Medicine
Tiopronin 300 mg delayed-release tablet
Tiopronin 300 mg delayed-release tablet is a generic prescription medicine for oral use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Key facts
- Active ingredient (INN)
- Tiopronin
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 90 tablets and 2 more
- Manufacturers
- Torrent PharmaceuticalsIndiaAmneal Pharmaceuticals NYBioComp PharmaPar HealthTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04BX16 Tiopronin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 January 2024
- Identifiers
- RxCUI 2178075, 2178079DailyMed set ID 1f2eb1d6-faa6-e352-e063-6294a90a7fb5, ad750031-08ec-4d92-af2d-97a80c454e14, 5396b9fd-5385-44fd-a8ba-e56a46a33bc7 +2NDC 44523-055, 13668-692, 0254-3035 +2Application NDA211843, ANDA216990, ANDA217219 +2
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 90 tablet, delayed release in 1 bottle | 13668-692-90 | Torrent PharmaceuticalsIndia | 30 January 2024 |
| 90 tablet, delayed release in 1 bottle | 60219-2009-9 | Amneal Pharmaceuticals NY | 2 January 2025 |
| 90 tablet, delayed release in 1 bottle | 44523-055-01 | BioComp Pharma | 5 December 2024 |
| 90 tablet, delayed release in 1 bottle | 0254-3035-09 | Par Health | 26 June 2024 |
| 90 tablet, delayed release in 1 bottle | 0480-7824-98 | Teva Pharmaceuticals | 8 October 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 11 August 1988 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Tiopronin 300 mg delayed-release tablet.
Other strengths and forms of Tiopronin
Clinical summary
Tiopronin is a reducing and complexing thiol indicated , in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults, among other approved uses. MedsAcross supplies Tiopronin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about TioproninFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Thiola prescribing information (Mission Pharmacal) · U.S. National Library of Medicine, DailyMed
Need Tiopronin 300 mg delayed-release tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.