Imiglucerase Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 200 U/vial, 400 U/vial
Reference Brands: Cerezyme (USA/EU/ India), VPRIV (EU)
Category:
Immune Disorder
Imiglucerase is a recombinant DNA–derived form of the human enzyme β-glucocerebrosidase, used in enzyme replacement therapy for patients with Type 1 Gaucher disease. It helps break down fatty substances (glucocerebrosides) that accumulate in organs and tissues, thereby reducing symptoms such as anemia, enlarged liver/spleen, and bone pain.
Imiglucerase is available in Injection
and strengths such as 200 U/vial, 400 U/vial.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Imiglucerase is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Imiglucerase can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
Imiglucerase is a recombinant DNA-produced analogue of the human enzyme β-glucocerebrosidase, formulated for intravenous administration to treat Gaucher disease types 1 and 3. Gaucher disease is a rare lysosomal storage disorder caused by a deficiency of β-glucocerebrosidase, leading to the accumulation of glucocerebroside in macrophages. This accumulation results in enlarged liver and spleen, anemia, thrombocytopenia, and skeletal complications.
Cerezyme is a highly purified freeze-dried formulation of imiglucerase manufactured by Genzyme Corporation. The enzyme is reconstituted prior to intravenous infusion. Each vial contains either 200 or 400 units of imiglucerase, with recombinant enzyme activity of approximately 40 units/mg. The standard dosing regimen is 2.5 units/kg every two weeks, which may be adjusted up to 60 units/kg depending on clinical response. Imiglucerase has been shown to effectively reduce glucocerebroside accumulation, improve organ function, and alleviate clinical symptoms associated with Gaucher disease.
This therapy is well-tolerated and is approved for patients aged 2 years and above. Due to its targeted mechanism of action and clinical efficacy, imiglucerase has been granted orphan drug status in multiple regions, including the United States, Australia, and Japan. It represents a cornerstone in enzyme replacement therapy for managing Gaucher disease.
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