Medicine
Tepadina 15 mg powder for injection
Tepadina 15 mg powder for injection is a prescription medicine containing Thiotepa for intracavitary, intravenous, intravesical use, marketed by Amneal Pharmaceuticals, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
TEPADINA multichamber flexible bag and vials must be stored and transported…
Key facts
- Active ingredient (INN)
- Thiotepa
- Brand
- Tepadina
- Strength
- 15 mg
- Dosage form
- Powder for injection
- Route
- Intracavitary, intravenous, intravesical
- Packs
- 1 vial
- Marketing authorisation holder
- Amneal Pharmaceuticals
- Manufacturer
- Amneal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- TEPADINA multichamber flexible bag and vials must be stored and transported refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01AC01 Thiotepa
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 August 2017
- Identifiers
- RxCUI 1660004, 1660009, 1919209 +5DailyMed set ID 559e353c-2dc0-16ba-e054-00144ff8d46cNDC 70121-1630Application NDA208264
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 |
|---|---|---|---|
| 1 vial, glass in 1 box / 1 injection, powder, for solution in 1 vial, glass | 70121-1630-1 | Amneal Pharmaceuticals | 15 August 2017 |
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.
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 Thiotepa 15 mg powder for injection.
Other strengths and forms of Thiotepa
Clinical summary
Thiotepa is an alkylating drug. It is available as powder for injection for intracavitary, intravenous and intravesical use. MedsAcross supplies Thiotepa 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 ThiotepaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TEPADINA prescribing information (Amneal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Tepadina: European public assessment report (EPAR) · European Medicines Agency
- Thiotepa Riemser: European public assessment report (EPAR) · European Medicines Agency
Need Tepadina 15 mg powder for 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.