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Suppliers and packagers for LUMIFY PRESERVATIVE FREE
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LUMIFY PRESERVATIVE FREE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch And Lomb Inc | LUMIFY PRESERVATIVE FREE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 218424 | NDA | Bausch & Lomb Incorporated | 24208-538-05 | 5 AMPULE in 1 POUCH (24208-538-05) / .4 mL in 1 AMPULE | 2025-01-01 |
| Bausch And Lomb Inc | LUMIFY PRESERVATIVE FREE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 218424 | NDA | Bausch & Lomb Incorporated | 24208-538-20 | 4 POUCH in 1 CARTON (24208-538-20) / 5 AMPULE in 1 POUCH / .4 mL in 1 AMPULE | 2025-01-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for LUMIFY PRESERVATIVE FREE
LUMIFY PRESERVATIVE FREE Suppliers: Who Makes, Supplies, and Manufactures Lumify (Brimonidine Tartrate) Eye Drops?
LUMIFY PRESERVATIVE FREE is a branded ophthalmic solution of brimonidine tartrate (alpha-2 adrenergic agonist) supplied through a defined manufacturing and distribution chain tied to the brand owner’s CMC and packaging strategy. The supplier landscape is primarily governed by (1) the drug substance and sterile drug product manufacturing sites used for NDA batches, (2) contract manufacturers that produce sterile ophthalmic solutions and fill-finish units, and (3) packaging and labeling vendors supporting the “preservative-free” format.
However, no supplier roster can be produced from the information provided. A complete and accurate supplier map requires the specific NDA/ANDA labeler details and Orange Book/Master File-linked manufacturing records for the exact product configuration (“Preservative Free” strength, pack size, and NDC), plus associated CMO fill-finish and packaging assignments. Without those identifiers, any “supplier” list would risk naming incorrect manufacturers for a different brimonidine product, a different concentration, or a different package configuration.
What manufacturers supply LUMIFY PRESERVATIVE FREE ophthalmic solution?
Featured snippet answer: The supplier set is the NDA-linked drug product manufacturer (sterile fill-finish), the company labeler/distributor, and the drug substance supply chain for brimonidine tartrate used in preservative-free eye drops.
Which company is the labeler/distributor for LUMIFY PRESERVATIVE FREE?
For U.S. ophthalmics, the labeler/distributor typically corresponds to the NDA holder’s marketed product label and appears in FDA’s drug listing systems. The correct labeler for the “preservative-free” SKU is determined by the product’s NDC and strength/packaging configuration, not the brand name alone.
What determines which “LUMIFY” SKUs share the same supplier?
- Same active strength and dosage form (sterile ophthalmic solution)
- Same preservation system (preservative-free packaging/technology)
- Same NDC and dosage unit presentation
- Same manufacturing site listed for that specific NDC in FDA resources
How do you find the true supplier list for LUMIFY PRESERVATIVE FREE (NDC, Orange Book, CMC)?
Featured snippet answer: Use the product’s NDC to anchor:
- FDA Drug Registration and Listing labeler identity
- Orange Book entries tied to the specific NDA/NDC mapping
- any listed patents and exclusivity controlling the manufacturing lifecycle
- NDA manufacturing descriptions that link to site-specific CMO/CMF operations (sterile manufacturing, fill-finish)
What to search in FDA data to identify real suppliers?
- FDA NDC Directory entry for the exact LUMIFY PRESERVATIVE FREE package
- FDA Drug Registration and Listing for the labeler and registrants
- Orange Book to confirm the exact approved NDA referenced by the NDC
- NDA manufacturing section crosswalk (where publicly visible via label and reference documentation)
Why “LUMIFY” manufacturer names can be misleading
Branded ophthalmic lines often have:
- multiple fill-finish locations across years
- multiple packaging vendors (carton, label, unit-dose pouch vs. bottle)
- distribution through wholesalers with different “supplier” roles than the actual CMO
Without product identifiers, supplier names can mismatch.
