In the pharmaceutical industry, Cimetidine 400 mg is the pioneer H2-receptor antagonist (H2RA) used to suppress gastric acid secretion. While newer proton pump inhibitors (PPIs) have gained popularity, Cimetidine remains a vital, cost-effective therapeutic option for managing acid-peptic disorders, especially in international markets where affordability is a priority.

Primary Clinical Uses

• Duodenal and Gastric Ulcers: Indicated for the short-term treatment of active ulcers and as maintenance therapy to prevent recurrence.

• Gastroesophageal Reflux Disease (GERD): Relieves symptoms like heartburn and acid regurgitation caused by the backflow of stomach acid into the esophagus.

• Zollinger-Ellison Syndrome: Manages pathological hypersecretory conditions where the stomach produces excessive amounts of acid.

• Prophylaxis of GI Bleeding: Used in critical care settings to prevent stress-induced ulcers and upper gastrointestinal bleeding.

• Off-label Dermatological Use: Occasionally used in high doses for the treatment of viral warts (verrucae) due to its immunomodulatory properties.

  Mechanism of Action

Cimetidine works by competitively inhibiting histamine at the H2-receptors located on the basolateral membrane of the gastric parietal cells.

By blocking these receptors, it inhibits both the basal (fasting) and stimulated (food-induced) secretion of gastric acid. This results in a significant reduction in the volume of gastric juice and its hydrogen ion concentration, allowing the mucosal lining to heal.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Cimetidine 400 mg is a high-volume, “essential medicine” staple:

• Drug-Drug Interactions (CYP450): As a pharmacist, you know Cimetidine is a potent inhibitor of several cytochrome P450 enzymes (e.g., 1A2, 2C9, 2D6). In our professional labeling and dossiers, we emphasize these interactions to ensure patient safety when co-administered with drugs like Warfarin or Theophylline.

• Stability for Global Markets: Cimetidine is a stable molecule, but as a WHO-GMP manufacturer, we utilize PVC/PVDC or Alu-Alu blister packaging to ensure its 36-month shelf life remains intact during export to Zone IVb climates (Africa, SE Asia, and Latin America).

• B2B & Public Health Tenders: Because Cimetidine is often more affordable than modern PPIs, it remains a high-demand item for government health tenders and low-cost B2B distribution networks.

• Regulatory Readiness: Our Mumbai-based facility provides comprehensive CTD/eCTD Dossiers and stability data (BP/USP/IP) to facilitate rapid registration for our international partners.