Medicine
Sunitinib 25 mg capsule
Sunitinib 25 mg capsule is a generic prescription medicine for oral use, made by 8 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 at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Sunitinib
- Brand
- Sold under the generic name
- Strength
- 25 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 28 capsules, 4 blister pack and 8 more
- Manufacturers
- Aurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaNovadoz PharmaceuticalsIndiaAvKAREMylan PharmaceuticalsNovugen PharmaTeva Pharmaceuticals
- 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).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EX01 Sunitinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 December 2019
- Identifiers
- RxCUI 616279, 616285, 616289 +1DailyMed set ID 04d34bce-1296-d2b9-e063-6394a90a7018, 810dfcb2-d35b-4971-887c-2e78e82e9e07, a9479e5f-914f-46ca-95c1-327c66457e47 +5NDC 82293-015, 59651-465, 0093-8224 +5Application ANDA218012, ANDA218615, ANDA213803 +4
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 |
|---|---|---|---|
| 28 capsule in 1 bottle | 59651-465-28 | Aurobindo PharmaIndia | 14 March 2024 |
| 4 blister pack in 1 carton / 7 capsule in 1 blister pack | 59651-465-29 | Aurobindo PharmaIndia | 14 March 2024 |
| 4 blister pack in 1 carton / 7 capsule in 1 blister pack | 43598-046-28 | Dr. Reddy's LaboratoriesIndia | 30 November 2022 |
| 28 capsule in 1 bottle | 43598-046-63 | Dr. Reddy's LaboratoriesIndia | 30 November 2022 |
| 28 capsule in 1 bottle | 72205-117-28 | Novadoz PharmaceuticalsIndia | 1 June 2025 |
| 28 capsule in 1 bottle | 63304-092-27 | Sun Pharmaceutical IndustriesIndia | 25 December 2019 |
| 4 blister pack in 1 box / 7 capsule in 1 blister pack | 63304-092-86 | Sun Pharmaceutical IndustriesIndia | 25 December 2019 |
| 28 capsule in 1 bottle, plastic | 0378-6679-28 | Mylan Pharmaceuticals | 4 January 2022 |
| 28 capsule in 1 bottle | 82293-015-10 | Novugen Pharma | 1 May 2024 |
| 28 capsule in 1 bottle | 0093-8224-28 | Teva Pharmaceuticals | 22 December 2021 |
| 28 capsule in 1 bottle | 42291-902-28 | AvKARE | 11 October 2023 |
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 Sunitinib 25 mg capsule.
Other strengths and forms of Sunitinib
Clinical summary
Sunitinib is a kinase inhibitor indicated for treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Sunitinib 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 SunitinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SUTENT prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
- Sutent: European public assessment report (EPAR) · European Medicines Agency
- Sunitinib Accord: European public assessment report (EPAR) · European Medicines Agency
Need Sunitinib 25 mg capsule 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.