Gemfibrozil Tablet/ Capsule Suppliers & Bulk Manufacturers
Available Forms: Tablet/Capsules
Available Strengths: 600 mg
Reference Brands: Lopid(US & EU)
Category:
Heart Disorder
Gemfibrozil is a fibrate that activates PPARα receptors, improving lipid metabolism. It significantly lowers triglycerides, increases HDL cholesterol, and modestly reduces LDL cholesterol. Benefits include reducing cardiovascular risk, preventing pancreatitis, and supporting long-term management of dyslipidemia, promoting overall heart health and metabolic balance.
Gemfibrozil tablet/ Capsule is available in Tablet/Capsules
and strengths such as 600 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, Gemfibrozil tablet/ 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) |
Gemfibrozil tablet/ 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:
Gemfibrozil tablets and capsules, marketed as Lopid, are approved in the US by the FDA and in the EU via EMA for treating hypertriglyceridemia. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality data, while the EMA ensures regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and worldwide availability, helping patients manage dyslipidemia effectively and reduce cardiovascular risk across regions.
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