Simvastatin tablets bulk supplier for pharma manufacturers

Simvastatin Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: 5 mg, 10 mg, 20 mg, 40 mg, 80 mg

Reference Brands: Zocor (US & EU)

Simvastatin film-coated tablets 5 mg to 80 mg, a prescription statin for high cholesterol and cardiovascular risk. For importers, distributors, hospitals and public tender buyers sourcing registered stock.

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Product Description:

Simvastatin is a statin, an HMG-CoA reductase inhibitor. It slows the liver enzyme that makes cholesterol, so liver cells pull more LDL cholesterol out of the blood. Simvastatin is given as an inactive lactone that the body converts to its active acid. It is on the WHO Model List of Essential Medicines as a representative statin. This page lists film-coated tablets of 5 mg, 10 mg, 20 mg, 40 mg and 80 mg. Low strengths suit patients on interacting drugs.

Simvastatin is used for primary hypercholesterolaemia and mixed dyslipidaemia, and to lower cardiovascular risk in people with heart disease, diabetes or other high-risk conditions. The 80 mg dose carries a higher risk of muscle damage and is now restricted in many labels to patients who have taken it long-term without problems. Strong CYP3A4 inhibitors such as clarithromycin, itraconazole and HIV protease inhibitors are contraindicated, and gemfibrozil and ciclosporin are avoided. Dose limits apply with amlodipine, amiodarone, diltiazem and verapamil. Grapefruit juice should be avoided, and it is not used in pregnancy.

Sourcing notes. Simvastatin tablets are prescription-only in most countries, though a few allow low-dose pharmacy sale. Ask for a CTD or ACTD dossier with bioequivalence data and Zone IVb stability. The molecule oxidises, so formulations usually contain an antioxidant; check related substances through shelf life. Alu-alu or PVC/PVDC blisters are typical, stored below 30 °C. Request a CoA per batch, the GMP certificate and a CoPP. State strengths, pack size and target market in your enquiry.

Simvastatin Tablets — third party manufacturing & bulk supply

Simvastatin Tablets 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

Simvastatin 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 Simvastatin 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

Simvastatin is used to lower high cholesterol levels, including LDL cholesterol and triglycerides, while increasing HDL cholesterol. It helps reduce the risk of heart attack, stroke, and other cardiovascular diseases.

Simvastatin is a synthetic statin that works by inhibiting the HMG-CoA reductase enzyme in the liver, which is responsible for cholesterol production.

The primary trade name is Zocor, along with many generic brands available worldwide.

Simvastatin was originally developed and marketed by Merck & Co. and is now manufactured by multiple pharmaceutical companies globally as a generic medicine.

The generic name is Simvastatin.

Brand names include Zocor and various other regional generic brands.

Simvastatin is manufactured globally in countries such as the United States, Europe, India, and others by multiple pharmaceutical companies under approved regulatory standards.