Medicine
Fabrazyme 5 mg/mL powder for injection
Fabrazyme 5 mg/mL powder for injection is a prescription medicine containing Agalsidase beta for intravenous use, marketed by Genzyme, 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
Refrigerate vials of FABRAZYME at 2°C to 8°C (36°F to 46°F). If immediate use…
Key facts
- Active ingredient (INN)
- Agalsidase beta
- Brand
- Fabrazyme
- Strength
- 5 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Genzyme
- Manufacturer
- Genzyme
- Origin register
- US FDA, United States
- Storage
- Refrigerate vials of FABRAZYME at 2°C to 8°C (36°F to 46°F). If immediate use is not possible, the reconstituted and diluted solution may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AB04 Agalsidase alfa
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 December 2008
- Identifiers
- RxCUI 1804755, 1804758, 1804760 +1DailyMed set ID 988513ab-b06f-4dd0-93f7-d2d4531dcce4NDC 58468-0040, 58468-0041Application BLA103979
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
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
Clinical summary
Agalsidase beta is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. MedsAcross supplies Agalsidase beta 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 Agalsidase betaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fabrazyme prescribing information (Genzyme) · U.S. National Library of Medicine, DailyMed
- Fabrazyme: European public assessment report (EPAR) · European Medicines Agency
Need Fabrazyme 5 mg/mL powder for 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.