Drug
Who makes aminolevulinic acid hydrochloride?
3 companies list aminolevulinic acid hydrochloride as a human prescription drug, including under the names AMELUZ, GLEOLAN, LEVULAN KERASTICK. Forms: gel; kit; powder, for solution. Routes: oral, topical.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing aminolevulinic acid hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | kit | NDANDA020965 | 1 | 13 |
| Biofrontera Bioscience GmbHGermany | gel | NDANDA208081 | 1 | 1 |
| NX DEVELOPMENT CORP | powder, for solution | NDANDA208630 | 1 | 0 |
Orange Book patents
13 unexpired patents list aminolevulinic acid hydrochloride as the active ingredient, expiring between Feb 2028 and Dec 2043. Application holders: BIOFRONTERA INC, SUN PHARMACEUTICAL INDUSTRIES INC.
Enquiry
Common questions
- Who makes aminolevulinic acid hydrochloride?
- 3 companies list aminolevulinic acid hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Biofrontera Bioscience GmbH, NX DEVELOPMENT CORP. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.