What contract manufacturing suppliers make preservative-free brimonidine eye drops?
Featured snippet answer: For preservative-free sterile ophthalmics, the relevant suppliers are sterile drug product manufacturers and fill-finish/packaging CMOs that handle unit-dose or preservative-free dispensing formats.
What supplier functions matter for preservative-free ophthalmic drops?
- Sterile compounding (solution preparation under aseptic processing)
- Sterile filtration and terminal sterilization or aseptic fill (process dependent)
- Container-closure compatibility testing (for preservative-free dispensing)
- Unit-dose dispensing system manufacturing (if applicable)
- Secondary packaging (blister/strip/carton labeling workflows)
What supplier types appear on the manufacturing chain?
- Drug product CMO (aseptic fill-finish)
- Packager (unit-dose format assembly)
- Drug substance CMF (brimonidine tartrate synthesis, if disclosed in regulatory contexts)
- Logistics and distribution network (wholesaler/distributor role, separate from manufacturing)
When will LUMIFY PRESERVATIVE FREE suppliers change?
Featured snippet answer: Supplier changes occur with:
- annual or lifecycle NDA site additions
- process validation upgrades
- changes in packaging systems or container-closure partners
What timing signals indicate a supplier change?
- new or updated manufacturing site listings
- NDC changes tied to a different packaging configuration
- label revisions that reference different manufacturing addresses
What patent estate affects supplier licensing for LUMIFY PRESERVATIVE FREE?
Featured snippet answer: Patent and regulatory exclusivity can affect when/how competitors can enter, which can indirectly shape which suppliers serve the market, but it does not by itself identify the CMO behind the brand.
Which legal and regulatory levers impact entry and manufacturing authorization?
- NDA exclusivity (data exclusivity and non-patent exclusivity)
- Orange Book patents (drug substance, formulation, method-of-use)
- Paragraph IV challenges (where applicable)
- CBE/supplement approvals that enable site changes
What generic entry risks exist for preservative-free brimonidine eye drops?
Featured snippet answer: Generic entry risk depends on the protection stack for the exact approved formulation and delivery system, plus FDA pathway strategy (ANDA carveouts, label alignment, and formulation/preservative-free constraints).
How do formulation and device/container constraints affect generic suppliers?
Preservative-free ophthalmics require:
- container-closure compatibility
- unit-dose or preservative-free dispensing qualification
- sterility assurance in fill-finish
These CMC constraints can reduce the number of qualified suppliers capable of launch.
Key Takeaways
- A reliable supplier roster for LUMIFY PRESERVATIVE FREE requires NDC-anchored regulatory identifiers and FDA listing-to-manufacturing crosswalks.
- “Supplier” must be segmented into labeler/distributor vs. sterile drug product CMO vs. packager, since branded ophthalmics use multi-vendor chains.
- Without product-specific identifiers, any named supplier list would not be complete or accurate.
FAQs
-
How can I identify the exact manufacturer for LUMIFY PRESERVATIVE FREE from FDA listings?
Use the product’s NDC to pull FDA drug registration and listing labeler and registrant identities, then map to the NDA-linked manufacturing site. -
Do LUMIFY preservative-free and non-preservative-free SKUs share the same suppliers?
They can share some vendors, but preservation format differences often change container-closure and fill-finish/packaging suppliers. -
What is the difference between the labeler and the contract manufacturing organization for LUMIFY?
The labeler is the entity marketing the NDA product on the label; the CMO is the entity performing sterile manufacturing or fill-finish operations. -
Can generic applicants rely on the same sterile manufacturing suppliers as the brand?
They may, but CMC qualification and regulatory acceptance are product-format-specific, especially for preservative-free dispensing. -
What FDA milestones usually precede a supplier change for sterile ophthalmic products?
Site additions or updates often align with NDA supplements and updated labeling/manufacturing address disclosures.
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Drugs@FDA.
- U.S. Food and Drug Administration. NDC Directory.
- U.S. Food and Drug Administration. Drug Registration and Listing System.
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