Prescription drug
Where is Azelaic Acid made?
8 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 5 factories in India, Canada, Switzerland and Italy.
India 2Canada 1Switzerland 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.0.15 g per 1 g · NDC 51672-1389 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Encube Ethicals, Inc.0.15 g per 1 g · NDC 21922-038 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Glenmark Pharmaceuticals Inc., USA0.15 g per 1 g · NDC 68462-626 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Intendis Inc. Finacea0.15 g per 1 g · NDC 10922-825, 10922-826 | Intendis Manufacturing SPAMakes it | Location not on file | Not inspected on record |
| LEO Pharma Inc. Finacea Foam.15 g per 1 g · NDC 50222-303 | Asm Aerosol-Service AgMakes it | Möhlin, Switzerland | Problems found, fixed voluntarilyNov 2023 |
| Sandoz Inc.0.15 g per 1 g · NDC 0781-7172 | Leo Pharma Manufacturing Italy SRL.Makes it | Segrate, Italy | Problems found, fixed voluntarilyNov 2023 |
| Actavis Pharma, Inc.0.15 g per 1 g · NDC 0591-2131 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Aqua Pharmaceuticals, LLC Azelex0.2 g per 1 g · NDC 16110-869 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Azelaic Acid in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-3032 - Bryant Ranch Prepack:
72162-2297 - Physicians Total Care, Inc.:
54868-5236,54868-4442
Recalls
- Jul 23, 2026 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. - Sep 17, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Market complaints received for gritty texture (grainy) - Jul 22, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.