Medicine
Elfabrio 20 mg/10 mL injection
Elfabrio 20 mg/10 mL injection is a prescription medicine containing Pegunigalsidase alfa for intravenous use, marketed by Chiesi, 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 refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake.
Key facts
- Active ingredient (INN)
- Pegunigalsidase alfa
- Brand
- Elfabrio
- Strength
- 20 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 10 mL, 5 vials of 10 mL, 10 vials of 10 mL
- Marketing authorisation holder
- Chiesi
- Manufacturer
- Chiesi
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AB20 Pegunigalsidase alfa
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 May 2023
- Identifiers
- RxCUI 2637456, 2637462, 2676759 +1DailyMed set ID 6fb674bf-744e-431f-92ef-b2a5a66c8cf3NDC 10122-160Application BLA761161
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-dose in 1 carton / 10 mL in 1 vial, single-dose | 10122-160-02 | Chiesi | 23 May 2023 |
| 5 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 10122-160-05 | Chiesi | 23 May 2023 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 10122-160-10 | Chiesi | 23 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.
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
Other strengths and forms of Pegunigalsidase alfa
Clinical summary
Pegunigalsidase alfa is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease. It is available as injection for intravenous use. MedsAcross supplies Pegunigalsidase alfa 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 Pegunigalsidase alfaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ELFABRIO prescribing information (Chiesi) · U.S. National Library of Medicine, DailyMed
- Elfabrio: European public assessment report (EPAR) · European Medicines Agency
Need Elfabrio 20 mg/10 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.