Drug
Who makes cysteamine bitartrate?
2 companies list cysteamine bitartrate as a human prescription drug, including under the names Cystagon, PROCYSBI. Forms: capsule; capsule, delayed release pellets; granule, delayed release. 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 cysteamine bitartrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Horizon Pharmaceuticals , Inc.United States | capsule, delayed release pellets; granule, delayed release | NDANDA203389, NDA213491 | 4 | 1 |
| Mylan Pharmaceuticals, Inc. | capsule | NDANDA020392 | 2 | 0 |
Bulk ingredient listings
- AZICO BIOPHORE INDIA PRIVATE LIMITEDIndia · 1 NDC
- Anonima Materie Sintetiche and Affini (AMSA) SpA · 1 NDC
- CAMBREX PROFARMACO MILANO SRLItaly · 1 NDC
- Farmabios S.p.A.Italy · 1 NDC
- Maithri Laboratories Private LimitedIndia · 1 NDC
Orange Book patents
24 unexpired patents list cysteamine bitartrate as the active ingredient, expiring between Jan 2027 and Feb 2037. Application holder: HORIZON THERAPEUTICS USA INC.
Enquiry
Common questions
- Who makes cysteamine bitartrate?
- 2 companies list cysteamine bitartrate as a human prescription drug in the openFDA NDC Directory, led by Horizon Pharmaceuticals , Inc., Mylan Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Who supplies cysteamine bitartrate active ingredient?
- 5 companies list cysteamine bitartrate as a bulk ingredient, including AZICO BIOPHORE INDIA PRIVATE LIMITED, Anonima Materie Sintetiche and Affini (AMSA) SpA, CAMBREX PROFARMACO MILANO SRL, Farmabios S.p.A..