Bempedoic Acid tablets bulk supplier for pharma manufacturers

Bempedoic Acid Tablets 180 mg Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: 180 mg

Reference Brands: Nexletol(US & EU)

Bempedoic acid 180 mg tablets, a once-daily ATP citrate lyase inhibitor used for raised LDL cholesterol. For importers, distributors and hospital buyers who need to check patent status and dossier availability by market.

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Product Description:

Bempedoic acid is a lipid-lowering medicine that acts one step before the statin target. It inhibits ATP citrate lyase in the liver, reducing cholesterol synthesis and prompting the liver to clear more LDL from the blood. It is a prodrug, switched on by an enzyme present in the liver but not in skeletal muscle, which is why it was developed for people who cannot tolerate statins. This page covers the 180 mg film-coated tablet, the single strength used once daily.

It is given alongside diet in adults with primary hypercholesterolaemia or mixed dyslipidaemia, alone or with a statin or ezetimibe; a fixed combination with ezetimibe also exists. The US label now also covers cutting cardiovascular risk in suitable patients. One tablet is taken daily with or without food. It can raise uric acid and has been linked to gout, and tendon rupture has been reported. Because it increases simvastatin and pravastatin exposure, labels cap those statin doses.

Sourcing notes. Bempedoic acid is a newer molecule, so patent and data protection decide whether a generic can be registered and sold in each market. Check this before planning a launch. It is prescription-only. Ask for a CTD or ACTD dossier with bioequivalence data and zone IVb stability for tropical climates. Tablets usually come in blisters or HDPE bottles at room temperature, with no cold chain. Request a batch CoA, the site GMP certificate and a CoPP where one can be issued. State the intended market, pack size, volume and label language.

Bempedoic Acid Tablets — third party manufacturing & bulk supply

Bempedoic Acid Tablets 180 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Bempedoic Acid Tablets is supplied as Tablet — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Bempedoic Acid Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Bempedoic Acid tablets is listed as Tablet in 180 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Bempedoic Acid tablets is referenced against Nexletol(US & EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.