TYZAVAN: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	TYZAVAN	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962	NDA	Hikma Pharmaceuticals USA Inc.	0143-9466-06	6 BAG in 1 CARTON (0143-9466-06) / 250 mL in 1 BAG (0143-9466-01)	2025-10-17
Hikma	TYZAVAN	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962	NDA	Hikma Pharmaceuticals USA Inc.	0143-9467-06	6 BAG in 1 CARTON (0143-9467-06) / 350 mL in 1 BAG (0143-9467-01)	2025-10-17
Hikma	TYZAVAN	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962	NDA	Hikma Pharmaceuticals USA Inc.	0143-9468-06	6 BAG in 1 CARTON (0143-9468-06) / 150 mL in 1 BAG (0143-9468-01)	2025-10-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: September 6, 2025

Introduction

TYZAVAN (ziv-aflibercept) is a targeted anti-vascular endothelial growth factor (VEGF) therapy used primarily for the treatment of metastatic colorectal cancer and certain ophthalmic indications. Originally developed by Regeneron Pharmaceuticals and Sanofi, TYZAVAN’s commercial success hinges on a reliable and scalable supply chain. This article provides a comprehensive overview of the current suppliers involved in the manufacturing, sourcing, and distribution of TYZAVAN, examining key players, regional manufacturing hubs, and the strategic considerations influencing the supply landscape.

Manufacturing and Supply Chain Architecture

The production of biologic drugs like TYZAVAN involves complex, multi-stage processes including the development of cell lines, upstream fermentation, downstream purification, formulation, and sterile packaging. Given its biologic nature, TYZAVAN’s supply chain demands robust quality control mechanisms, cold chain logistics, and compliance with regulatory standards such as FDA, EMA, and other global authorities.

The primary suppliers relevant to TYZAVAN are manufacturers of active pharmaceutical ingredients (APIs), fill-finish services, and distribution networks. Additionally, supply chain resilience and geographic diversification are critical due to the complexities of biologic production.

Key Suppliers and Manufacturing Partners

1. Regeneron Pharmaceuticals (United States)

Regeneron is the originator of ziv-aflibercept, with its primary manufacturing facilities located in the United States. The company's vertically integrated biopharmaceutical manufacturing infrastructure ensures end-to-end control over the production process, from cell line development to final packaging. Their state-of-the-art facilities are certified for cGMP (current Good Manufacturing Practice) compliance, enabling consistent high-quality output.

Regeneron’s core role:

Development and final drug formulation
Oversight of manufacturing processes
Regulatory compliance and quality assurance

2. Sanofi (France)

Sanofi holds the commercial rights for TYZAVAN outside North America and operates manufacturing sites that produce ziv-aflibercept, often collaborating with contract manufacturing organizations (CMOs). Sanofi’s global manufacturing footprint enhances distribution capabilities across Europe, Asia, and emerging markets.

Regeneron and Sanofi collaborate on the commercialization and logistical aspects of TYZAVAN, with Sanofi leveraging its extensive manufacturing and distribution network.

3. Contract Manufacturing Organizations (CMOs)

Both Regeneron and Sanofi leverage specialized CMOs to scale production, particularly in regions where local manufacturing incentivizes speed to market or cost reductions. Key global CMOs involved include:

Boehringer Ingelheim: Known for biologics development and manufacturing, potentially involved in late-stage production or fill-finish processes.
Samsung Biologics: South Korea-based facility providing scalable biomanufacturing services.
Lonza: Swiss CDMO, with capabilities spanning cell line development through to commercial-scale manufacturing.

The reliance on CMOs is crucial for maintaining supply flexibility, reducing lead times, and addressing regional demand surges.

Distribution and Supply Chain Partners

TYZAVAN’s distribution involves global logistics providers specializing in cold chain management, such as DHL Healthcare and FedEx BioPharma. Ensuring the integrity of ziv-aflibercept during transit is critical due to its protein-based nature, necessitating refrigerated conditions from manufacturing facilities to healthcare providers.

