Cimetidine Tablets 400mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 400mg

Reference Brands: Tagamet (US/EU)

Category: Gastrointestinal Drugs

Cimetidine 400 mg film-coated tablets, an H2-receptor antagonist for ulcer and reflux care. For importers, distributors, pharmacies and tender buyers who need an oral acid suppressant with full registration documents.

Product Description:

Cimetidine was the first histamine H2-receptor antagonist. It blocks histamine at the H2 receptors of the stomach's parietal cells, cutting both resting and meal-stimulated acid secretion. This page covers 400 mg tablets, usually film-coated. The tablet is the everyday form for outpatients: it allows a twice-daily regimen, and two tablets make the 800 mg bedtime dose often used for ulcer healing. Smaller strengths are sold without prescription in some markets for heartburn.

Uses include benign gastric and duodenal ulcers, reflux oesophagitis, persistent dyspepsia and Zollinger-Ellison syndrome. Proton pump inhibitors have taken over much of this ground, but cimetidine stays on many formularies. The point every pharmacist checks is interactions: cimetidine inhibits several cytochrome P450 enzymes and raises levels of warfarin, phenytoin and theophylline, unlike famotidine. Doses are cut in renal impairment, and long high-dose courses can cause gynaecomastia. Gastric cancer should be excluded before a gastric ulcer is managed with acid suppression.

Sourcing notes. Cimetidine 400 mg is prescription-only in most markets. Ask for a CTD or ACTD dossier. Cimetidine is generally classed as BCS class III, so some regulators accept a dissolution-based biowaiver in place of a bioequivalence study, while others do not. Ask for zone IVb stability. Blisters and HDPE bottles at room temperature are common. Request the CoA, GMP certificate and CoPP, plus a nitrosamine risk assessment covering the API. In an enquiry, give pack format, quantity, leaflet language and the remaining shelf life you need.