Eliglustat Capsule Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 84 mg
Reference Brands: Cerdelga®(US & EU)
Category:
Orphan Drugs
Eliglustat capsules, used for Gaucher disease type 1, work by inhibiting the enzyme glucosylceramide synthase, reducing harmful enzyme activity. Benefits include effective oral administration, improved disease management, and fewer side effects compared to enzyme replacement therapy, leading to better quality of life for patients with Gaucher disease.
Eliglustat capsule is available in Capsules
and strengths such as 84 mg.
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, Eliglustat capsule 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) |
Eliglustat capsule 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:
Eliglustat capsules, marketed as Cerdelga®, are approved for treating Gaucher disease type 1 in both the US and EU. The FDA and EMA reviewed comprehensive regulatory dossiers, including clinical trial data, manufacturing standards, and safety profiles, to ensure high-quality standards. These dossiers support regulatory approval and facilitate market access. Cerdelga® capsules are available in an 84 mg strength, offering an effective oral therapy option. For detailed information on the regulatory process, dossier submissions, and market approvals, visit PharmaTradz, your source for pharmaceutical regulatory insights and updates.
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