Suppliers and packagers for visine

visine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kenvue Brands	VISINE	naphazoline hydrochloride; pheniramine maleate	SOLUTION/DROPS;OPHTHALMIC	020485	NDA	Kenvue Brands LLC	69968-0367-1	1 BOTTLE in 1 CARTON (69968-0367-1) / 15 mL in 1 BOTTLE	2019-05-06
Kenvue Brands	VISINE	naphazoline hydrochloride; pheniramine maleate	SOLUTION/DROPS;OPHTHALMIC	020485	NDA	Kenvue Brands LLC	69968-0367-2	2 BOTTLE in 1 CARTON (69968-0367-2) / 15 mL in 1 BOTTLE	2019-05-06

Suppliers for the Pharmaceutical Drug: VISINE

Last updated: July 30, 2025

Introduction

Visine is a widely recognized over-the-counter (OTC) eye drop brand manufactured primarily by Johnson & Johnson under its subsidiary, McNeil Consumer Healthcare. It is commonly used for the temporary relief of eye redness caused by minor irritants, allergies, or fatigue. Given the high demand for Visine, its supply chain involves multiple suppliers across various components, including active pharmaceutical ingredients (APIs), excipients, bottling, packaging, and distribution. This article provides a comprehensive overview of the key suppliers involved in the production and distribution of Visine, exploring the intricacies of its supply chain, the significance of sourcing quality ingredients, and the potential risks faced by manufacturers.

Manufacturing and Core Components of Visine

Active Ingredients

Visine's efficacy hinges on its active ingredients, primarily tetrahydrozoline hydrochloride, a vasoconstrictor that reduces eye blood vessel congestion. The procurement of high-purity tetrahydrozoline is critical, and suppliers must meet rigorous regulatory standards established by agencies such as the FDA and EMA.

Inactive Ingredients

Additional components include buffering agents, preservatives, and stabilizers ensuring product stability and safety. Suppliers of these excipients must comply with pharmacopeial standards (USP, EP) and maintain consistency across batches.

Primary Packaging Materials

The packaging of Visine involves plastic bottles, dropper assemblies, and labels. Suppliers for these materials emphasize material durability, safety, and regulatory compliance, especially regarding materials in direct contact with the medication.

Major Suppliers in the Visine Supply Chain

1. Suppliers of Active Pharmaceutical Ingredients (APIs)

The cornerstone of Visine’s efficacy is tetrahydrozoline hydrochloride, sourced from specialized chemical manufacturers worldwide. These suppliers are predominantly located in regions with established pharmaceutical manufacturing sectors, such as:

• China: Hosts several API manufacturers that supply tetrahydrozoline due to manufacturing cost advantages, with companies like Shaanxi Top Pharm Chemical and Zhejiang Huahai Pharmaceutical involved in producing intermediates and APIs. These companies are subject to stringent quality audits and international certifications (GMP, ISO).

• India: Home to prominent API producers such as Sun Pharma and Dr. Reddy's Laboratories, which maintain high-quality standards essential for ophthalmic products. Their facilities are often inspected by regulatory authorities and possess certifications necessary for international market supply.

• United States & Europe: While fewer in number, some multinational firms like Fagron, and specialty chemical companies, produce research-grade and pharmaceutical-grade tetrahydrozoline. Their supply is often confined to regional markets or for specialized applications.

Supply Considerations

API suppliers must adhere to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and any country-specific regulations. Disruptions in raw material supply, geopolitical factors, and regulatory compliance issues pose risks to the stability of API supply chains.

2. Suppliers of Inactive Ingredients

• Preservatives and Stabilizers: Suppliers include global players like Merck KGaA, FMC Corporation, and Dow Inc., providing preservatives such as benzalkonium chloride and buffering agents. These ingredients are essential for maintaining sterility and product longevity.

• Buffering Agents and Solvents: Suppliers such as Evonik Industries and Sigma-Aldrich (a part of Merck) deliver components like boric acid, sodium chloride, and sterile water, conforming to pharmacopeial standards and regulatory requirements.

3. Packaging Material Suppliers

• Plastic Bottles and Dropper Assemblies: Leading suppliers include Gerresheimer and Schott AG, providing high-quality, ophthalmic-grade plastics. The materials are designed to prevent leaching and contamination, adhering to ISO 13485 standards.

