zerviate: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694	NDA	Harrow Eye, LLC	82667-015-24	1 POUCH in 1 CARTON (82667-015-24) / 30 VIAL, SINGLE-USE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-USE	2025-04-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Zerviate is a prescription ophthalmic solution containing cetirizine, an antihistamine used primarily to treat allergic conjunctivitis. Approved by the U.S. Food and Drug Administration (FDA) in December 2020, Zerviate offers a targeted approach to managing ocular allergy symptoms. As with any pharmaceutical product, the supply chain hinges on reliable sourcing of active pharmaceutical ingredients (APIs), excipients, and finished dosage forms. This article provides a comprehensive overview of the main suppliers involved in the Zerviate supply chain, focusing on key players, regional manufacturing hubs, and strategic considerations vital for stakeholders assessing the drug's sourcing landscape.

Composition and Manufacturing Profile of Zerviate

Zerviate's primary component, cetirizine, is a second-generation antihistamine, traditionally available in oral formulations. Its ophthalmic formulation requires specialized excipients and a sterile manufacturing environment. The drug is produced by Ista Pharmaceuticals, a wholly owned subsidiary of Alcon Inc., a global leader in eye care. The manufacturing process involves sourcing high-quality APIs, ophthalmic-grade excipients, and sterile filling technologies, all governed by stringent regulatory standards (e.g., cGMP compliance).

Key Suppliers for the Active Ingredient (Cetirizine)

The cornerstone of Zerviate’s supply chain resides in API sourcing—cetirizine. Historically, cetirizine is synthesized through multistep chemical processes, with most bulk APIs produced in regions with established pharmaceutical manufacturing capacities.

Major API Manufacturers

Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
A prominent producer of antihistamines and other pharmacological APIs, Zhejiang Huahai supplies cetirizine to numerous pharmaceutical firms globally. Robust manufacturing capacity, coupled with competitive pricing and compliance with international standards, positions it as a key player in cetirizine supply.
Aurobindo Pharma (India)
A leading Indian generic manufacturer, Aurobindo produces cetirizine as part of its extensive API portfolio. It holds multiple global certifications, including US FDA approval for its manufacturing facilities, ensuring a reliable supply chain.
Torrent Pharmaceuticals (India)
Torrent is among the top API suppliers for antihistamines, with stringent quality controls and a sizeable manufacturing footprint supporting global demand.
Mitsubishi Tanabe Pharma Corporation (Japan)
While primarily known for research and development, Mitsubishi Tanabe also supplies high-quality APIs. For regulated markets, reputation and compliance are critical; thus, Japanese manufacturers often serve niche or high-value segments.

Emerging API Suppliers

Sino Biopharmaceutical Limited (China)
Engaged in biosimilars and small-molecule APIs, Sino Biopharmaceutical is expanding its offerings in antihistamine APIs, including cetirizine.
Li & Fung (Hong Kong)
A sourcing and distribution firm that manages supply chains and procurement for API intermediates across Asia, including cetirizine.

Excipients and Formulation Components

Creating ophthalmic solutions like Zerviate demands specific excipients ensuring sterility, pH stability, and safety. Key excipient suppliers include:

BASF SE (Germany)
Supplies ophthalmic-grade solvents, stabilizers, and buffering agents.
Ashland Global Holdings (USA)
Provides preservatives and unique stabilizers compatible with ophthalmic formulations.
Dow Chemical Company (USA)
Supplies sterile aqueous solutions and polymers for contact lens compatibility.

Manufacturers of Finished Zerviate Product

The final manufacturing step involves sterile filling, packaging, and quality control. Alcon Inc., the marketer of Zerviate, operates several manufacturing facilities worldwide, including in the United States, Switzerland, and Ireland.

Key Contract Manufacturing Organizations (CMOs) and Fill-Finish Partners

Pharmaceutics International, Inc. (USA)
Known for sterile filling and lyophilization, supporting ophthalmic injectables and solutions.
Patheon (a part of Thermo Fisher Scientific, USA)
Specializes in sterile ophthalmic manufacturing, ensuring compliance with regulatory norms.
Alcon’s Internal Manufacturing Facilities
Alcon maintains in-house cGMP-compliant manufacturing plants to ensure control over quality, with production situated in the U.S. and Europe.

