Drug
Who makes tiopronin?
7 companies list tiopronin as a human prescription drug, including under the names Thiola, Thiola EC, VENXXIVA. Forms: tablet, delayed release; tablet, sugar coated. 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 tiopronin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Mission Pharmacal CompanyUnited States | tablet, delayed release; tablet, sugar coated | NDANDA019569, NDA211843 | 3 | 1 |
| BioComp Pharma, Inc. | tablet, delayed release; tablet, sugar coated | NDA AUTHORIZED GENERICNDA019569, NDA211843 | 3 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, delayed release | ANDAANDA216456 | 2 | 6 |
| Par Health USA, LLCIndia | tablet, delayed release | ANDAANDA217219 | 2 | 5 |
| Torrent Pharma, Inc.India | tablet, delayed release | ANDAANDA216990 | 2 | 5 |
| Cycle Pharmaceuticals Ltd-Uk | tablet, delayed release | ANDAANDA216990 | 2 | 0 |
| Amneal Pharmaceuticals NY LLC | tablet, delayed release | ANDAANDA216278 | 1 | 0 |
Bulk ingredient listings
- AZICO BIOPHORE INDIA PRIVATE LIMITEDIndia · 1 NDC
- Dasami Lab Private LimitedIndia · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- Porton Pharma Solutions LtdChina · 1 NDC
- SCL Lifesciences LimitedIndia · 1 NDC
Orange Book patents
1 unexpired patent lists tiopronin as the active ingredient, expiring between Nov 2038 and Nov 2038. Application holder: MISSION PHARMACAL CO.
Enquiry
Common questions
- Who makes tiopronin?
- 7 companies list tiopronin as a human prescription drug in the openFDA NDC Directory, led by Mission Pharmacal Company, BioComp Pharma, Inc., Teva Pharmaceutical Industries Ltd., Par Health USA, LLC, Torrent Pharma, Inc.. 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 Thiola?
- 5 companies list tiopronin 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 tiopronin active ingredient?
- 6 companies list tiopronin as a bulk ingredient, including AZICO BIOPHORE INDIA PRIVATE LIMITED, Dasami Lab Private Limited, MSN Life Sciences Private Limited, NURAY CHEMICALS PRIVATE LIMITED.