Last updated: May 27, 2026
Xiidra (lifitegrast ophthalmic solution 5%) is supplied through a defined contract manufacturing and packaging network for the commercial eye-drop product. The supplier set is best sourced from (1) FDA label “Manufactured for”/“Distributed by” lines, (2) Orange Book/Master File-linked CMC identifiers, and (3) inspection-linked manufacturing sites on FDA databases. Without these source lines for the specific NDA/strength/packaging and the current label version, a complete, supplier-specific list cannot be produced accurately.
Who supplies Xiidra drug product (ophthalmic solution 5%)?
Featured snippet answer: Xiidra’s commercial drug product is marketed and distributed under the branded label by the NDA holder’s commercial organization, and manufactured by one or more contract manufacturers listed on the FDA-approved prescribing information “Manufactured for” and “Distributed by” sections.
What does the FDA label show about the manufacturer/distributor?
- “Manufactured for” line: identifies the commercial labeler and the manufacturer entity responsible for final drug-product release.
- “Distributed by” line: identifies the distributor entity for sales logistics.
- Packaging configuration: bottle size, single-use units, and carton labeling can map to distinct packaging sites.
Which contract manufacturers make Xiidra?
The contract manufacturing and packaging entities cannot be enumerated without the current FDA label manufacturer/distributor lines for the marketed SKU and strength.
What is the active ingredient (lifitegrast) supplier chain?
Featured snippet answer: The lifitegrast API supply is traced through FDA-referenced Drug Master Files (DMFs) and CMC section cross-references, then mapped to the NDA holder’s quality agreements and commercial supply contracts.
How API suppliers are identified for lifitegrast
- API DMFs: API suppliers are often named indirectly through DMF holders referenced by the NDA.
- CMC filings: the NDA’s manufacturing section lists API and drug-product manufacturing site details.
- Inspection history: manufacturing sites are confirmed via FDA establishment listings and inspection assignments.
Which API manufacturers supply lifitegrast to Xiidra?
A supplier list cannot be produced accurately without the DMF/CMC-linked identifiers tied to the NDA for lifitegrast 5% ophthalmic solution.
What packaging suppliers exist for Xiidra eye drops?
Featured snippet answer: Xiidra has primary container-closure systems and secondary packaging under contract packaging operations; the actual packaging suppliers are indicated on the label/packaging insert and sometimes by FDA establishment registrations.
Which components define “packaging suppliers”
- Primary container: ophthalmic bottle or single-use unit system.
- Closure system: dropper and cap components.
- Sterile fill-finish and packaging lines: often different sites than API and drug-product.
How do you map packaging suppliers to FDA records?
- FDA establishment registries: identify packaging and repacking sites for the drug.
- Label imprint and NDC: map to specific package configurations and thus to specific packaging runs.
How does NDC-specific labeling affect supplier identification?
Supplier identity can change by NDC even for the same strength if there is a packaging-site transition or a bottle/container change.
What suppliers support sterile manufacturing for Xiidra?
Featured snippet answer: Xiidra is an ophthalmic solution requiring sterile manufacturing controls and fill-finish under GMP, typically handled by specialized sterile drug-product manufacturers.
Which manufacturing steps drive supplier selection
- Sterile filtration and aseptic processing (as applicable)
- Container closure integrity controls
- Sterility assurance and environmental monitoring
- Visual inspection and labeling reconciliation
How many fill-finish suppliers exist for Xiidra?
The number depends on commercial redundancy and historical site utilization. A count cannot be stated without label- and establishment-level site mapping for current commercial supply.
What does the competitive landscape imply for Xiidra suppliers?
Featured snippet answer: Xiidra’s supplier network can be influenced by market demand stability, contract manufacturing capacity for sterile ophthalmics, and regulatory inspection outcomes.
How do competitors change supplier availability?
- Generic or alternative formulations typically use their own supply chains.
- Contract manufacturing capacity for ophthalmic sterile fill-finish is often shared across multiple ophthalmic products, causing supplier allocation shifts.
Do Xiidra generics or alternatives share the same suppliers?
That depends on whether alternative products use the same CMOs and API suppliers. A cross-product supplier map cannot be created here without product-by-product label/manufacturer evidence.
What is the Orange Book status of Xiidra suppliers?
Featured snippet answer: The Orange Book lists patents for Xiidra and includes NDA data, but it does not itself provide a complete supplier list. Supplier identity is taken from label manufacturing/distribution lines and CMC and DMF linkages.
How Orange Book data supports supplier mapping
- NDA reference
- Applicant/labeler identity
- Patent landscape context that can indirectly indicate CMC linkages
Do Orange Book entries list manufacturing sites?
Not directly in a way that yields a reliable supplier roster.
Key Takeaways
- A reliable supplier list for Xiidra requires label-source manufacturer/distributor lines and NDA/DMF or establishment mappings.
- Without the current FDA label manufacturer/distributor text and the NDA-linked DMF/CMC identifiers, a complete and accurate list of lifitegrast API suppliers, sterile fill-finish CMOs, and packaging suppliers cannot be produced.
- Supplier identity can vary by NDC/package configuration, so SKU-specific sourcing is necessary for defensible procurement or diligence.
FAQs
1) Who is the labeled manufacturer of Xiidra on the prescribing information?
Adefensible answer requires the current FDA label “Manufactured for” line for the exact NDC/package configuration.
2) Where can I find the lifitegrast API supplier for Xiidra?
API suppliers are identified via FDA DMF/CMS linkages referenced by the Xiidra NDA and confirmed by establishment records, not by the Orange Book alone.
3) Which contract manufacturers provide sterile fill-finish for lifitegrast 5% ophthalmic solution?
This is determined by the current label and FDA establishment listings for the specific drug-product NDC.
4) Are packaging suppliers the same across all Xiidra NDCs?
Often not. Packaging sites and container-closure configurations can differ across SKUs.
5) Does Xiidra’s patent status determine its suppliers?
No. Patent status affects market exclusivity and potential generic entry, not the manufacturing/packaging vendor roster directly.
References (APA)
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration.
- FDA. (n.d.). NDC Directory. U.S. Food and Drug Administration.
- FDA. (n.d.). National Drug Code Directory and labeling information. U.S. Food and Drug Administration.
