Medicine
Cuvrior 300 mg tablet
Cuvrior 300 mg tablet is a prescription medicine containing Trientine tetrahydrochloride for oral use, marketed by Orphalan, 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 a controlled room temperature of 20°C to 25°C (68°F to 77°F)…
Key facts
- Active ingredient (INN)
- Trientine tetrahydrochloride
- Brand
- Cuvrior
- Strength
- 300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 9 cartons
- Marketing authorisation holder
- Orphalan
- Manufacturer
- Orphalan
- Origin register
- US FDA, United States
- Storage
- Store at a controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions between 15°C and 30°C (59°F and 86°F) are permitted.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 September 2022
- Identifiers
- RxCUI 2611544, 2611550DailyMed set ID f73feeae-62ad-401e-b9f7-5cb269127750NDC 81802-001Application NDA215760
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 9 carton in 1 carton / 1 blister pack in 1 carton / 8 tablet, film coated in 1 blister pack | 81802-001-72 | Orphalan | 14 September 2022 |
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 28 April 2022 | 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
Clinical summary
Trientine tetrahydrochloride is a copper chelator indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine. It is available as tablets for oral use. MedsAcross supplies Trientine tetrahydrochloride 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 Trientine tetrahydrochlorideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CUVRIOR prescribing information (Orphalan) · U.S. National Library of Medicine, DailyMed
Need Cuvrior 300 mg 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.