Drug
Who makes isotretinoin?
14 companies list isotretinoin as a human prescription drug, including under the names Absorica, Absorica LD, ACCUTANE, Amnesteem, Claravis, ZENATANE. Forms: capsule; capsule, gelatin coated; capsule, liquid filled. Routes: oral.
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 isotretinoin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | capsule | NDA, NDA AUTHORIZED GENERICNDA021951, NDA211913 | 16 | 13 |
| Zydus Lifesciences LimitedIndia | capsule | ANDAANDA211568, ANDA216633 | 10 | 12 |
| Zydus Pharmaceuticals USA Inc.India | capsule | ANDAANDA211568, ANDA216633 | 10 | 1 |
| Aurobindo Pharma LimitedIndia | capsule | ANDAANDA218194, ANDA220336 | 9 | 6 |
| Mayne Pharma International Pty Ltd.Australia | capsule, liquid filled | ANDAANDA076485, ANDA212333, ANDA213571 | 8 | 1 |
| Upsher-Smith Laboratories, Inc. | capsule, liquid filled | ANDAANDA076485, ANDA212333, ANDA213571 | 8 | 0 |
| Actavis LLCUnited States | capsule | ANDAANDA205063 | 6 | 1 |
| Amneal Pharmaceuticals NY LLC | capsule | ANDAANDA216097 | 6 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | capsule, gelatin coated | ANDAANDA202099 | 4 | 15 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule, liquid filled | ANDAANDA076135, ANDA076356 | 4 | 6 |
| Amneal Ireland LimitedIreland | capsule, liquid filled | ANDAANDA207792 | 4 | 1 |
| BluePoint Laboratories Inc. | capsule, gelatin coated | ANDAANDA202099 | 4 | 0 |
| JG Pharma Inc. | capsule, gelatin coated | ANDAANDA202099 | 4 | 0 |
| Mylan Pharmaceuticals, Inc. | capsule | ANDAANDA075945 | 4 | 0 |
Bulk ingredient listings
- Chongqing Huapont Pharmaceutical Co LtdChina · 1 NDC
- HAS Healthcare Advanced Synthesis SASwitzerland · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Olon USA LLCItaly · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
Orange Book patents
2 unexpired patents list isotretinoin as the active ingredient, expiring between May 2035 and Aug 2035. Application holder: SUN PHARMACEUTICAL INDUSTRIES LTD.
Enquiry
Common questions
- Who makes isotretinoin?
- 14 companies list isotretinoin as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc., Aurobindo Pharma Limited, Mayne Pharma International Pty Ltd.. 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 Absorica?
- 13 companies list isotretinoin under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies isotretinoin active ingredient?
- 5 companies list isotretinoin as a bulk ingredient, including Chongqing Huapont Pharmaceutical Co Ltd, HAS Healthcare Advanced Synthesis SA, Hetero Drugs Limited, Olon USA LLC.