Medicine
Lumizyme 5 mg/mL powder for injection
Lumizyme 5 mg/mL powder for injection is a prescription medicine containing Alglucosidase 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 LUMIZYME under refrigeration between 2°C and 8°C (36°F and 46°F).
Key facts
- Active ingredient (INN)
- Alglucosidase alfa
- Brand
- Lumizyme
- 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
- Store LUMIZYME under refrigeration between 2°C and 8°C (36°F and 46°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AB07 Alglucosidase alfa
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 May 2010
- Identifiers
- RxCUI 629568, 993072DailyMed set ID d6bfbc45-2d34-439e-8aad-59ee2d53d4dfNDC 58468-0160Application BLA125291
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 / 10.5 mL in 1 vial, single-use | 58468-0160-1 | Genzyme | 24 May 2010 |
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
Alglucosidase alfa is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [GAA] deficiency). It is available as powder for injection for intravenous use. MedsAcross supplies Alglucosidase 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 Alglucosidase 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
- Lumizyme prescribing information (Genzyme) · U.S. National Library of Medicine, DailyMed
- Myozyme: European public assessment report (EPAR) · European Medicines Agency
Need Lumizyme 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.