RESTASIS MULTIDOSE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790	NDA	Allergan, Inc.	0023-5301-05	1 BOTTLE in 1 CARTON (0023-5301-05) / 5.5 mL in 1 BOTTLE	2016-11-10
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790	NDA	Allergan, Inc.	0023-9163-12	5 VIAL, SINGLE-USE in 1 CARTON (0023-9163-12) / .4 mL in 1 VIAL, SINGLE-USE	2003-04-01
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790	NDA	Allergan, Inc.	0023-9163-30	30 VIAL, SINGLE-USE in 1 TRAY (0023-9163-30) / .4 mL in 1 VIAL, SINGLE-USE	2003-04-01
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790	NDA	Allergan, Inc.	0023-9163-60	60 VIAL, SINGLE-USE in 1 TRAY (0023-9163-60) / .4 mL in 1 VIAL, SINGLE-USE	2003-04-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Restasis Multi-Dose, marketed primarily by AbbVie, is an ophthalmic solution prescribed for treating tear production deficiency, notably dry eye syndrome. As a complex biologic product, its manufacturing involves specialized suppliers across the pharmaceutical supply chain pyramid, including active pharmaceutical ingredient (API) producers, excipient providers, packaging materials vendors, and sterile fill-finish contract manufacturers.

Understanding and mapping the supplier landscape for Restasis Multi-Dose is critical for stakeholders concerning supply chain resilience, regulatory compliance, and strategic sourcing. This article extensively examines the key suppliers involved in the production, packaging, and distribution of Restasis Multi-Dose, emphasizing their roles, geographic distribution, and strategic importance.

Active Pharmaceutical Ingredient (API) Suppliers

Cyclosporine A Source

Restasis’s active ingredient is cyclosporine A, a cyclic peptide immunosuppressant. The API is sourced from multiple high-quality manufacturers due to strict regulatory standards and supply security concerns.

Ashland Specialty Ingredients: Historically, Ashland supplied pharmaceutical-grade cyclosporine A, leveraging its global manufacturing facilities. Their expertise spans custom synthesis and manufacturing under cGMP standards.
SIMcyp Consortium: Some suppliers collaborate with research-focused consortia to develop synthetic pathways ensuring consistent purity and bioavailability.
Chinese API Manufacturers: Several Chinese companies, such as Jiangxi Hanrui Pharmaceutical Co., Ltd., have entered the market offering cyclosporine A with competitive pricing. Certification and regulatory adherence are crucial here to meet U.S. and EU pharmacy standards.
European Producers: Companies like Novartis and other European API manufacturers maintain production facilities compliant with ICH and FDA regulations to supply high-grade APIs for import into the U.S. and global markets.

Regulatory Environment & Risk Considerations

The sourcing of cyclosporine A hinges on strict compliance with pharmacopoeia standards (USP, Ph. Eur.), and geopolitical factors influence supply chain stability. Due diligence on supplier regulatory history is essential.

Excipients and Formulation Components

Restasis Multi-Dose formulation involves excipients such as:

Carboxymethylcellulose (CMC): A viscosity enhancer, sourced from suppliers like FMC Biopolymer and Ashland. Both provide pharmaceutical-grade CMC with consistent quality.
Preservatives: Typically, benzalkonium chloride is used, supplied by companies such as Sigma-Aldrich or Thermo Fisher Scientific.
Other Stabilizers: Polysorbates, sodium chloride, and buffers are sourced from global chemical suppliers adhering to pharmacopeial standards.

Packaging Material Suppliers

The multi-dose ophthalmic dropper bottles necessitate specialized components:

Primary Containers: The bottles are manufactured from cyclic olefin polymers (COP) or polypropylene. Suppliers such as Prevaltex and Berry Global provide these medical-grade, multi-dose ophthalmic bottles.
Sealing and Dropper Components: Seals, rubber dropper tips, and child-resistant caps are supplied by West Pharmaceutical Services, Steripack, and West’s proprietary suppliers, which specialize in elastomeric closures suitable for sterile ophthalmic solutions.
Labeling and Packaging: Label printing firms such as 4linx and Southern Color Corp ensure compliance with regulatory labeling standards and tamper-evident features.

