Description

Ranitidine Injection

Healthy Inc is a specialized global supplier and exporter of essential gastrointestinal therapies. We provide high-purity, strictly compliant Ranitidine Injection (50 mg / 2 ml), manufactured in WHO–GMP certified sterile facilities. This “H2 Blocker” is a mandatory export to surgical wards, gastroenterology clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a rapid intervention for gastric acid suppression and prophylaxis against acid aspiration during anesthesia.

Product Overview

This formulation contains Ranitidine Hydrochloride, a reversible, competitive antagonist of the histamine H2 receptor.

The “Histamine Blocker” Specialist:

• Mechanism (H2 Antagonism): Ranitidine highly selectively blocks histamine from binding to H2 receptors located on the basolateral membrane of gastric parietal cells. By doing so, it interrupts the cAMP-dependent pathway, significantly reducing both the volume and the hydrogen ion concentration (acidity) of basal, nocturnal, and food-stimulated gastric acid secretion.
• Pre-Surgical Prophylaxis: Administered pre-operatively to raise gastric pH and lower gastric volume, effectively protecting the patient from Mendelson’s syndrome (severe pneumonitis caused by pulmonary aspiration of acidic gastric contents during general anesthesia).
• Mucosal Healing: Creates an optimal low-acid environment that allows bleeding peptic and duodenal ulcers to heal rapidly when oral therapy is not feasible.

Product Composition & Strength

We supply this product as a Sterile, Clear, Aqueous Solution in glass ampoules.

*Pack Sizes: Tray of 10 Ampoules, 50 Ampoules, or 100 Ampoules.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority & Compliance

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Strict NDMA Purity Protocols: In response to global regulatory standards regarding N-Nitrosodimethylamine (NDMA) impurities in Ranitidine products, our manufacturing utilizes exclusively certified APIs. We employ LC-MS/MS (Liquid Chromatography-Mass Spectrometry) testing on both the raw API and the finished batch to guarantee NDMA levels remain strictly below the FDA/EMA acceptable intake limits.
• Nitrogen Purging: Ampoules are sealed under a nitrogen blanket to eliminate oxygen headspace, preventing oxidative degradation and ensuring absolute molecular stability throughout the product’s shelf life.

Therapeutic Indications (Human Use)

Indicated for the short-term treatment of gastric disorders where oral therapy is inappropriate:

• Duodenal and Benign Gastric Ulcers: Including those associated with NSAID therapy.
• Zollinger-Ellison Syndrome: Management of pathological hypersecretory conditions.
• GERD: Severe gastroesophageal reflux disease.
• Aspiration Prophylaxis: Prevention of acid aspiration syndrome (Mendelson’s syndrome) during obstetric delivery or general anesthesia.
• Stress Ulceration: Prophylaxis of GI hemorrhage from stress ulceration in seriously ill ICU patients.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

• Route: Intramuscular (IM), Slow Intravenous (IV) Injection, or IV Infusion.
• Standard Adult Dose: 50 mg IM or IV every 6 to 8 hours.
• Slow IV Bolus Warning: If given as a direct IV injection, the 50 mg dose MUST be diluted to a volume of 20 ml (with normal saline or dextrose) and injected very slowly over at least 5 minutes.
• Prophylaxis of Mendelson’s Syndrome: 50 mg IM or slow IV 45 to 60 minutes prior to induction of general anesthesia.
• Renal Impairment: Dose must be reduced to 50 mg every 18 to 24 hours in patients with severe renal failure (Creatinine Clearance < 50 ml/min).

Safety Warnings (CRITICAL):

• Cardiovascular Effects: Rapid IV administration of Ranitidine can cause bradycardia, arrhythmias, and sudden hypotension. Never push rapidly.
• Hepatic Toxicity: Transient and reversible changes in liver function tests can occur. Discontinue if signs of hepatitis (jaundice) appear.
• Masking Malignancy: Symptomatic relief with Ranitidine does not preclude the presence of gastric malignancy. Rule out cancer prior to initiating therapy for gastric ulcers.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Gastrointestinal Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.