Medicine
Libtayo 350 mg/7 mL injection
Libtayo 350 mg/7 mL injection is a prescription medicine containing Cemiplimab for intravenous use, marketed by Regeneron Pharmaceuticals, 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 in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton…
Key facts
- Active ingredient (INN)
- Cemiplimab
- Brand
- Libtayo
- Strength
- 350 mg/7 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 7 mL
- Marketing authorisation holder
- Regeneron Pharmaceuticals
- Manufacturer
- Regeneron Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze or shake. Protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XC33 Cemiplimab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 September 2018
- Identifiers
- RxCUI 2058830, 2058835DailyMed set ID 4347ae1f-d397-4f18-8b70-03897e1c054aNDC 61755-008Application BLA761097
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 vial, single-use in 1 carton / 7 mL in 1 vial, single-use | 61755-008-01 | Regeneron Pharmaceuticals | 28 September 2018 |
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
Cemiplimab is a prescription medicine indicated for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. MedsAcross supplies Cemiplimab 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 CemiplimabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LIBTAYO prescribing information (Regeneron Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Libtayo: European public assessment report (EPAR) · European Medicines Agency
Need Libtayo 350 mg/7 mL injection 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.