Evolocumab Subcutaneous Injection Suppliers & Bulk Manufacturers
Available Forms: Subcutaneous Injection
Available Strengths: 140 mg/mL
Reference Brands: Repatha(US & EU)
Category: Heart Disorder
Evolocumab is a monoclonal antibody that inhibits PCSK9, increasing LDL receptor availability to clear LDL cholesterol from the blood. It effectively lowers LDL cholesterol levels, reduces cardiovascular risk, and supports long-term lipid management. Benefits include significant LDL reductions, improved heart health, and prevention of atherosclerotic events. Evolocumab Subcutaneous Injection is available in Subcutaneous Injection and strengths such as 140 mg/mL. 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, Evolocumab Subcutaneous Injection 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) |
Evolocumab Subcutaneous Injection 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: Evolocumab, marketed as Repatha, is approved in the US by the FDA and in the EU via EMA for lowering LDL cholesterol in patients with familial hypercholesterolemia or cardiovascular disease. Regulatory approval requires a detailed dossier including clinical trial efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical and quality documents, while the EMA assesses regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional adherence supports timely approval, safe use, and global availability of evolocumab, helping improve cardiovascular health outcomes worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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