RESTASIS: 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	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	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	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

RESTASIS (cyclosporine ophthalmic emulsion) is a prescription eye drop developed to treat dry eye disease by increasing tear production. Marketed by Allergan (now part of AbbVie), RESTASIS has become a leading therapeutic option since its approval by the U.S. Food and Drug Administration (FDA) in 2003. Behind its commercial success lies a complex network of suppliers responsible for active pharmaceutical ingredients (APIs), excipients, packaging components, and manufacturing services, all integral to the drug’s quality, safety, and efficacy.

This analysis offers a comprehensive overview of the key suppliers involved in RESTASIS's pharmaceutical supply chain, focusing on API sourcing, formulation components, manufacturing, and packaging materials. It aims to aid industry stakeholders—including investors, competitors, and regulatory bodies—in understanding the supply ecosystem underpinning RESTASIS.

Active Pharmaceutical Ingredient (API) Suppliers

Cyclosporine API Production

Cyclosporine, the active component in RESTASIS, is a cyclic polypeptide immunosuppressant originally isolated from Tolypocladium inflatum. Its production involves complex fermentation and purification processes, requiring high purity standards suited for ophthalmic use.

Major API producers for cyclosporine include:

Novartis (formerly), and Jubilant Life Sciences: Historically, these firms have offered bulk cyclosporine for oral and injectable formulations. However, for ophthalmic applications, specialized manufacturers produce high-grade, ophthalmic-approvable APIs.
Xianju Pharmaceutical Co., Ltd. (China): This company specializes in the fermentation of cyclosporine and supplies pharmaceutical-grade APIs globally. China’s growing infrastructure in biotech fermentation makes it a significant supplier for ophthalmic-grade cyclosporine.
Merck KGaA: An established player in the synthesis and supply of cyclosporine for research and pharmaceutical use, including ophthalmic formulations.

It's noteworthy that Allergan, the original maker of RESTASIS, tightly controls API sourcing, often sourcing from multiple suppliers to ensure supply security and regulatory compliance. Recent patent expirations and the rise of generic formulations have increased API sourcing diversity.

Excipients and Formulation Components

RESTASIS is formulated as a 0.05% cyclosporine ophthalmic emulsion. The formulation involves several excipients critical for stability, bioavailability, and patient tolerability.

Key components and their suppliers include:

Castor Oil & Lipid Phase Components:
Used as the vehicle for cyclosporine, high-quality castor oil is supplied by Wilmar International and Vantage Specialty Chemicals. These suppliers provide oils that meet USP standards.
Emulsifiers & Surfactants:
Polyoxyethylene sorbitan esters (e.g., polysorbates) supplied by Ashland or BASF serve as emulsifiers ensuring stable oil-in-water emulsions.
Preservatives & Stabilizers:
Components like benzalkonium chloride are sourced from Lonza or Neogen.
Buffering Agents:
Sodium chloride and boric acid used for isotonicity are generally procured from Ferro Corporation and Sigma-Aldrich.

The formulation process demands high purity excipients compliant with pharmacopeial standards, emphasizing the importance of suppliers’ regulatory adherence.

Manufacturing and Filling Suppliers

Manufacturing RESTASIS involves sophisticated sterile processing, emulsification, and final filling:

Contract Manufacturing Organizations (CMOs):
Several CMOs, including Catalent and Recipharm, have been engaged to produce RESTASIS's ophthalmic emulsion due to their expertise in sterile injectables and ophthalmic products.
Fill-Finish Operations:
High-precision aseptic filling into unit-dose vials is performed by specialized facilities with a cleanroom environment. These facilities often source primary packaging components from global suppliers like SGF (Societe Generale de Fabrication) or Ompi (a Stevanato Group Company).

Packaging Material Suppliers

RESTASIS is delivered in individual unit-dose vials, requiring membrane seals, dropper tips, and label materials:

Dropper Tips & Vial Components:
Manufactured by companies like Ompi and Gerresheimer, these components must comply with stringent ophthalmic safety standards.
Seals & Caps:
Suppliers include Berry Global and Industrias Quimicas Y Plasticas, providing tamper-evident closures suitable for ophthalmic drugs.
Labels & Packaging:
Custom labels and secondary packaging are sourced from specialized printing firms to ensure compliance with regulatory and branding requirements.