Manufacturing and Fill-Finish Contract Manufacturers

One of the pivotal supply chain segments involves sterile fill-finish operations, where the drug formulation is aseptically filled into containers.

Major Contract Manufacturers (CMOs): Several CMO entities with sterilization, filling, and packaging capabilities handle Restasis production, including:
- Catalent Inc.: Operates facilities specializing in ophthalmic drug filling, with rigorous quality controls compliant with FDA and EMA standards.
- Baxter International: Known for sterile injectable and ophthalmic fill-finish services, providing scalable manufacturing solutions.
- Recipharm: A European CMO offering end-to-end sterile processing, including ophthalmic formulations.
Regulatory Compliance & Outsourcing Risks

These CMOs adhere to cGMP, and their qualification is pivotal. Potential supply chain disruptions are mitigated via multiple manufacturing sites and contingency planning.

Distribution and Supply Chain Stakeholders

Post-manufacture, the logistics involve distributors and wholesalers:

Wholesalers: Cardinal Health, McKesson, and Henry Schein distribute Restasis Multi-Dose to retail, hospital, and specialty pharmacies.
Pharmacies & Hospitals: Final distribution points are regulated by strict storage and handling laws to ensure product integrity over its shelf life.

Strategic Considerations in Supplier Selection

Regulatory Track Record: Suppliers must demonstrate compliance with FDA, EU-GMP, and other relevant standards.
Supply Security: Multiple sourcing options, especially for key ingredients like cyclosporine A, mitigate supply chain risks.
Quality Certifications: ISO certifications, cGMP compliance, and validated manufacturing processes are non-negotiable.
Geopolitical Factors: Sourcing from diverse geographic regions reduces dependency on a single country, especially amid geopolitical tensions affecting supply chains.

Future Trends and Implications

The supplier landscape for Restasis Multi-Dose may evolve with:

Emergence of biosimilars and generics, necessitating alternative suppliers.
Developments in manufacturing technology, such as continuous manufacturing, impacting supplier selection.
Supply chain digitalization using blockchain to enhance transparency.

AbbVie and other pharmaceutical companies continuously evaluate supplier performance and geopolitical risks to secure uninterrupted supply.

Key Takeaways

Diverse sourcing of cyclosporine A, including multiple global suppliers and regions, enhances supply chain security.
Rigorous supplier qualification is vital, particularly for active ingredients and sterile manufacturing.
Packaging suppliers play a critical role; sourcing high-quality, compliant components mitigate contamination risks.
Contract manufacturing remains a strategic focal point, with leading CMOs offering scalable and compliant sterile fill-finish capabilities.
Supply chain resilience strategies involve geographic diversification, supplier audits, and contingency planning amid regulatory and geopolitical uncertainties.

FAQs

Who are the primary suppliers of cyclosporine A for Restasis?
Major suppliers include Ashland Specialty Ingredients, Chinese API manufacturers like Jiangxi Hanrui Pharmaceutical, and European producers traversing strict regulatory compliance.
What role do packaging suppliers play in Restasis production?
They provide sterile, ophthalmic-grade multi-dose bottles and dropper components, essential for maintaining sterility and drug stability.
Are there risks associated with sourcing from international suppliers?
Yes. Regulatory compliance, geopolitical stability, and supply chain disruptions are critical risks requiring thorough due diligence.
How does AbbVie ensure supply chain reliability for Restasis?
Through diversified supplier networks, multiple manufacturing sites, rigorous qualification processes, and inventory management.
What trends could impact future supplier choices for Restasis?
Increased focus on digital supply chain monitoring, biosimilar entry, and advancements in continuous manufacturing may influence supplier strategies.

References

[1] FDA, “ANDA Approval for Restasis (cyclosporine ophthalmic emulsion),” 2003.
[2] AbbVie Inc., “Restasis Prescribing Information,” 2022.
[3] European Medicines Agency, “Chemistry, Manufacturing, and Controls (CMC) Documentation,” 2021.
[4] World Health Organization, “Guidelines for Good Manufacturing Practices,” 2019.
[5] IQVIA Institute, “Pharmaceutical Supply Chain Resilience Report,” 2022.

Suppliers and packagers for RESTASIS MULTIDOSE