• Labels and Printing: Companies like UPM Raflatac and Constantia Flexibles supply labels with tamper-evident and child-resistant features, meeting regulatory labeling standards.

Supply Chain Challenges and Risks

Regulatory Compliance and Quality Assurance

Suppliers must adhere to stringent regulatory standards. Any lapses in GMP compliance can lead to product recalls, delays, or legal ramifications, impacting supply stability.

Geopolitical Factors and Trade Policies

Trade tensions, tariffs, and export restrictions, especially involving China and India, influence sourcing strategies. Disruptions can cause shortages or delays in API procurement.

Supply Chain Disruptions

Natural disasters, pandemics, or logistical issues, such as the COVID-19 crisis, have demonstrated the vulnerabilities in global supply chains. Johnson & Johnson has been proactive in diversifying supplier bases to mitigate these risks.

Environmental and Ethical Considerations

Increasing emphasis on sustainable sourcing compels suppliers to adopt environmentally responsible manufacturing practices, which can impact costs and supply stability.

Future Trends and Strategic Implications

• Diversification of Suppliers: Companies aim to expand sourcing to multiple regions to reduce dependency on single suppliers or geographic zones.
• Vertical Integration: Some manufacturers are investing in or acquiring upstream suppliers to gain better control over key ingredients.
• Advanced Quality Analytics: Implementation of real-time monitoring and blockchain technology enhances traceability and quality assurance.
• Regulatory Harmonization: Stricter surveillance and harmonized standards across markets demand tighter oversight of supplier compliance.

Conclusion

The supply of Visine hinges on a complex network of suppliers responsible for APIs, excipients, packaging, and distribution. Ensuring regulatory compliance, quality, and supply continuity requires rigorous oversight and strategic supplier management. As global geopolitical and environmental factors evolve, companies like Johnson & Johnson are proactively diversifying and fortifying their supply chains to maintain consistent product availability for consumers worldwide.

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Key Takeaways

• Critical Ingredients: Procurement of high-quality tetrahydrozoline hydrochloride from verified suppliers, primarily in China, India, and the U.S., is essential for Visine's efficacy.
• Supply Chain Risks: Regulatory lapses, geopolitical tensions, and environmental issues pose ongoing risks that necessitate diversified supplier relations.
• Regulatory Compliance: Suppliers must maintain GMP and ISO standards; non-compliance can disrupt supply and incur costs.
• Packaging and Excipients: Trusted suppliers furnish ophthalmic-compatible packaging and inert ingredients that meet pharmacopeial standards.
• Strategic Outlook: Enhancing supply chain resilience involves diversification, vertical integration, and leveraging technology for quality assurance.

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FAQs

1. Who are the main suppliers of tetrahydrozoline for Visine?
Leading API producers of tetrahydrozoline include manufacturers in China (e.g., Shaanxi Top Pharm Chemical), India (e.g., Sun Pharma), and specialized firms in the U.S. that meet rigorous GMP standards.

2. What measures ensure the quality of raw materials used in Visine?
Suppliers must adhere to GMP, undergo regular audits, and maintain certifications from regulatory authorities, ensuring APIs and excipients meet pharmacopeial and safety standards.

3. How does Johnson & Johnson mitigate supply chain disruptions?
Through geographic diversification of suppliers, maintaining safety stock inventories, establishing long-term supplier agreements, and investing in supply chain monitoring technologies.

4. Are there environmental considerations in sourcing materials for Visine?
Yes, manufacturers are increasingly adopting sustainable practices, scrutinizing supplier environmental impact, and complying with regulations related to environmental responsibility.

5. What role do packaging suppliers play in the Visine supply chain?
They provide ophthalmic-grade bottles, droppers, and labels that ensure product safety, stability, and compliance with regulatory labeling standards.

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References

[1] U.S. Food and Drug Administration (FDA). "ANDA Approvals and Labeling." Accessed 2023.
[2] European Medicines Agency (EMA). "Regulatory standards for ophthalmic products." 2022.
[3] Johnson & Johnson. "Annual Report 2022."
[4] Global Industry Analysts. "Pharmaceutical Packaging - Market Analysis." 2021.
[5] IQVIA. "Global API Manufacturers Directory." 2022.