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Laronidase 2.9mg

Product Overview

Generic NameLaronidase 2.9mg
Brand Name(s)Aldurazyme®
CategoryImmuno Therapies
Formsingle use vial, Concentrate for solution for infusion
Strength2.9mg/5mL / 0.58 mg/mL
Therapeutic Classrecombinant human α-L-iduronidase
ATC CodeA16AB05

Manufacturing & Regulatory

ManufacturerBioMarin, Genzyme
GMP ComplianceWHO-GMP
COFEPRIS010.000.5547.00.00
Free Sale CertificateYes, available as COPP/CPP

Logistics & Export

MOQ5 units
Shelf Life36 months
Storage2–8 °C, protect from light
IncotermsEXW, HS 30049091
Lead Time7 - 10 Business Days

Documentation Available Upon Request

Certificate of Analysis (PDF)Supplied per batch upon request
CTD Summary (PDF)Not publicly available as parallel traded molecule

Special Notes

Laronidase is a recombinant α-L-iduronidase enzyme replacement therapy indicated for long-term treatment of patients with confirmed mucopolysaccharidosis I / MPS I to address the non-neurological manifestations of disease. It is used in Hurler and Hurler-Scheie forms and in Scheie patients with moderate to severe symptoms