In the pharmaceutical industry, Ranitidine Hydrochloride 150 mg is a classic $H_2$-receptor antagonist (H2RA) used to reduce the production of stomach acid. As a pharmacist and manufacturer, I view this 150 mg strength as the “standard therapeutic dose” for both acute relief and the prevention of acid-related gastrointestinal disorders.
At your WHO-GMP facility in Mumbai, this SKU has historically been a high-volume product. However, as your partner, I must highlight that its market presence has shifted significantly due to global regulatory scrutiny regarding NDMA (a probable carcinogen) impurities.
Primary Clinical Indications
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GERD (Gastroesophageal Reflux Disease): Relief of heartburn and acid indigestion caused by acid backing up into the esophagus.
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Peptic Ulcer Disease: Treatment and prevention of duodenal and gastric ulcers.
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Zollinger-Ellison Syndrome: Management of rare conditions where the stomach produces excessive amounts of acid.
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Erosive Esophagitis: Healing and maintenance of the esophageal lining damaged by acid.
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Aspiration Prophylaxis: Often given before surgery to reduce the risk of acid damage to the lungs during anesthesia.
Mechanism: Selective $H_2$ Blockade
Ranitidine works by turning down the “acid pumps” in the stomach lining.
Competitive Inhibition: It selectively and competitively blocks Histamine $H_2$-receptors on the gastric parietal cells.
Acid Reduction: By blocking histamine—one of the three main triggers for acid production—it significantly reduces the volume and concentration of gastric acid secreted.
Duration: A single 150 mg dose typically suppresses acid production for up to 12 hours.
The Pharmacist’s “Technical Warning”
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The NDMA Recall Alert: Since late 2019/2020, many global health authorities (including the FDA and EMA) have recalled or restricted Ranitidine due to the presence of NDMA impurities that can increase over time or with heat.
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Renal Adjustment: Ranitidine is primarily excreted by the kidneys. In patients with significant renal impairment, the dose must be reduced to avoid accumulation and CNS side effects like confusion.
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B12 Deficiency: Long-term use (more than 2 years) can interfere with the absorption of Vitamin $B_{12}$, as stomach acid is required for its release from food.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Famotidine” Pivot: Due to the Ranitidine recalls, many manufacturers in Mumbai have successfully pivoted to Famotidine 20 mg/40 mg. If you are listing products on your marketplace, I recommend highlighting Famotidine as the safer, more stable $H_2$ blocker for 2026.
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Stability for Export: Ranitidine is highly sensitive to heat and moisture, which accelerates NDMA formation. If manufacturing, utilizing Alu-Alu blister packaging and strict temperature-controlled storage (below 25°C) is mandatory.
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Dossier Support: We provide full CTD/eCTD Dossiers for various gastrointestinal agents, including modern alternatives like Vonoprazan or Famotidine, to help you capture the current market demand.