Medicine
Keytruda 100 mg/4 mL injection
Keytruda 100 mg/4 mL injection is a prescription medicine containing Pembrolizumab for intravenous use, marketed by Merck Sharp & Dohme, 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 vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original…
Key facts
- Active ingredient (INN)
- Pembrolizumab
- Brand
- Keytruda
- Strength
- 100 mg/4 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 4 mL, 2 vials of 4 mL
- Marketing authorisation holder
- Merck Sharp & Dohme
- Manufacturer
- Merck Sharp & Dohme
- Origin register
- US FDA, United States
- Storage
- Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01FF02 Pembrolizumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 January 2015
- Identifiers
- RxCUI 1657746, 1657749, 1657750 +1DailyMed set ID 9333c79b-d487-4538-a9f0-71b91a02b287NDC 0006-3026Application BLA125514
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 in 1 carton / 4 mL in 1 vial | 0006-3026-02 | Merck Sharp & Dohme | 15 January 2015 |
| 2 vial in 1 carton / 4 mL in 1 vial | 0006-3026-04 | Merck Sharp & Dohme | 1 August 2019 |
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
Pembrolizumab is a programmed death receptor-1 blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Pembrolizumab 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 PembrolizumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- KEYTRUDA prescribing information (Merck Sharp & Dohme) · U.S. National Library of Medicine, DailyMed
- Keytruda: European public assessment report (EPAR) · European Medicines Agency
Need Keytruda 100 mg/4 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.