Last updated: May 25, 2026
ecutive summary
Restasis (cyclosporine ophthalmic emulsion 0.05%) is manufactured and supplied via a branded supply chain led by Bausch + Lomb (brand owner, commercial supply) and supported by third-party manufacturing for drug substance/drug product and distribution. Specific upstream suppliers (API makers and fill-finish sites) vary by year and lot, and supplier names are not consistently published in public sources. A complete, accurate “supplier list” by company for Restasis components is therefore not available from reliably citable public records in a way that supports business, licensing, or litigation use.
Who supplies Restasis (cyclosporine ophthalmic emulsion) ingredients and manufacturing?
Restasis is a topical ocular product in an emulsion formulation, which typically requires a dedicated ocular-grade manufacturing and packaging system. The public record more reliably identifies the brand sponsor and label manufacturer than it identifies all upstream suppliers of cyclosporine API, excipients, and the final emulsion fill-finish operator.
What companies are publicly tied to Restasis supply?
- Bausch + Lomb: U.S. brand sponsor and commercial owner for Restasis.
- Label/packaging and regulatory submissions can identify the listed manufacturer(s) of the finished dosage form for a given NDC strength and presentation, but those listed entities are not a comprehensive map of all ingredient suppliers.
Why supplier names are hard to pin down from public sources
- Restasis can be produced across multiple manufacturing sites over time.
- API and excipient supply chains can rotate by contract manufacturer and procurement cycle.
- Public databases often provide the finished dosage form manufacturer and limited details on upstream vendors.
What you can verify in public filings (highest-signal datapoints)
For Restasis, the most verifiable “supplier” items in public sources are:
- the FDA-label manufacturer (finished product)
- the NDC-labeled source for specific presentations
- the establishment identifiers associated with manufacturing (when shown in the record)
Which third-party manufacturers produce Restasis drug product and fill-finish?
Public-facing sources generally identify who makes the finished emulsion for a given labeled presentation rather than enumerating every fill-finish contractor for every batch.
What to expect in the Restasis manufacturing chain
A topical emulsion typically involves:
- emulsion preparation under controlled process parameters
- sterile or microbiologically controlled operations (as applicable to the product’s regulatory classification)
- container-closure compatibility work (single-use/packaging-specific)
- distribution and cold chain controls if used
How to map Restasis supply by NDC
Restasis has multiple NDCs tied to presentations. Supplier identification needs to be NDC-specific because label manufacturer(s) and pack configurations can change.
Do generic Restasis products have the same suppliers?
Generic and AB-rated cyclosporine ophthalmic emulsion products may use different:
- manufacturers for API
- excipient systems
- emulsion manufacturing sites
- sterile processing or fill-finish contractors
Even when the active ingredient is the same (cyclosporine), supplier ecosystems often differ.
What does FDA Orange Book say about Restasis manufacturing suppliers?
The Orange Book focuses on:
- active ingredient
- listed patents and exclusivity
- applicant/holder
It usually does not provide a complete list of upstream supplier companies for API and excipients. For “suppliers,” the highest-confidence public identifiers are those tied to the approved product application and label manufacturing site(s) rather than a procurement-style supplier roster.
What patent and exclusivity timeline affects Restasis manufacturing rights?
Restasis is an approved ophthalmic product; manufacturing rights for generic entry and for branded product manufacturing are governed by:
- regulatory approval status
- patent coverage
- potential exclusivity periods (if applicable to specific filing types)
Supplier selection is still a separate operational decision, commonly handled through contracting and qualification.
What competitive generic and biosimilar entry risks exist for Restasis suppliers?
There is no “biosimilar” framing for Restasis because it is a small-molecule ophthalmic emulsion. Competitive risks are tied to:
- generic entrants for cyclosporine ophthalmic emulsion 0.05%
- product comparability and facility qualification
- sustained supply and lot acceptance economics
What are the safest publicly supported “supplier” claims for Restasis in business use?
A defensible supplier statement for Restasis should be restricted to:
- Bausch + Lomb as brand owner and commercial supplier of record in the U.S.
- the FDA-listed manufacturer(s) for the finished dosage form shown for each NDC/presentation in the relevant FDA product listing/label record
A full upstream ingredient supplier list (API/excipients) is not reliably and consistently published in public sources in a way that supports a precise, supplier-by-supplier inventory.
Key Takeaways
- Restasis supply is reliably anchored to Bausch + Lomb as the brand owner/sponsor.
- Public records most consistently identify finished dosage form manufacturers rather than full upstream ingredient suppliers.
- A complete, accurate “suppliers for Restasis” roster by company is not available from reliably citable public information in a way suitable for licensing, litigation, or procurement decisions.
FAQs
- Who is the label/marketing authorization holder for Restasis in the U.S.?
- Which FDA-registered manufacturing site is listed for Restasis for a specific NDC?
- Do generic cyclosporine ophthalmic emulsion products source cyclospornine API from the same suppliers as Restasis?
- How can NDC-specific labeling be used to identify Restasis finished-product manufacturers?
- What public FDA documents best support the identification of Restasis drug product manufacturing entities?
References
- U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
- U.S. Food and Drug Administration. Drugs@FDA: Restasis (cyclosporine ophthalmic emulsion 0.05%).
