Last updated: April 25, 2026
LUZU (luliconazole) is a branded antifungal drug (topical). The supplier landscape depends on whether “suppliers” means (1) the branded product holder/marketer, (2) the drug substance (API) manufacturers, (3) the finished-dosage manufacturers, or (4) contract packaging and distribution.
If “suppliers” means the branded product marketer in the US, the supply is tied to the NDA/label-holder and its distributors.
Who is the LUZU marketer and label holder in the US?
LUZU is marketed in the US under the NDA/label by Bausch Health US, LLC (LUZU label is held under the Bausch Health umbrella). The label identifies the US distributor/marketer information. (See LUZU prescribing information.) [1]
US label holder / marketer
| Item |
Entity |
| US label holder / marketer for LUZU |
Bausch Health US, LLC |
What company manufactures the finished dosage form?
The prescribing information identifies manufacturing and packaging sites via “Manufactured for” / “Distributed by” sections. Those sections determine the finished-dose manufacturer and packaging sites for the commercial product. (See LUZU prescribing information.) [1]
Who supplies the active pharmaceutical ingredient (API) for luliconazole?
API suppliers are typically disclosed in:
- Drug Master Files (DMFs) and regulatory filings tied to the NDA, or
- Public extractable listings in regulatory databases and inspection records,
- Batch-specific manufacturing disclosures in label/manufacturing sections.
For LUZU specifically, the public prescribing label is the definitive starting point for identifying finished product manufacturing/packaging responsibility; API supplier names are not consistently printed on the label.
What about generic or AB-rated versions of luliconazole?
Where generics exist, API and finished-dose sourcing can differ by ANDA filer and contract manufacturing arrangements. The practical investor view is to track:
- ANDA/ANDA applicant,
- API DMF referenced in the ANDA,
- Finished dosage and packaging sites listed in the ANDA (when publicly available),
- Lot-level sourcing where the label or traceability disclosures allow.
(Here, the key constraint is that “supplier” without a scope (API vs finished product vs distributor) cannot be mapped to a single list from the public label alone.)
What is the most reliable supplier map you can build from public data?
Use the LUZU label’s manufacturing and distribution statements for finished product sourcing and the NDA holder for branded market supply. That produces a defensible “supplier map” for commercial execution.
| Supplier type |
Source to use |
What you can state from label |
| Branded marketer / label holder |
Prescribing information |
Bausch Health US, LLC |
| Finished dosage manufacturing and/or packaging |
Prescribing information “Manufactured for” / “Packaged by” sections |
Manufacturer/packager named on the label |
| API supplier |
DMF/ANDA regulatory trail |
Not fully enumerated on the label in most cases |
Key Takeaways
- Bausch Health US, LLC is the US marketer/label holder for LUZU (luliconazole). [1]
- The finished product manufacturer and packaging entities are identified in the LUZU prescribing information via manufacturing/distribution sections. [1]
- API (luliconazole) supplier names are typically not fully listed in the branded label; the credible public path is through NDA/DMF/ANDA referenced filings and traceability artifacts.
FAQs
-
Is Bausch Health the supplier of LUZU in the US?
Bausch Health US, LLC is the label holder/marketer for LUZU. [1]
-
Where can I find the finished product manufacturer for LUZU?
The LUZU prescribing information lists the manufacturer/packager in the “Manufactured for” and distribution sections. [1]
-
Can I identify the luliconazole API supplier from the LUZU label alone?
The branded label typically focuses on finished product manufacturing/distribution; API supplier names are often not stated on the label. [1]
-
Do generic luliconazole products use the same suppliers as LUZU?
Often not. Generics may use different ANDA applicants, API DMFs, and contract manufacturing sites.
-
What is the fastest way to build a supplier list for LUZU operations?
Start with the LUZU prescribing information for marketer and finished dose manufacturing/packaging, then expand to regulatory filings for API sourcing.
References
[1] Bausch Health US, LLC. LUZU (luliconazole) prescribing information.
