Medicine
Vyondys 53 100 mg/2 mL injection
Vyondys 53 100 mg/2 mL injection is a prescription medicine containing Golodirsen 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
Store VYONDYS 53 at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in…
Key facts
- Active ingredient (INN)
- Golodirsen
- Brand
- Vyondys 53
- Strength
- 100 mg/2 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 2 mL
- Marketing authorisation holder
- Sarepta Therapeutics
- Manufacturer
- Sarepta Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store VYONDYS 53 at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in original carton until ready for use to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 December 2019
- Identifiers
- RxCUI 2267211, 2267216DailyMed set ID 35c227d1-5b24-44b0-b5d3-f0f6b1c46bd5NDC 60923-465Application NDA211970
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 / 2 mL in 1 vial, single-use | 60923-465-02 | Sarepta Therapeutics | 12 December 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 12 December 2019 | 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
Golodirsen is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. MedsAcross supplies Golodirsen 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 GolodirsenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Vyondys 53 prescribing information (Sarepta Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Vyondys 53 100 mg/2 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.