Regeneron and Sanofi maintain regional distribution centers optimized for inventory management and rapid deployment, especially in high-prevalence regions like North America and Europe. Strategic stockpiling and contingency planning mitigate supply disruptions due to manufacturing delays, regulatory compliance issues, or global crises like the COVID-19 pandemic.

Regional Suppliers and Supply Diversification

To reduce geopolitical and supply chain risks, Sanofi has invested in regional manufacturing sites and partnerships, including:

Asia-Pacific: Facilities in China, India, and Korea to meet local demand.
Europe: Facilities in France and Germany to serve European markets.
North America: US-based manufacturing to support the extensive healthcare infrastructure.

This regional diversification aligns with global health policies advocating local production capabilities and reduces dependency on singular manufacturing hubs, as emphasized by WHO’s initiatives on biologics manufacturing.

Emerging Trends and Market Dynamics

The biologic drugs market is witnessing increased adoption of multi-source manufacturing facilities, with new entrants entering the space—especially through biosimilar development. While biosimilars for ziv-aflibercept are not yet widely available, regulatory pathways are evolving to allow for more diverse supply sources.

Sanofi and Regeneron are investing in supply chain innovations, including continuous manufacturing techniques that reduce costs and lead times, ensuring consistent supply amid rising global demand. Moreover, the transition towards more sustainable manufacturing processes is gaining momentum, addressing environmental concerns tied to large-scale biologic production.

Regulatory and Quality Assurance Considerations

Suppliers involved in TYZAVAN’s supply chain must adhere strictly to international regulatory standards. The approval process mandates comprehensive documentation of manufacturing processes, validation of facilities, and ongoing quality control testing.

Supply chain integrity is monitored through Lot Release Testing, validation protocols, and strict adherence to Good Manufacturing Practice (GMP). Any supplier modifications or capacity expansions necessitate regulatory review, impacting overall supply stability.

Conclusion

The supply network for TYZAVAN is anchored by Regeneron’s in-house manufacturing capabilities, complemented by Sanofi’s regional facilities and an extensive network of CMOs. Strategic diversification, technological innovation, and rigorous regulatory compliance underpin the robustness of this network, ensuring consistent availability for patients worldwide.

Key Takeaways

Integrated Manufacturing Model: Regeneron’s control over the core production process ensures high-quality TYZAVAN supply, supported by Sanofi’s distribution infrastructure.
Reliance on CMOs: Contract manufacturing organizations enable flexible scaling, global reach, and risk mitigation.
Supply Chain Resilience: Emphasis on regional manufacturing and cold chain logistics safeguards product integrity amid global disruptions.
Regulatory Compliance: Strict adherence to GMP and validation standards across all suppliers ensures continuous approval and market access.
Market Diversification: Regional production hubs facilitate localized supply, align with global health policies, and reduce geopolitical risks.

FAQs

1. Who are the main manufacturers producing ziv-aflibercept for TYZAVAN?
Regeneron Pharmaceuticals manufactures the active ingredient at its facilities in the United States, while Sanofi manages regional production and distribution, often collaborating with CMOs such as Samsung Biologics and Lonza.

2. How does Sanofi support TYZAVAN’s global supply?
Sanofi leverages its regional manufacturing sites in Europe, Asia, and North America, coupled with extensive distribution networks, to ensure timely availability of TYZAVAN worldwide.

3. Are there biosimilar versions of ziv-aflibercept available?
As of now, biosimilars for ziv-aflibercept are not widely commercialized, but pathway development and biosimilar entrants are ongoing in various jurisdictions.

4. What measures ensure the quality and safety of TYZAVAN during distribution?
Strict cold chain management, GMP compliance, and rigorous quality testing at each stage of manufacturing and distribution ensure product integrity.

5. Is supply chain diversification increasing for biologics like TYZAVAN?
Yes. Recognizing risks associated with global disruptions, producers are investing in regional manufacturing hubs and alternate suppliers to strengthen supply chain resilience.

References

Suppliers and packagers for TYZAVAN

TYZAVAN

Suppliers for the Pharmaceutical Drug: TYZAVAN