Last updated: May 25, 2026
Executive summary: Lifitegrast ophthalmic products rely on a limited set of upstream API and specialty ophthalmic-formulation supply chains. In practice, supply is concentrated around (1) lifitegrast (API) producers, and (2) contract manufacturing organizations (CMOs) that can handle high-containment solids, sterile/aseptic ophthalmic drug product, and low-volume stability programs. The supplier map also depends on the specific dosage strength and presentation (commonly single-dose units for ophthalmic use) and whether the product is made for the innovator or an authorized generic licensee.
What suppliers provide lifitegrast API for ophthalmic products?
Lifitegrast is the active ingredient used in prescription ophthalmic therapy for dry eye disease. Supplier relationships are typically split between API manufacture and sterile ophthalmic filling.
How do lifitegrast API sourcing patterns typically work?
- API is generally supplied as a controlled bulk intermediate/bulk API with defined polymorph and particle-size specs suitable for ophthalmic suspension/solution formulation.
- Ophthalmic drug product manufacturing requires compatibility with preservative systems, pH targets, and sterilization or aseptic processing approach.
Which companies supply lifitegrast API?
This section cannot be completed with complete accuracy from the provided input because it requires a verified supplier list (company names tied to lifitegrast API manufacturing) sourced from authoritative records such as FDA DMFs, Orange Book/Drug Master Files linkages, inspection databases, or supplier disclosures in product filings. Without that complete sourcing evidence, a supplier roster would risk being wrong.
Which contract manufacturers make lifitegrast ophthalmic drug product (sterile filling, aseptic processing)?
Lifitegrast ophthalmic drug product manufacturing is typically split across specialized sterile processing and packaging.
What production steps constrain lifitegrast CMO selection?
- Sterile drug product manufacturing (aseptic processing and sterile filtration, or validated sterilization approach if applicable).
- Container-closure compatibility for ophthalmic use.
- Single-dose unit packaging validation, including leak, dose uniformity, and extractables.
- Stability and in-use testing for ophthalmic administration systems.
How many CMO options exist for lifitegrast?
The supply base is usually narrow because ophthalmic sterile CMO capacity is concentrated and because lifitegrast submissions require data alignment to regulatory expectations for the specific formulation and container.
This section cannot be completed with a validated count of CMOs and their names without authoritative manufacturing attribution records tied to lifitegrast presentations.
Who are the branded product makers and label-holders for lifitegrast in the U.S.?
In the U.S., product-labeling and regulatory ownership generally map to the NDA holder and authorized distributors. Supplier questions for “who makes it” often differ from “who owns the marketing authorization.”
This section requires the specific U.S. product NDC(s) and the current labeler/holder, which is not provided in the prompt. Without those, listing label-holders would risk misidentification.
What is the Orange Book status of lifitegrast and how does it affect supplier contracting?
Orange Book listings tie to the NDA and its patent estate, and they can influence:
- CMO willingness to support generic/authorized generic versions,
- tech-transfer scope, and
- defensibility of manufacturing know-how.
A precise Orange Book status and listing set cannot be produced from the provided input alone.
What generic entry risks and authorized generic pathways affect lifitegrast supply?
Supplier behavior changes when:
- Paragraph IV litigation is active,
- settlements grant specific launch windows or manufacturing restrictions, and
- authorized generics share manufacturing sites.
No Orange Book, litigation, or settlement details were provided, so this cannot be built accurately.
What manufacturing barriers exist for lifitegrast (API to sterile ophthalmic drug product)?
The main barriers for lifitegrast supply chains usually include:
- API quality: polymorph/form control, impurity profile, and batch reproducibility.
- Formulation constraints: pH, chelation/solubilization balance, preservative system selection, and stability.
- Sterility assurance: aseptic processing discipline and validated sterilizing filtration compatibility (if applicable).
- Packaging: single-dose ophthalmic containment and extractables/leachables.
A defensible, drug-specific barrier analysis still requires formulation and manufacturing process specifics that are not included in the prompt.
Lifitegrast supplier map by supply chain node (API vs drug product vs packaging)
Table: Lifitegrast supplier map (required fields not provided)
| Supply chain node |
What to identify |
Verified evidence needed |
| API |
Lifitegrast API manufacturer(s) and DMF(s) |
FDA DMF linkages, inspectional/filing disclosures |
| Drug product (sterile) |
CMO/processor for sterile filling/aseptic processing |
NDA supplement manufacturing site list |
| Packaging |
Primary/secondary packaging vendors and container-closure system |
CMC module disclosures |
| Release testing |
QC sites and release lab responsibilities |
CMC/QP and batch release documentation |
No verified company-level supplier data is included in the input, so populating this table would fail the accuracy constraint.
Key takeaways
- Lifitegrast supply is structured around a constrained ophthalmic sterile manufacturing pipeline plus controlled lifitegrast API sourcing.
- Building a correct, company-specific supplier list requires product-specific regulatory and CMC evidence that is not present in the prompt.
- Without validated Orange Book/NDA labeling and DMF/manufacturing attribution, naming suppliers would be unreliable.
FAQs
- Who is the NDA holder for lifitegrast ophthalmic products in the U.S.?
- Which FDA DMFs reference lifitegrast API and what do they list as manufacturing sites?
- What sterile manufacturing processes (aseptic vs sterilized filtration) are used for lifitegrast drug product?
- Are there authorized generic or generic versions of lifitegrast that change CMO utilization?
- What formulation and packaging constraints affect lifitegrast CMO qualification for ophthalmic use?
