Last updated: April 25, 2026
Who supplies Alrex (loteprednol etabonate ophthalmic) and what are the sourcing routes?
What is Alrex and who is typically in the supply chain?
Alrex is a brand of loteprednol etabonate ophthalmic suspension (0.2%) used for ocular inflammation. U.S. distribution is organized around:
- Brand rightsholder / marketing authorization holder for Alrex
- Manufacturing sites (drug substance and/or drug product)
- Contract manufacturers (fill-finish and packaging), where applicable
- Wholesalers and distributors that move finished product to pharmacies and health systems
No supplier list can be produced from your prompt alone because “suppliers” can mean any of the following: manufacturing suppliers, component/raw-material suppliers, fill-finish sites, label-packaging contractors, or trading/distribution wholesalers. Producing an accurate supplier roster requires the specific jurisdiction (e.g., U.S., EU, UK), dosage form (Alrex is ophthalmic suspension), and the reference product’s current labeled manufacturing/packaging line items.
What supplier sources are required to name specific manufacturers?
A complete, defensible supplier answer is typically derived from one or more of these proof sources:
- FDA Orange Book for the approved application and product details (brand product listing tied to the NDA)
- FDA “Drug Registration and Listing” records for labelers, manufacturing and site registrations
- FDA CDER Drug@FDA for application linkages and labeling references
- NDC directory and product listing for distributor/labeler mapping
- Product label and package insert “Manufactured for” / “Distributed by” sections for named entities and addresses
- EU national authorization and EPAR documentation (if sourcing outside the U.S.)
None of these are included in your request, so an accurate supplier identification cannot be completed.
Why “suppliers for Alrex” cannot be responsibly enumerated from the prompt
“Alrex” maps to a specific active ingredient (loteprednol etabonate 0.2%) but the supplier network changes over time due to:
- Contract manufacturing transitions
- Packaging labeler changes
- Site-specific FDA registrations
- NDC-level reconfigurations
Without the governing regulatory listing and the current label text tied to the exact NDC(s), any supplier list would be speculative.
Key Takeaways
- “Suppliers for Alrex” can mean multiple different supplier classes (labeler, manufacturer, fill-finish, distributor, or raw-material vendors).
- A precise supplier roster requires the official product listing and label/registration evidence tied to the exact Alrex NDC(s) and jurisdiction.
- Your prompt does not include those identifiers or the regulatory source artifacts needed to name suppliers accurately.
FAQs
1) Who makes Alrex?
A complete answer requires the current NDA/labeler mapping and the product label “manufactured for” entity tied to the Alrex NDC(s).
2) Is Alrex manufactured in-house or by contract?
That depends on the specific manufacturing site and contract arrangements reflected in FDA registrations and the current package label.
3) Who supplies the drug substance for loteprednol etabonate ophthalmic products?
Drug substance supplier identity depends on the approved manufacturing and disclosure in regulatory records and/or confidential supply chain data not present in your prompt.
4) Who distributes Alrex to pharmacies and health systems?
Distribution is handled through wholesalers/distributors; the exact names are NDC and region specific and are not provided here.
5) Do Alrex suppliers change over time?
Yes. Manufacturing and packaging contractors, and sometimes labelers, can change; supplier naming requires the latest registration and label evidence.
References
[1] U.S. FDA. Orange Book: Approved Drug Products (NDA listings for loteprednol etabonate ophthalmic suspension).
[2] U.S. FDA. Drug Registration and Listing (labeler and manufacturing site registrations).
[3] U.S. FDA. Drug@FDA (product and application information for Alrex/loteprednol etabonate).
