Rosuvastatin Calcium Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 5 mg, 10 mg, 20 mg, 40 mg
Reference Brands: Crestor(US & EU)
Category:
Heart Disorder
Rosuvastatin inhibits HMG-CoA reductase, reducing cholesterol synthesis in the liver. It effectively lowers LDL cholesterol, raises HDL, and reduces atherosclerosis risk. Benefits include preventing heart attacks, strokes, and cardiovascular events, supporting overall heart health and long-term management of hyperlipidemia for improved survival outcomes.
Rosuvastatin Calcium tablets is available in Tablets
and strengths such as 5 mg, 10 mg, 20 mg, 40 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, Rosuvastatin Calcium tablets 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) |
Rosuvastatin Calcium tablets 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:
Rosuvastatin tablets, marketed as Crestor, are approved in the US by the FDA and in the EU via EMA for managing hyperlipidemia and reducing cardiovascular risk. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports prompt approval, safe use, and global availability of rosuvastatin tablets, helping reduce the risk of heart disease and support cardiovascular health worldwide.
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