Medicine
Elevidys kit
Elevidys kit is a prescription medicine containing Delandistrogene moxeparvovec for intravenous use, marketed by Sarepta Therapeutics, 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
ELEVIDYS can be refrigerated for up to 14 days when stored at 2°C to 8°C (36º…
Key facts
- Active ingredient (INN)
- Delandistrogene moxeparvovec
- Brand
- Elevidys
- Dosage form
- Kit
- Route
- Intravenous
- Packs
- 1 kit and 58 more
- Marketing authorisation holder
- Sarepta Therapeutics
- Manufacturer
- Sarepta Therapeutics
- Origin register
- US FDA, United States
- Storage
- ELEVIDYS can be refrigerated for up to 14 days when stored at 2°C to 8°C (36º F to 46º F) in the upright position. Do not place back in the refrigerator once brought to room temperature. ELEVIDYS is shipped and delivered at ≤ −60ºC [−76ºF]. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M09AX15 Delandistrogene moxeparvovec
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 June 2023
- Identifiers
- RxCUI 797544, 2641679, 2641685 +7DailyMed set ID 3525abcd-fbd2-46c5-9706-cffdf2e8a361NDC 60923-520, 60923-548, 60923-558 +37Application BLA125781
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 * 10 mL in 1 vial, single-use * 10 pouch in 1 box / 1 swab in 1 pouch | 60923-501-10 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 11 pouch in 1 box / 1 swab in 1 pouch | 60923-502-11 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 12 pouch in 1 box / 1 swab in 1 pouch | 60923-503-12 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 13 pouch in 1 box / 1 swab in 1 pouch * 10 mL in 1 vial, single-use | 60923-504-13 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 14 pouch in 1 box / 1 swab in 1 pouch | 60923-505-14 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 15 pouch in 1 box / 1 swab in 1 pouch | 60923-506-15 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 16 pouch in 1 box / 1 swab in 1 pouch | 60923-507-16 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 17 pouch in 1 box / 1 swab in 1 pouch | 60923-508-17 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 18 pouch in 1 box / 1 swab in 1 pouch | 60923-509-18 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 19 pouch in 1 box / 1 swab in 1 pouch | 60923-510-19 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 20 pouch in 1 box / 1 swab in 1 pouch | 60923-511-20 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 21 pouch in 1 box / 1 swab in 1 pouch | 60923-512-21 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 22 pouch in 1 box / 1 swab in 1 pouch | 60923-513-22 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 23 pouch in 1 box / 1 swab in 1 pouch | 60923-514-23 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 24 pouch in 1 box / 1 swab in 1 pouch | 60923-515-24 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 25 pouch in 1 box / 1 swab in 1 pouch | 60923-516-25 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 26 pouch in 1 box / 1 swab in 1 pouch | 60923-517-26 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 27 pouch in 1 box / 1 swab in 1 pouch | 60923-518-27 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 28 pouch in 1 box / 1 swab in 1 pouch | 60923-519-28 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 29 pouch in 1 box / 1 swab in 1 pouch | 60923-520-29 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 30 pouch in 1 box / 1 swab in 1 pouch | 60923-521-30 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 31 pouch in 1 box / 1 swab in 1 pouch | 60923-522-31 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 32 pouch in 1 box / 1 swab in 1 pouch | 60923-523-32 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 33 pouch in 1 box / 1 swab in 1 pouch | 60923-524-33 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 34 pouch in 1 box / 1 swab in 1 pouch | 60923-525-34 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 35 pouch in 1 box / 1 swab in 1 pouch | 60923-526-35 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 36 pouch in 1 box / 1 swab in 1 pouch | 60923-527-36 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 37 pouch in 1 box / 1 swab in 1 pouch | 60923-528-37 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 38 pouch in 1 box / 1 swab in 1 pouch | 60923-529-38 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 39 pouch in 1 box / 1 swab in 1 pouch | 60923-530-39 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 40 pouch in 1 box / 1 swab in 1 pouch | 60923-531-40 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 41 pouch in 1 box / 1 swab in 1 pouch | 60923-532-41 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 42 pouch in 1 box / 1 swab in 1 pouch | 60923-533-42 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 43 pouch in 1 box / 1 swab in 1 pouch | 60923-534-43 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 44 pouch in 1 box / 1 swab in 1 pouch | 60923-535-44 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 45 pouch in 1 box / 1 swab in 1 pouch | 60923-536-45 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 46 pouch in 1 box / 1 swab in 1 pouch | 60923-537-46 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 47 pouch in 1 box / 1 swab in 1 pouch | 60923-538-47 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 48 pouch in 1 box / 1 swab in 1 pouch | 60923-539-48 | Sarepta Therapeutics | 22 June 2023 |
| 1 kit in 1 carton * 10 mL in 1 vial, single-use * 49 pouch in 1 box / 1 swab in 1 pouch | 60923-540-49 | Sarepta Therapeutics | 22 June 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
Delandistrogene moxeparvovec is a prescription medicine indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene. MedsAcross supplies Delandistrogene moxeparvovec 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 Delandistrogene moxeparvovecFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ELEVIDYS prescribing information (Sarepta Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Elevidys 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.