Medicine
Xenpozyme 4 mg/1.1 mL powder for injection
Xenpozyme 4 mg/1.1 mL powder for injection is a prescription medicine containing Olipudase alfa 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
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. For storage of…
Key facts
- Active ingredient (INN)
- Olipudase alfa
- Brand
- Xenpozyme
- Strength
- 4 mg/1.1 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Genzyme
- Manufacturer
- Genzyme
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. For storage of reconstituted and diluted solution.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AB25 Olipudase alfa
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 August 2022
- Identifiers
- RxCUI 2610411, 2610416, 2634357 +1DailyMed set ID 01a910ee-a33e-4be3-ac41-322d64c34311NDC 58468-0051Application BLA761261
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 in 1 carton / 1.1 mL in 1 vial | 58468-0051-1 | Genzyme | 29 August 2022 |
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 Olipudase alfa
Clinical summary
Olipudase alfa is a prescription medicine indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. It is available as powder for injection for intravenous use. MedsAcross supplies Olipudase 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 Olipudase 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
- XENPOZYME prescribing information (Genzyme) · U.S. National Library of Medicine, DailyMed
- Xenpozyme: European public assessment report (EPAR) · European Medicines Agency
Need Xenpozyme 4 mg/1.1 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.