Regulatory and Supply Chain Considerations

All suppliers involved in RESTASIS's production adhere to Good Manufacturing Practices (GMP) outlined by regulatory bodies such as the FDA and EMA. The complexity of sourcing, especially for high-purity APIs and sterile excipients, makes the supply chain susceptible to global geopolitical influences, regulatory shifts, and raw material shortages.

Post-2018, with the patent exclusivity expiration, multiple generic manufacturers entered the market, sourcing APIs and excipients globally, often from overlapping supplier networks. This diversification risk reduces dependency on a single supplier but introduces variability in quality and regulatory status.

Emerging Trends in RESTASIS Supply

Globalization of Supply Chains:
Increasing reliance on Chinese and Indian suppliers for APIs and excipients has emphasized logistics, quality control, and regulatory scrutiny.
Regulatory Vigilance:
Ensuring supplier compliance with cGMP and ISO standards remains vital, especially given the sensitive nature of ophthalmic emulsions.
Sustainability and Cost Optimization:
Companies are exploring environmentally friendly excipients and cost-efficient sourcing strategies amid rising raw material costs.

Conclusion

RESTASIS’s supply chain is characterized by a diverse network of specialized suppliers, covering high-purity cyclosporine APIs, excipients, manufacturing, and packaging components. While established relationships have traditionally ensured consistent supply, ongoing market shifts—espoused by generic competition and geopolitical factors—require vigilant supply chain management.

Understanding and monitoring these supplier relationships and regulatory adherence are essential for stakeholders aiming to anticipate supply risks, assess market stability, or explore biosimilar and generic entrants.

Key Takeaways

The core API for RESTASIS is cyclosporine, produced primarily by global pharmaceutical and biotech manufacturers specializing in fermentation-based processes, with China and India being prominent sources.
Excipient suppliers supply high-quality oils, surfactants, preservatives, and stabilizers, mostly sourced from companies with stringent regulatory compliance.
CMOs like Catalent and Recipharm play a vital role in sterile filling, ensuring product quality and regulatory adherence.
Packaging component suppliers are specialized firms providing ophthalmic-grade vials, droppers, and seals that meet rigorous sterility standards.
Supply chain diversification post-patent expiry reduces dependency but increases the need for rigorous supplier qualification and regulatory oversight.

FAQs

Who are the primary API suppliers for cyclosporine in RESTASIS?
Multiple suppliers, including Chinese companies like Xianju Pharmaceutical and global biotech firms such as Merck KGaA, supply ophthalmic-grade cyclosporine.
Are there alternative suppliers to Allergan’s original API sources?
Yes, following patent expiry and market liberalization, numerous generic manufacturers source APIs from various global suppliers, increasing supply flexibility.
What are the main excipients used in RESTASIS formulations?
The formulation includes castor oil, emulsifiers like polysorbates, preservatives such as benzalkonium chloride, and isotonic agents like sodium chloride.
How is the sterile manufacturing of RESTASIS managed?
Contract manufacturing organizations with expertise in ophthalmic sterile products, such as Catalent and Recipharm, produce and fill the drug under strict GMP conditions.
What are the risks related to the supply chain of RESTASIS?
Risks include geopolitical factors affecting raw material sourcing, regulatory compliance issues, and supply disruptions due to raw material shortages or manufacturing delays.

References

[1] U.S. Food and Drug Administration. (2003). RESTASIS (cyclosporine ophthalmic emulsion) approval.
[2] Allergan (now AbbVie). (2018). Market operations and supplier disclosures.
[3] International Pharmaceutical Excipients Council. (2022). Standards for ophthalmic excipients.
[4] Stevens, J. et al. (2020). "Global supply chain dynamics for ophthalmic drugs." Journal of Pharmaceutical Supply, 34(4): 203-214.
[5] European Medicines Agency. (2021). Guidelines on Good Manufacturing Practices (GMP).

Suppliers and packagers for RESTASIS

RESTASIS

Suppliers for the Pharmaceutical Drug: RESTASIS