Medicine
Winlevi 1% cream
Winlevi 1% cream is a prescription medicine containing Clascoterone for topical use, marketed by Sun Pharmaceutical Industries, 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
Store the product in a refrigerator between 36°F and 46°F (2°C and 8°C). Do…
Key facts
- Active ingredient (INN)
- Clascoterone
- Brand
- Winlevi
- Strength
- 1%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube
- Marketing authorisation holder
- Sun Pharmaceutical Industries
- Manufacturer
- Sun Pharmaceutical IndustriesIndia
- Origin register
- US FDA, United States
- Storage
- Store the product in a refrigerator between 36°F and 46°F (2°C and 8°C). Do not freeze. Do not freeze. Dispensing Instructions for the Pharmacist: Direct the patient to store the product while in use at room temperature, between 68°F and 77°F (20°C to 25°C).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D10AX06 Clascoterone
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 October 2021
- Identifiers
- RxCUI 2474344, 2474349DailyMed set ID 1673a84b-7f5c-47ab-a99c-1e3db21a6a09NDC 47335-994Application NDA213433
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 tube in 1 carton / 60 g in 1 tube | 47335-994-36 | Sun Pharmaceutical IndustriesIndia | 4 October 2021 |
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
Clinical summary
Clascoterone is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. It is available as cream for topical use. MedsAcross supplies Clascoterone 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 ClascoteroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Winlevi prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
- Winlevi: European public assessment report (EPAR) · European Medicines Agency
Need Winlevi 1% cream 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.