Drug
Who makes azelaic acid?
8 companies list azelaic acid as a human prescription drug, including under the names AZELEX, FINACEA FOAM. Forms: aerosol, foam; cream; gel. Routes: cutaneous, 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 azelaic acid
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | gel | ANDAANDA210549 | 1 | 13 |
| Glenmark Pharmaceuticals Inc., USAIndia | gel | ANDAANDA204637 | 1 | 9 |
| Encube Ethicals LimitedIndia | gel | ANDAANDA208724 | 1 | 5 |
| Sandoz Industrial Products S.AAustria | gel | NDA AUTHORIZED GENERICNDA021470 | 1 | 5 |
| LEO Pharma A/SIreland | aerosol, foam | NDANDA207071 | 1 | 3 |
| Actavis LLCUnited States | gel | ANDAANDA208011 | 1 | 1 |
| Bryant Ranch PrepackUnited States | gel | ANDAANDA208724 | 1 | 1 |
| Almirall, LLC | cream | NDANDA020428 | 1 | 0 |
Bulk ingredient listings
- Alivus Life Sciences Limited · 2 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- Darmerica, LLCUnited States · 1 NDC
- Flamma USA LLCItaly · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Siegfried PharmaChemikalien Minden Gmbh · 1 NDC
- TYCHE INDUSTRIES LIMITEDIndia · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
Orange Book patents
4 unexpired patents list azelaic acid as the active ingredient, expiring between Sept 2027 and Feb 2029. Application holder: LEO PHARMA AS.
Enquiry
Common questions
- Who makes azelaic acid?
- 8 companies list azelaic acid as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Glenmark Pharmaceuticals Inc., USA, Encube Ethicals Limited, Sandoz Industrial Products S.A, LEO Pharma A/S. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic AZELEX?
- 5 companies list azelaic acid under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies azelaic acid active ingredient?
- 8 companies list azelaic acid as a bulk ingredient, including Alivus Life Sciences Limited, Professional Compounding Centers of America dba PCCA, Darmerica, LLC, Flamma USA LLC.