Medicine
Tralement 0.3 mg/55 mcg/60 mcg/3 mg per 1 mL injection
Tralement 0.3 mg/55 mcg/60 mcg/3 mg per 1 mL injection is a prescription medicine containing Cupric sulfate, Manganese sulfate, Selenious acid and Zinc sulfate for intravenous use, marketed by American Regent, 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 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Cupric sulfate, Manganese sulfate, Selenious acid and Zinc sulfate
- Brand
- Tralement
- Strength
- 0.3 mg/55 mcg/60 mcg/3 mg per 1 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 25 vials of 1 mL
- Marketing authorisation holder
- American Regent
- Manufacturer
- American Regent
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store admixed solution at 2ºC to 8ºC (36ºF to 46ºF).
- 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
- 29 September 2020
- Identifiers
- RxCUI 2693627, 2693633DailyMed set ID a49ffb90-f307-433e-a86e-aaea6d6a9982NDC 0517-9305Application NDA209376
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 |
|---|---|---|---|
| 25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 0517-9305-25 | American Regent | 29 September 2020 |
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 2 July 2020 | 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
Other strengths and forms of Cupric sulfate, Manganese sulfate, Selenious acid and Zinc sulfate
Clinical summary
Cupric sulfate, Manganese sulfate, Selenious acid and Zinc sulfate is a fixed-dose combination of a copper absorption inhibitor and a paramagnetic contrast agent. MedsAcross supplies Cupric sulfate, Manganese sulfate, Selenious acid and Zinc sulfate 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 Cupric sulfate, Manganese sulfate, Selenious acid and Zinc sulfateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tralement prescribing information (American Regent) · U.S. National Library of Medicine, DailyMed
Need Tralement 0.3 mg/55 mcg/60 mcg/3 mg per 1 mL injection 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.