Suppliers and packagers for cytalux

cytalux

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907	NDA	On Target Laboratories, Inc.	81052-138-10	10 CARTON in 1 CARTON (81052-138-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.6 mL in 1 VIAL, SINGLE-DOSE (81052-138-01)	2021-11-29

Suppliers for the Pharmaceutical Drug: Cytalux

Last updated: July 28, 2025

Introduction

Cytalux (SILYMARSTAT) is a novel fluorescence imaging agent used in ovarian cancer surgeries to enhance tumor visualization. As a relatively recent entrant in the oncology surgical arena, its manufacturing and supply are controlled by specific pharmaceutical companies, primarily under licensing agreements with the developer, Cytalux, Inc. The following analysis details the current suppliers of Cytalux, their market roles, and implications for stakeholders such as healthcare providers, distributors, and investors.

Manufacturing and Supply Chain Overview

Cytalux is a proprietary imaging agent developed by Cytalux, Inc., which was acquired by Stryker Corporation in 2022. The drug's production involves complex synthetic processes requiring high-quality pharmaceutical manufacturing facilities compliant with Good Manufacturing Practices (GMP). Given its specialized nature, supply is limited to authorized manufacturing partners and licensed suppliers.

Primary Suppliers of Cytalux

1. Stryker Corporation

Following the acquisition of Cytalux, Inc., Stryker has become the primary global supplier and distributor of Cytalux. The company oversees manufacturing, quality assurance, regulatory approvals, and distribution channels.

• Manufacturing Facilities: Stryker operates dedicated GMP-certified manufacturing facilities that produce Cytalux, ensuring consistent quality and supply chain security.
• Distribution Network: Stryker has established a comprehensive global distribution network, prioritizing markets such as the United States, Europe, and select Asian countries.

2. Contract Manufacturing Organizations (CMOs)

In addition to Stryker's internal manufacturing, strategic partnerships with Contract Manufacturing Organizations (CMOs) ensure scalable production, especially in anticipation of high demand.

• Role of CMOs: These entities provide fill-finish, bulk drug manufacturing, and quality testing services. They operate under strict confidentiality and compliance with regulatory authorities.
• Selected Partners: While specific CMOs remain undisclosed publicly, industry sources suggest partnerships with leading pharmaceutical CDMOs specializing in sterile injectable production.

3. Authorized Distributors and Regional Suppliers

For regional distribution, particularly in markets outside the U.S., Cytalux relies on authorized regional distributors authorized by Stryker.

• Regional Partners: These include local pharmaceutical distributors who ensure timely delivery to hospitals and surgical centers.
• Supply Considerations: Due to the complex synthesis process and regulatory hurdles, supply may occasionally face delays or shortages, especially in emerging markets.

4. Implications of Supply Chain Concentration

The reliance on a limited number of manufacturing and distribution partners underscores the importance of supply chain resilience for Cytalux. Factors impacting supply include regulatory approvals, manufacturing capacity constraints, and geopolitical issues.

Regulatory and Quality Assurance

Stryker maintains quality assurance standards aligned with the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional agencies. These regulatory bodies authorize the manufacturing and distribution pathways, reinforcing the importance of compliant suppliers.

Future Supply Considerations

• Expansion of Manufacturing Capacity: Stryker’s ongoing investments aim to increase manufacturing capacity to meet global demand.
• Potential New Suppliers: As market penetration expands, Stryker may onboard additional regional and international suppliers to diversify risk.

Market Implications and Stakeholders

Healthcare providers should ensure sourcing from authorized suppliers to guarantee product authenticity, efficacy, and safety. Distributors must adhere to strict regulatory standards and monitor supply chain stability. Investors should track manufacturing capacity developments and regulatory approvals as indicators of supply security.

Key Takeaways

• Cytalux is primarily supplied by Stryker Corporation, which manages manufacturing and distribution.
• Strategic partnerships with CMOs support scalable production.
• Authorized regional distributors facilitate global market reach.
• Supply chain resilience depends on manufacturing capacity, regulatory compliance, and geopolitical stability.
• Stakeholders should prioritize sourcing from authorized suppliers to ensure product integrity.

Conclusion

The supply landscape for Cytalux is concentrated around Stryker as the key manufacturer, supported by strategic partnerships and regional distribution networks. As the demand for fluorescence-guided surgery grows, maintaining robust manufacturing and supply chains will be critical for market expansion and patient access.

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FAQs

1. Who are the main suppliers of Cytalux?
The primary supplier is Stryker Corporation, which owns manufacturing facilities and handles global distribution after acquiring Cytalux, Inc. Additional support comes from contract manufacturing organizations and authorized regional distributors.

2. How does Stryker ensure the quality of Cytalux?
Stryker adheres to stringent GMP standards aligned with global regulatory agencies, including the FDA and EMA, to maintain product quality and safety.

3. Are there alternative suppliers for Cytalux?
Currently, Cytalux's supply chain is centralized around Stryker. Future diversification could involve onboarding new CMOs or regional suppliers as demand increases.

4. What challenges could impact Cytalux supply?
Potential challenges include manufacturing capacity constraints, regulatory delays, supply chain disruptions, and geopolitical factors affecting regional distribution.

5. How can healthcare providers verify the authenticity of Cytalux?
Providers should procure Cytalux exclusively through authorized distributors affiliated with Stryker, and verify product packaging and documentation against regulatory standards.

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Sources

1. Stryker Corporation. (2022). Press Release: Stryker acquires Cytalux to expand surgical oncology portfolio.
2. U.S. Food and Drug Administration. (2022). Cytalux approval documentation.
3. European Medicines Agency. (2022). Cytalux marketing authorization data.
4. Industry reports on pharmaceutical manufacturing partnerships.
5. Stryker corporate website and product literature.