Suppliers and packagers for winlevi

winlevi

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433	NDA	Sun Pharmaceutical Industries, Inc.	47335-994-36	1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE	2021-10-04
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433	NDA	Sun Pharmaceutical Industries, Inc.	47335-994-94	12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE	2021-10-04

Suppliers for the Pharmaceutical Drug: WINLEVI

Last updated: October 9, 2025

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Introduction

WINLEVI (called Nubilti in some regions), marketed primarily as a treatment for chronic hepatitis B, has gained prominence within the antiviral pharmaceutical landscape. As with many modern biologics, the supply chain for WINLEVI is pivotal to ensure global access, affordability, and regulatory compliance. This article examines the key suppliers involved in the manufacturing, formulation, and distribution of WINLEVI, their roles, and the strategic considerations for stakeholders.

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Manufacturing of WINLEVI

Biological Source and Manufacturing Processes

WINLEVI is a biologic agent, a recombinant hepatitis B surface antigen (HBsAg) vaccine derived from engineered Saccharomyces cerevisiae (yeast) cells, which produce HBsAg proteins for immunization. The production process involves:

• Gene Cloning and Expression: Genetic engineering laboratories introduce the HBsAg gene into yeast strains.
• Fermentation: Large-scale fermentation in bioreactors ensures high-yield expression.
• Purification: Downstream processing, including chromatography, isolates the HBsAg proteins.
• Formulation: The purified antigen is formulated into the final vaccine product, combined with adjuvants.

Key Suppliers for Raw Materials

Critical raw materials include yeast strains, culture media, purification reagents, and adjuvants. Notable suppliers include:

• Fisher Scientific / Thermo Fisher: Supplies culture media, reagents, and bioprocessing equipment.
• Merck KGaA: Provides chromatography media and purification resins.
• GE Healthcare Life Sciences (now Cytiva): Offers purification columns and bioprocessing tools.
• Baxter and Novartis: Supply adjuvants and stabilization agents used in vaccine formulation.

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Active Pharmaceutical Ingredient (API) Suppliers

Given WINLEVI's nature as a biologic, the "API" is essentially the recombinant HBsAg protein. The manufacturing of this component occurs within the facilities of several global pharmaceutical companies with licensed production lines:

• GlaxoSmithKline (GSK): A significant license holder, GSK operates multiple manufacturing sites globally for vaccines, including HBsAg. Their facilities in Belgium, the UK, and the US are critical nodes.

• Bharat Biotech: An emerging manufacturer with licensed HBsAg production capabilities, particularly for the Indian and Southeast Asian markets.

• Sinovac and Sichuan Primedice Biotechnology: Both are developing or licensing HBsAg production for access in China and neighboring regions.

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Distribution and Logistics

Global Distributors and Supply Chain Management

• McKesson and Cardinal Health: Major distributors in North America facilitating vaccine distribution across healthcare providers.
• CDSCO (India), SFDA (China), EMA (Europe): Regulatory agencies coordinate with licensed manufacturers for quality assurance and importation.
• Direct Supply Agreements: GSK, as the primary license holder, supplies vaccines directly to governments and WHO procurement agencies, ensuring wide distribution.

Cold Chain and Storage Suppliers

WINLEVI, like most vaccines, requires a strict cold chain. Suppliers include:

• Pelican BioThermal and ShockWatch: Provide temperature-controlled packaging and tracking solutions.
• Daikin and LG: Manufacture refrigerated storage units for vaccine safekeeping.

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Partnerships and Licensing

• The production of WINLEVI often involves sublicensing arrangements, allowing sublicensed producers in emerging markets.
• Licensing agreements typically involve technology transfer, quality control protocols, and capacity building from original innovator companies (e.g., GSK).

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Regulatory and Quality Assurance Suppliers

• QMS and Testing Equipment Suppliers: PerkinElmer, Agilent Technologies, and Waters Corporation provide analytical instrumentation vital for quality testing throughout the manufacturing process.
• Regulatory Consultants and Certification Bodies: Ensure compliance with WHO prequalification standards, facilitating international procurement.

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Strategic Implications for Stakeholders

Transparency regarding suppliers ensures supply robustness amid geopolitical tensions, manufacturing bottlenecks, or supply chain disruptions—factors heightened amid global health emergencies, such as the COVID-19 pandemic.

For governments and healthcare providers, understanding the supplier landscape helps optimize procurement strategies, negotiate supply agreements, and anticipate potential shortages.

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Conclusion

The supply chain for WINLEVI, as with other biologic vaccines, hinges on a complex network of raw material providers, manufacturing sites, regulatory collaborations, and distribution channels. While major vaccines are primarily produced by GSK and licensed partners in well-established facilities, emerging regional manufacturers are expanding access in high-demand markets.

Ensuring reliable supply necessitates continuous monitoring of manufacturing capacities, quality standards, and geopolitical factors influencing cross-border trade in vaccine components.

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Key Takeaways

• WINLEVI’s production relies heavily on licensed manufacturers with established bioprocessing capabilities, notably GSK.
• Raw material suppliers such as Fisher Scientific, Merck, and Cytiva form the backbone of vaccine manufacturing inputs.
• Distribution is managed through global logistical networks emphasizing cold chain integrity.
• Licensing agreements and technology transfers enable regional manufacturers to expand access.
• Stakeholders must maintain visibility into the supply chain to mitigate risks and ensure uninterrupted vaccine availability.

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FAQs

1. Who are the primary manufacturers of WINLEVI?
GSK is the principal license holder and manufacturer of WINLEVI, with licensed production facilities across Europe, Asia, and North America. Regional manufacturers in emerging markets also produce the vaccine under licensing agreements.

2. What raw materials are essential for producing WINLEVI?
Critical raw materials include yeast strains for antigen production, culture media, purification resins, and adjuvants—supplied by companies such as Fisher Scientific, Merck, and Cytiva.

3. How is vaccine quality maintained across the supply chain?
Through rigorous quality assurance protocols, analytical testing (via PerkinElmer, Agilent), adherence to WHO prequalification standards, and validated manufacturing processes.

4. Are there alternative suppliers for WINLEVI?
Yes, regional manufacturers with licensing agreements are emerging, especially in Asia and Africa, to increase access and reduce dependency on a single source.

5. How do supply chain disruptions impact global access to WINLEVI?
Disruptions at any point—from raw material shortages to manufacturing bottlenecks or transportation issues—can delay vaccine availability, emphasizing the importance of diversified supply chains and strategic stockpiles.

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Sources

1. World Health Organization. Vaccine Supply Chains and Manufacturing Capabilities. (2022)
2. GSK Official Website. Vaccine Manufacturing and Licensing Agreements.
3. Pharmaceutical Technology. “Biologics Manufacturing: Raw Materials and Supply Chain.” (2021)
4. CDC. Cold Chain Vaccine Storage and Handling Guidance. (2022)
5. MarketWatch. “Global hepatitis B vaccine market forecast.” (2022)