Alirocumab Subcutaneous Injection Suppliers & Bulk Manufacturers
Available Forms: Subcutaneous Injection
Available Strengths: 75 mg/mL and 150 mg/mL
Reference Brands: Praluent(US & EU)
Category: Heart Disorder
Alirocumab Subcutaneous Injection is available in Subcutaneous Injection and strengths such as 75 mg/mL and 150 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, Alirocumab 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) |
Alirocumab 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: Alirocumab, marketed as Praluent, 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 risk. Regulatory approval requires a comprehensive dossier including clinical trial data, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical and quality data to ensure safety and efficacy, while the EMA evaluates regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regulatory adherence supports timely approval, safe use, and global availability of alirocumab subcutaneous injections, contributing to improved cardiovascular health worldwide.
Frequently Asked Questions
Related Products
Aliskiren Tablets
Strength: 150 mg, 300 mg
Form: Tablets
Reference Brands: Tekturna(US & EU)
View Details
Atenolol Tablets
Strength: 25 mg, 50 mg, 100 mg
Form: Tablets
Reference Brands: Tenormin(US)
View Details
Metoprolol Tartrate Tablet
Strength: IR: 25 mg, 50 mg, 100 mg; ER: 25 mg, 50 mg, 100 mg, 200 mg
Form: Tablets(IR & ER)
Reference Brands: US: Lopressor(IR); Toprol-XL(ER)
View Details
Nifedipine Tablets(Ir/Er)
Strength: 10 mg, 20 mg, 30 mg, 60 mg, 90 mg (IR and ER forms)
Form: Tablet(IR & ER)
Reference Brands: Procardia(US);
View DetailsQuick Response Guaranteed | Verified Suppliers