Product/Composition:- | Gemfibrozil tablet/ Capsule |
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Strength:- | 600 mg |
Form:- | Tablet/Capsules |
Reference Brands:- | Lopid(US & EU) |
MOQ | As per the manufacturer batch size |
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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 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.