Medicine
Keytruda Qlex 2000 units/165 mg per mL injection
Keytruda Qlex 2000 units/165 mg per mL injection is a prescription medicine containing Berahyaluronidase alfa and Pembrolizumab for subcutaneous 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 refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to…
Key facts
- Active ingredient (INN)
- Berahyaluronidase alfa and Pembrolizumab
- Brand
- Keytruda Qlex
- Strength
- 2000 units/165 mg per mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial
- Marketing authorisation holder
- Merck Sharp & Dohme
- Manufacturer
- Merck Sharp & Dohme
- Origin register
- US FDA, United States
- Storage
- Store vials refrigerated 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
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 September 2025
- Identifiers
- RxCUI 2723762, 2723769, 2723771 +1DailyMed set ID 097d166f-b73b-41d3-9b37-7653cd2a0c41NDC 0006-3083, 0006-5083Application BLA761467
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 / 2.4 mL in 1 vial | 0006-3083-01 | Merck Sharp & Dohme | 19 September 2025 |
| 1 vial in 1 carton / 4.8 mL in 1 vial | 0006-5083-01 | Merck Sharp & Dohme | 19 September 2025 |
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 19 September 2025 | 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
Clinical summary
Berahyaluronidase alfa and Pembrolizumab is a fixed-dose combination of an endoglycosidase and a programmed death receptor-1 blocking antibody indicated for the treatment of adult patients with unresectable or metastatic melanoma, among other approved uses. MedsAcross supplies Berahyaluronidase alfa and 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 Berahyaluronidase alfa and 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 QLEX prescribing information (Merck Sharp & Dohme) · U.S. National Library of Medicine, DailyMed
Need Keytruda Qlex 2000 units/165 mg per 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.