Vyjuvek kit is a generic prescription medicine, 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
If a freezer is not available, the carton can be refrigerated in the pharmacy…
Key facts
- Active ingredient (INN)
- Vyjuvek
- Brand
- Sold under the generic name
- Dosage form
- Kit
- Packs
- 1 kit
- Manufacturer
- Krystal Biotech
- Origin register
- US FDA, United States
- Storage
- If a freezer is not available, the carton can be refrigerated in the pharmacy (2° to 8°C (35.6° to 46.4°F)) for up to 1 month. Store the VYJUVEK carton in the pharmacy at -15°C to -25°C (5°F to -13°F). Administration syringes containing the VYJUVEK gel may remain at room temperature (20 to 25°C (68° to 77°F)) for up to 8 hours prior to application.
- 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 May 2023
- Identifiers
- RxCUI 2637762, 2637767DailyMed set ID fe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c2NDC 82194-510Application BLA125774
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 kit in 1 carton * 1 mL in 1 vial * 1.5 mL in 1 vial | 82194-510-02 | Krystal Biotech | 19 May 2023 |
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 |
| 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
Vyjuvek is a prescription medicine indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. MedsAcross supplies Vyjuvek 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 VyjuvekFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VYJUVEK prescribing information (Krystal Biotech) · U.S. National Library of Medicine, DailyMed
Need Vyjuvek kit 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.