Medicine
Odomzo 200 mg capsule
Odomzo 200 mg capsule is a prescription medicine containing Sonidegib for oral 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Key facts
- Active ingredient (INN)
- Sonidegib
- Brand
- Odomzo
- Strength
- 200 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules
- Marketing authorisation holder
- Sun Pharmaceutical Industries
- Manufacturer
- Sun Pharmaceutical IndustriesIndia
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (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
- L01XJ02 Sonidegib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 September 2017
- Identifiers
- RxCUI 1659921, 1659927DailyMed set ID 028312dc-d155-4fd5-8abd-6bb9f011d3ccNDC 47335-303Application NDA205266
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 |
|---|---|---|---|
| 30 capsule in 1 bottle | 47335-303-15 | Sun Pharmaceutical IndustriesIndia | 21 September 2017 |
| 30 capsule in 1 bottle | 47335-303-83 | Sun Pharmaceutical IndustriesIndia | 21 September 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
Clinical summary
Sonidegib is a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those, among other approved uses. MedsAcross supplies Sonidegib 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 SonidegibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Odomzo prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
- Odomzo: European public assessment report (EPAR) · European Medicines Agency
Need Odomzo 200 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.