Medicine
Tepmetko 225 mg tablet
Tepmetko 225 mg tablet is a prescription medicine containing Tepotinib for oral use, marketed by EMD Serono, 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 TEPMETKO at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C…
Key facts
- Active ingredient (INN)
- Tepotinib
- Brand
- Tepmetko
- Strength
- 225 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 3 blister pack, 6 blister pack
- Marketing authorisation holder
- EMD Serono
- Manufacturer
- EMD Serono
- Origin register
- US FDA, United States
- Storage
- Store TEPMETKO at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F). Store in original package.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EX21 Tepotinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 February 2021
- Identifiers
- RxCUI 2477266, 2477272DailyMed set ID 80a0f1b9-071a-47f5-9e67-32d638a669dcNDC 44087-5000Application NDA214096
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 |
|---|---|---|---|
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 44087-5000-3 | EMD Serono | 3 February 2021 |
| 6 blister pack in 1 carton / 10 tablet in 1 blister pack | 44087-5000-6 | EMD Serono | 3 February 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
Tepotinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. It is available as tablets for oral use. MedsAcross supplies Tepotinib 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 TepotinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TEPMETKO prescribing information (EMD Serono) · U.S. National Library of Medicine, DailyMed
- Tepmetko: European public assessment report (EPAR) · European Medicines Agency
Need Tepmetko 225 mg tablet 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.