Medicine
Topotecan 4 mg/4 mL powder for injection
Topotecan 4 mg/4 mL powder for injection is a generic prescription medicine for intravenous use, made by 3 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 between 20°C and 25°C (68°F and 77°F) in original carton. Protect from…
Key facts
- Active ingredient (INN)
- Topotecan
- Brand
- Sold under the generic name
- Strength
- 4 mg/4 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Manufacturers
- Accord HealthcareIndiaActavis PharmaFresenius Kabi
- Origin register
- US FDA, United States
- Storage
- Store between 20°C and 25°C (68°F and 77°F) in original carton. Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01CE01 Topotecan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 November 2010
- Identifiers
- RxCUI 1799416DailyMed set ID 729b2b22-1344-44f3-b614-14f6ec3c263e, b6019088-cd94-43b4-b5ce-ba20b6b8021e, 996430c0-ee26-4ed9-82b8-a8b645becba6NDC 16729-151, 63323-762, 45963-615Application ANDA202351, ANDA091089, ANDA090620
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 package / 4 mL in 1 vial | 16729-151-31 | Accord HealthcareIndia | 23 July 2013 |
| 1 vial in 1 carton / 4 mL in 1 vial | 45963-615-56 | Actavis Pharma | 5 January 2015 |
| 1 vial in 1 box / 4 mL in 1 vial | 63323-762-10 | Fresenius Kabi | 30 November 2010 |
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 Topotecan 4 mg/4 mL powder for injection.
Other strengths and forms of Topotecan
Clinical summary
Topotecan is a topoisomerase inhibitor indicated for treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent, among other approved uses. MedsAcross supplies Topotecan 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 TopotecanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- HYCAMTIN prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Hycamtin: European public assessment report (EPAR) · European Medicines Agency
- Topotecan Hospira: European public assessment report (EPAR) · European Medicines Agency
Need Topotecan 4 mg/4 mL 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.