Suppliers and packagers for verkazia

verkazia

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965	NDA	Santen Incorporated	65086-001-05	1 POUCH in 1 CARTON (65086-001-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE	2022-02-01
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965	NDA	Santen Incorporated	65086-001-12	24 POUCH in 1 CARTON (65086-001-12) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE	2022-02-01

Suppliers for the Pharmaceutical Drug: VERKAZIA

Last updated: July 31, 2025

Introduction

Verkazia (loteprednol etabonate ophthalmic suspension 0.25%) has secured its place among key treatments for ocular inflammatory conditions. As an engineered corticosteroid, its unique formulation offers effective relief with a favorable safety profile. Understanding the supplier landscape for Verkazia is crucial for stakeholders involved in procurement, supply chain management, and strategic planning within pharmaceutical distribution channels.

Overview of Verkazia

Developed by Eyevance Pharmaceuticals, Verkazia is designated primarily for the treatment of allergic conjunctivitis in pediatric and adult patients. Its approval by regulatory authorities like the FDA exemplifies a meticulously tailored supply chain, encompassing raw material sourcing, manufacturing, and distribution partners. Ensuring supply continuity involves multiple key suppliers across various stages of the product lifecycle.

Manufacturing and Raw Material Suppliers

Loteprednol Etabonate Active Pharmaceutical Ingredient (API)

The core component of Verkazia, loteprednol etabonate, derives from a complex synthesis pathway requiring high purity, stability, and stringent regulatory compliance.

• Generic API Suppliers:
  While Eyevance Pharmaceuticals developed the proprietary formulation, the active pharmaceutical ingredient is often sourced from specialized chemical synthesis companies. Leading providers include Siegfried AG and Piramal Pharma Solutions, known for high-quality corticosteroid APIs with global GMP certifications.

• Custom Synthesis Providers:
  Some formulations may utilize contracted custom synthesis organizations (CSOs), catering to specific chemical specifications and supply demands. These include Vogel GmbH and Bachem.

Excipients and Formulation Components

• Suspension Vehicles:
  Polymers like hyaluronic acid or xanthan gum used as stabilizers and viscosity agents are supplied by firms such as Ashland Global Holdings and FMC Corporation. Their excipients meet pharmacopeial standards, ensuring compatibility with ocular tissues.

• Preservatives:
  Benzalkonium chloride, often utilized as a preservative, is sourced from Merck KGaA or Neogen Corporation.

Manufacturing Facilities and Contract Manufacturers (CMOs)

Eyevance Pharmaceuticals primarily operates manufacturing facilities in the United States, with potential contract manufacturing arrangements globally.

• In-House Manufacturing:
  Their facilities are equipped with sterile compounding and filling lines compliant with FDA cGMP standards, ensuring quality and supply security.

• Contract Manufacturers:
  The company may leverage CMOs like Catalent, Althea, or Recipharm for certain production steps, including packaging and final suspension formulation.

Distribution and Supply Chain Partners

• Global Distributors:
  Major pharmaceutical distribution networks such as McKesson, AmerisourceBBergen, and Cardinal Health serve as primary channels for Verkazia's distribution across the U.S. and international markets.

• Regional Distributors:
  Regional or specialty ophthalmic distributors facilitate access to ophthalmologists and clinics, ensuring timely supply for outpatient care.

Regulatory and Certification Influence on Supply

Suppliers and manufacturers must hold valid GMP certification from regulatory authorities like the FDA (U.S.) or EMA (Europe). These certifications indicate adherence to high-quality manufacturing standards, critical for ophthalmic drugs where contamination risks are significant.

Supply Chain Challenges and Considerations

• Raw Material Sourcing:
  The complexity of corticosteroid API synthesis and strict regulatory standards can lead to supply shortages if demand spikes or raw material shortages occur.

• Manufacturing Capacity:
  As a specialized ophthalmic product, Verkazia’s manufacturing capacity may be limited to specific facilities, risking temporary shortages if demand exceeds supply.

• Global Market Dynamics:
  Export regulations, patent protections, and regional regulatory differences influence the geographic scope and supplier engagements.

Key Suppliers Summary Table

Component	Major Suppliers	Role	Certification & Certification Bodies
API (Loteprednol Etabonate)	Siegfried AG, Piramal Pharma Solutions	Raw material	GMP (FDA, EMA)
Excipients	Ashland, FMC Corporation	Formulation components	pharmacopeial standards
Preservatives	Merck KGaA, Neogen Corporation	Stability agents	pharmacopeial standards
Manufacturing Facilities	Eyevance in-house, CMOs like Catalent	Production and filling	cGMP (FDA, EMA)
Distributors	McKesson, AmerisourceBergen, Cardinal Health	Distribution	Valid licensing and compliance

Emerging Trends in Supply Chain for Ophthalmic Drugs

• Vertical Integration:
  Manufacturers seek to control more supply chain segments, reducing dependency risks.

• Global Sourcing:
  Diversifying raw material supply sources, especially for key APIs, remains a strategic priority.

• Digital Supply Chain Management:
  Implementation of advanced tracking and inventory management systems enhances visibility and responsiveness.

Conclusion

The supply chain for Verkazia involves complex networks of raw material suppliers, contract manufacturers, and distributors operating under strict regulatory frameworks. Ensuring supply continuity hinges on high-quality API sourcing, robust manufacturing capabilities, and strategic distribution partnerships grounded in compliance and quality assurance.

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Key Takeaways

• Multiple high-quality suppliers are critical for Verkazia’s production, including API manufacturers like Siegfried AG and Piramal.
• Regulatory compliance (GMP, cGMP) remains the cornerstone for supplier reliability and product safety.
• Manufacturing capacity and raw material availability directly impact supply stability, particularly during demand surges.
• Global distribution networks ensure broad market access but require ongoing logistical and regulatory alignment.
• Investing in supply chain resilience and diversification reduces risks and enhances long-term product availability.

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FAQs

1. Who are the primary API suppliers for Verkazia?
Primarily, API components are sourced from established pharmaceutical synthesis companies such as Siegfried AG and Piramal Pharma Solutions, both maintaining GMP-certified production.

2. Are there alternative suppliers for Verkazia’s excipients?
Yes. Leading excipient suppliers like Ashland and FMC provide pharmacopeial-grade components essential for suspension stability and safety.

3. Does Eyevance Pharmaceuticals own the manufacturing facilities for Verkazia?
They operate in-house manufacturing in the U.S. but also collaborate with Contract Manufacturing Organizations (CMOs) to optimize capacity and compliance.

4. How does regulatory compliance affect the supplier landscape?
Certifications like GMP are mandatory, ensuring suppliers adhere to strict quality standards critical for ophthalmic drugs like Verkazia.

5. What are the main risks in Verkazia’s supply chain?
Risks include raw material shortages, manufacturing delays, logistical disruptions, and regulatory changes impacting international supply and distribution.

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Sources

[1] FDA Approval Documentation for Verkazia.
[2] Eyevance Pharmaceuticals Supply Chain Overview.
[3] Global API Market Reports (Siegfried AG, Piramal Pharma).
[4] Pharmacopeial Standards for Ophthalmic Excipients.
[5] Pharmaceutical Supply Chain Management Best Practices.