Last updated: April 26, 2026
Prolensa is the brand name for bromfenac ophthalmic solution (NSAID). In the US, the branded product is marketed by Bausch + Lomb Incorporated. Manufacturing and supply are handled via Bausch + Lomb’s commercial supply chain and contract manufacturing network for ophthalmic sterile products.
Which company is the labeled supplier for Prolensa in the US?
Bausch + Lomb Incorporated is the labeler (the company responsible for the product as marketed in the US) for Prolensa.
Labeler and product identity (US)
| Item |
Detail |
| Brand |
Prolensa |
| Active ingredient |
Bromfenac (ophthalmic NSAID) |
| Labeler (US) |
Bausch + Lomb Incorporated |
| Dosage form |
Ophthalmic solution |
Source: FDA’s National Drug Code (NDC) directory for Prolensa and the branded product listing tied to the labeler Bausch + Lomb Incorporated. [1]
Who manufactures Prolensa (contract or owned facilities)?
For ophthalmic sterile solutions like Prolensa, the manufacturer of record is reflected in the NDC “manufacturer” field for each strength and package configuration. Those manufacturer names track the commercial supply chain tied to each NDC listing and can change over time as production is moved among approved sites.
How to interpret “supplier” vs “labeler”
- Labeler: the firm marketing the drug under the approved brand.
- Manufacturer: the firm operating the approved manufacturing site(s) for the specific NDC presentations.
Practical implication for procurement and due diligence: use the exact Prolensa NDC (strength and package) to identify the manufacturer-of-record for that specific SKU and then map it to the underlying sterile manufacturing site(s) and regulatory inspection history.
Sources: FDA NDC directory distinguishes labeler and manufacturer fields by NDC for marketed drug presentations. [1]
What does the supply chain look like for Prolensa?
Prolensa’s supply chain is typical for sterile ophthalmic products:
- Commercial labeler/distributor: Bausch + Lomb (US marketing and supply responsibility as labeler). [1]
- Approved manufacturer-of-record: listed by NDC in FDA’s NDC directory (may vary by strength and package). [1]
- Regulatory oversight: manufacturing sites appear in FDA inspection databases (site-level oversight) and product-level oversight via NDC-linked listings.
Which strengths and presentations drive different supplier mapping?
Supplier identification for procurement is NDC-dependent. Each Prolensa strength and package configuration can map to different manufacturer entries in the FDA NDC database.
Data requirement for exact supplier mapping
To lock supplier names precisely, you must match procurement to:
- Brand name: Prolensa
- Strength
- Pack size
- NDC for that SKU
Then read the manufacturer entry in the FDA NDC listing.
Source: FDA NDC directory is the authoritative index for labeler and manufacturer by NDC presentation. [1]
Key compliance signals that matter for “supplier” selection
When you assess supplier risk or qualify alternate supply, focus on:
- NDC manufacturer-of-record (for the exact SKU)
- Sterile ophthalmic manufacturing capability (sterile process and quality system)
- CGMP compliance history for the specific manufacturing site linked to the NDC presentation
Source: FDA’s NDC directory provides manufacturer-of-record linkage by NDC. [1]
Key Takeaways
- Bausch + Lomb Incorporated is the US labeler for Prolensa (bromfenac ophthalmic solution). [1]
- The actual manufacturing supplier(s) depend on the NDC presentation (strength and package), because FDA lists the manufacturer-of-record separately from the labeler by NDC. [1]
- For procurement-grade supplier identification, the actionable method is NDC-to-manufacturer mapping using the FDA NDC directory. [1]
FAQs
-
Is Bausch + Lomb the manufacturer of Prolensa?
Bausch + Lomb is the labeler. The manufacturer-of-record is determined by the NDC presentation in FDA’s NDC directory. [1]
-
Where do I find the manufacturer name for the exact Prolensa SKU?
In the FDA NDC directory for that Prolensa strength and pack, where the manufacturer field is listed for the specific NDC. [1]
-
Can Prolensa have multiple manufacturing suppliers?
Yes. For branded sterile products, manufacturer-of-record can vary by NDC presentation and over time. FDA’s NDC directory is the reference for the current mapping. [1]
-
Does “labeler” equal “supplier” in procurement documents?
Not necessarily. “Labeler” is marketing responsibility; “manufacturer” is the approved manufacturing entity for the specific NDC presentation. [1]
-
What’s the fastest way to validate supplier mapping for Prolensa?
Match the exact NDC to the FDA NDC directory entry and use the listed manufacturer for that SKU. [1]
References
[1] U.S. Food and Drug Administration. (n.d.). NDC Directory (Prolensa/bromfenac ophthalmic solution; labeler and manufacturer fields by NDC). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
