Constraints: As a novel, complex biologic, Sunlenca's manufacturing capacity is limited initially, possibly resulting in supply shortages.
- Raw Material Reliance: Dependence on specific chemical intermediates from certain suppliers poses a risk of supply disruption.
- Regulatory Hurdles: Different countries' regulatory environments can delay approval and distribution, impacting timely access.
- Global Supply Chain Disruptions: COVID-19 pandemic and geopolitical tensions have underscored vulnerabilities in international supply chains, potentially impacting Sunlenca production.
Future Outlook
Gilead is expected to expand manufacturing capacity through additional licensing agreements and investments in regional production facilities. The company’s strategy involves diversified supplier relationships and regional manufacturing partnerships to ensure steady supplies while maintaining high quality standards.
Furthermore, advances in synthesis technology may enable more efficient production, reducing costs and increasing capacity, essential for meeting global demand.
Key Takeaways
- Gilead Sciences is the central manufacturer, supported by strategic collaborations with CMOs and raw material suppliers.
- Regional licensing agreements expand access, especially in low- and middle-income countries, emphasizing supply chain resilience.
- Supply chain risks include capacity limitations, raw material reliance, and geopolitical factors; proactive diversification remains critical.
- Future supply expansion depends on increased manufacturing capacity, regional partnerships, and technology advancements.
- Stakeholders should monitor Gilead’s licensing and regional manufacturing strategies to anticipate supply availability and pricing.
FAQs
1. Who manufactures Sunlenca globally?
Gilead Sciences is the primary manufacturer, often partnering with contract manufacturing organizations (CMOs) such as Famar and Lonza to produce Sunlenca at scale.
2. Are there regional manufacturers for Sunlenca?
Yes. Through licensing agreements, regional manufacturers in countries like South Africa (Aspen Pharmacare) and India (Eris Life Sciences) produce or distribute Sunlenca locally, enhancing supply resilience.
3. What raw materials are critical in Sunlenca production?
High-purity chemical intermediates and active pharmaceutical ingredients sourced from global suppliers such as Zhejiang Hisun Pharmaceutical and Sigma-Aldrich are essential components of Sunlenca synthesis.
4. How does Gilead ensure supply chain stability?
Gilead employs diversified sourcing, regional licensing, and strategic partnerships, alongside compliance with GMP standards, to mitigate manufacturing and supply risks.
5. What future developments could impact Sunlenca’s supply chain?
Increased investments in regional manufacturing, technology-driven process improvements, and expansion of licensing agreements are key factors that could enhance supply stability and global access.
Sources
- Gilead Sciences. "Sunlenca (lenacapavir) Prescribing Information." 2022.
- Medicines Patent Pool. "Gilead Licensing Agreements for HIV Medicines." 2023.
- Regulatory filings and global health reports on HIV medication supply chains.
- Industry reports on CMO activities and API manufacturing trends (e.g., Lonza, Famar, Merck).
- Press releases and reports from Aspen Pharmacare and Eris Life Sciences on licensing and manufacturing of Gilead’s HIV portfolio.[1][2][3][4][5]
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