Regional Supply Chain Dynamics

The geographic distribution of suppliers influences risk management, lead times, and compliance considerations. Asian manufacturers dominate API supply owing to cost advantages and established infrastructure, notably in China and India. Conversely, North American and European manufacturers offer high regulatory compliance standards, essential for regulatory submissions in these markets.

Risks and Contingencies

Supply Disruptions: Geopolitical tensions, pandemic-related restrictions, or natural disasters could impact API and excipient supplies. Diversification among multiple suppliers minimizes risks.
Regulatory Changes: Evolving standards, like stricter manufacturing audits or import/export controls, can affect sourcing and cost.
Quality Assurance: Suppliers must meet pharmacopeial standards (USP, EP, JP) and comply with cGMP regulations to prevent delays or market withdrawals.

Strategic Considerations for Stakeholders

Vertical Integration: Given the importance of consistent API supply, companies involved in Zerviate's lifecycle might consider partnering with multiple API suppliers to safeguard against shortages.
Regulatory Transparency: Suppliers with transparent quality management systems and comprehensive documentation assist regulatory approval and batch consistency.
Cost versus Reliability: While Asian APIs often offer lower costs, European and North American suppliers might provide higher assurance of quality, influencing procurement strategies.

Conclusion

The supply chain for Zerviate encompasses a network of specialized API producers, excipient suppliers, and finished product manufacturers, with key roles played by Chinese and Indian API firms alongside U.S. and European manufacturers. Ensuring a resilient, compliant, and high-quality supply chain requires strategic sourcing, frequent quality audits, and risk mitigation practices. Continuous evaluation of geopolitical and regulatory landscapes remains critical for stakeholders seeking security in Zerviate’s supply chain.

Key Takeaways

Primary API sourcing for Zerviate’s cetirizine predominantly involves Chinese and Indian manufacturers with capacity for large-scale production.
Quality certifications and compliance with international standards are non-negotiable for API and excipient suppliers.
Manufacturing domestically and internationally enables supply chain resilience but necessitates rigorous quality oversight.
Regulatory dynamics influence supplier choices, especially for markets with strict pharmacopeia requirements.
Strategic diversification of suppliers minimizes supply disruptions, ensuring consistent availability of Zerviate.

FAQs

1. Who are the main API suppliers for cetirizine used in Zerviate?
The leading API suppliers include Zhejiang Huahai Pharma (China), Aurobindo Pharma, and Torrent Pharmaceuticals (India). These manufacturers provide high-quality cetirizine conforming to international standards.

2. How does supply chain risk affect Zerviate production?
Supply chain disruptions can lead to manufacturing delays or shortages. Reliance on regional API producers means geopolitical or health crises (like COVID-19) could impact supply continuity.

3. Are there alternative sources for cetirizine API in case of shortages?
Yes, other manufacturers like Mitsubishi Tanabe Pharma Japan and Sino Biopharmaceutical are potential alternatives, although transitioning requires regulatory validation and quality assessments.

4. What role do excipient suppliers play in Zerviate manufacturing?
Excipients are vital for formulation stability and safety; suppliers such as BASF and Ashland ensure supply of ophthalmic-grade excipients compliant with pharmacopeial standards.

5. How does the manufacturing location influence the supply chain security of Zerviate?
Manufacturing in regions with robust regulatory oversight (U.S., Europe, Japan) provides high compliance assurance, whereas Asian manufacturing offers cost benefits but requires rigorous quality assurance measures.

Sources

[1] U.S. Food and Drug Administration (FDA). "Zerviate (cetirizine ophthalmic solution) approval information." 2020.
[2] Zhejiang Huahai Pharmaceutical Co., Ltd. Corporate website. “API manufacturing overview.”
[3] Aurobindo Pharma Limited. “API product portfolio and certifications.”
[4] Alcon Inc. Corporate website. “Manufacturing facilities and quality standards.”
[5] Pharmaceutics International Inc. Overview of sterile manufacturing capabilities.

Suppliers and packagers for zerviate

zerviate

Suppliers for the Pharmaceutical Drug: Zerviate