Medicine
Thiotepa 15 mg powder for injection
Thiotepa 15 mg powder for injection is a generic prescription medicine for intracavitary, intravenous, intravesical 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. 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
Thiotepa for injection, USP vials must be stored and transported refrigerated…
Key facts
- Active ingredient (INN)
- Thiotepa
- Brand
- Sold under the generic name
- Strength
- 15 mg
- Dosage form
- Powder for injection
- Route
- Intracavitary, intravenous, intravesical
- Packs
- 1 vial and 2 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaGland PharmaIndiaNovadoz PharmaceuticalsIndiaMeitheal PharmaceuticalsSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Thiotepa for injection, USP vials must be stored and transported refrigerated at 2°C to 8°C (36° 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
- 4 May 2018
- Identifiers
- RxCUI 1660004, 1660009DailyMed set ID b702dcc9-dd0e-4386-b1e2-f20562fd2ad9, 6cd6ae89-c553-4328-9262-4363610a1f19, b3b21d90-96e3-48c0-a816-00c6636f3ce6 +2NDC 72205-045, 68083-446, 25021-267 +2Application ANDA213049, ANDA214222, ANDA216037 +1
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 |
|---|---|---|---|
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 43598-650-11 | Dr. Reddy's LaboratoriesIndia | 4 May 2018 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 68083-446-01 | Gland PharmaIndia | 8 March 2021 |
| 1 vial, glass in 1 box / 1 injection, powder, lyophilized, for solution in 1 vial, glass | 72205-045-01 | Novadoz PharmaceuticalsIndia | 1 February 2020 |
| 1 vial, single-dose in 1 carton / 1 injection, powder, for solution in 1 vial, single-dose | 71288-156-05 | Meitheal Pharmaceuticals | 26 December 2023 |
| 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 25021-267-05 | Sagent Pharmaceuticals | 1 November 2026 |
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 Thiotepa 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.