Medicine
Omcazio 34.5 mg capsule
Omcazio 34.5 mg capsule is a prescription medicine containing Cabozantinib laurylsulfate for oral use, marketed by Handa Pharma, 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 OMCAZIO at 20°C to 25°C (68°F to 77°F), excursions are permitted from…
Key facts
- Active ingredient (INN)
- Cabozantinib laurylsulfate
- Brand
- Omcazio
- Strength
- 34.5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Handa Pharma
- Manufacturer
- Handa Pharma
- Origin register
- US FDA, United States
- Storage
- Store OMCAZIO at 20°C to 25°C (68°F to 77°F), excursions are permitted from 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2026
- Identifiers
- DailyMed set ID c0a58965-24c8-4f4e-ac71-9b36226c7b18NDC 17201-013Application NDA220613
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 bottle in 1 carton / 30 capsule in 1 bottle | 17201-013-30 | Handa Pharma | 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 3 September 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Other strengths and forms of Cabozantinib laurylsulfate
Clinical summary
Cabozantinib laurylsulfate is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC), among other approved uses. It is available as capsules for oral use. MedsAcross supplies Cabozantinib laurylsulfate 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 Cabozantinib laurylsulfateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Omcazio prescribing information (Handa Pharma) · U.S. National Library of Medicine, DailyMed
Need Omcazio 34.5 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.