Domperidone & Famotidine Tablets

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Product Composition & Strength

We supply this product as a Precision-Blended, Rapid-Release FDC Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of both active pharmaceutical ingredients.

Active IngredientStrengthPrimary Clinical Function
Domperidone Maleate USP/Ph.Eur.10 mgThe Antiemetic/Prokinetic Anchor: The micro-dose peripheral D2 antagonist required to halt nausea and rapidly accelerate gastric emptying.
Famotidine USP/Ph.Eur.20 mgThe Acid Suppressor (NDMA-Free): The highly potent, structurally stable H2-receptor antagonist required to crush basal and food-stimulated gastric acid secretion.
ExcipientsMicrocrystalline Cellulose / Sodium Starch Glycolate / Povidone K-30 / Magnesium Stearate / Premium Polymeric FilmDiluent / Superdisintegrant / Binder / Lubricant / Heavy Film-Coating (Engineered specifically utilizing advanced rapid-burst disintegrants to ensure the tablet dissolves instantly in the stomach for fast relief, heavily coated to protect the APIs from environmental degradation)

*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for high-volume, rapid-turnover acute GI dispensing).

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Description

Domperidone & Famotidine Tablets 

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterology, prokinetic, and highly stabilized acid-suppression therapeutics. We provide ultra-high-purity, kinetically synchronized Domperidone & Famotidine Film-Coated Tablets (10 mg / 20 mg), manufactured in WHO–GMP certified, NDMA-free, high-precision oral solid dosage facilities. This “Prokinetic & Next-Generation H2-Receptor Antagonist FDC” is a massive-volume, highly lucrative export to gastroenterology networks, acute dyspepsia clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, 100% legally compliant replacement for banned Ranitidine-based combinations in the treatment of Gastroesophageal Reflux Disease (GERD) and severe indigestion.


Product Overview

This highly advanced formulation operates as a coordinated, dual-action rescue agent for the upper gastrointestinal tract. It provides the exact clinical relief profile of the older Ranitidine combinations—suppressing stomach acid and physically clearing the stomach—but utilizes a vastly superior, structurally stable H2-blocker that does not degrade into carcinogenic impurities.

The “NDMA-Free Acid Suppressor & Peripheral Prokinetic” Specialist:

  • Mechanism 1 (The Basal Acid Shutdown – Famotidine): Famotidine is a highly potent, competitive antagonist of histamine H2-receptors located on the basolateral membrane of the gastric parietal cells. By blocking histamine from binding, it severely blunts the stomach’s ability to produce acid, particularly highly effective at shutting down “basal” (nighttime) acid secretion. Milligram for milligram, Famotidine is nearly 9 times more potent than Ranitidine.
  • Mechanism 2 (The Gastric Clearing Drive – Domperidone): Lowering acid is only half the battle in GERD; the stomach must also be emptied to prevent upward pressure. Domperidone acts as a highly selective peripheral D2-receptor antagonist. It blocks dopamine in the upper GI tract, which violently accelerates gastric motility, tightens the Lower Esophageal Sphincter (LES), and physically pushes the stomach contents into the intestines, instantly relieving bloating and nausea.
  • The “Carcinogen-Free” Structural Advantage: Unlike Ranitidine, Famotidine’s molecular structure does not contain the unstable dimethylamine group necessary to form N-Nitrosodimethylamine (NDMA). This guarantees absolute chemical stability and patient safety, allowing for massive international export without fear of regulatory recalls or FDA/EMA bans.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Gastroenterology Distributors, and Hospital Procurement Boards.

HS Code3004.90.99 (Medicaments containing other active substances – Gastroenterology/H2 Blockers & Prokinetics)
CAS Numbers57808-66-9 (Domperidone) / 76824-35-6 (Famotidine)
Dosage FormFilm-Coated Tablet (Immediate Gastric Release)
PackagingHigh-Density Alu-Alu Blisters (STRICTLY MANDATORY). Ensures the physical integrity of the fast-acting tablet and protects the formulation from environmental humidity across Zone IVb tropical climates.
Export Compliance100% Globally Compliant. Free from all FDA, EMA, and WHO alerts regarding NDMA contamination, ensuring frictionless cross-border logistics.

Manufacturing Authority

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

  • NDMA-Free Certification & Cardiac Impurity Profiling (CRITICAL COMPLIANCE): Our GI suites operate under the strictest international mandates. We utilize advanced gas chromatography-mass spectrometry (GC-MS) to certify that our Famotidine supply chain is completely devoid of nitrosamine impurities. Furthermore, we guarantee zero cardiotoxic impurities in our Domperidone blending, ensuring absolute compliance with European Medicines Agency (EMA) cardiac safety limits. We provide global buyers with an impenetrable, liability-free product.

Therapeutic Indications (Human Use)

Indicated for the targeted, rapid management of acid-peptic disorders and gastrointestinal dysmotility:

  • Gastroesophageal Reflux Disease (GERD): Treatment of symptomatic GERD, non-erosive reflux disease, and acid regurgitation complicated by delayed gastric emptying.
  • Non-Ulcer Dyspepsia: Relief of upper abdominal discomfort, bloating, early satiety, and nausea.
  • Peptic Ulcer Disease (Adjunct): Short-term management of benign gastric and duodenal ulcers where acid suppression is required.

Dosage & Administration

Recommended Dosage (Strictly as per Physician Guidelines):

  • Standard Adult Dosing: 1 tablet taken orally twice daily (BID).
  • The Pre-Meal Mandate: Must be taken 15 to 30 minutes before meals. Taking it before eating ensures the Domperidone can prime the stomach for motility and the Famotidine can block the meal-induced acid spike.
  • The Maximum Limit Mandate (CRITICAL): Due to the Domperidone component, the maximum daily dose MUST NOT exceed 30 mg of Domperidone in a 24-hour period.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • QTc Prolongation & Sudden Cardiac Death (Domperidone Alert): Domperidone is associated with an increased risk of severe cardiac arrhythmias. Strictly contraindicated in patients with known prolonged cardiac conduction intervals, heart failure, or those taking potent CYP3A4 inhibitors (e.g., Ketoconazole, Erythromycin).
  • Renal Impairment Adjustment (Famotidine): Famotidine is heavily excreted by the kidneys. In patients with severe renal impairment (creatinine clearance < 50 mL/min), the drug will accumulate to toxic levels, causing severe central nervous system adverse effects (confusion, hallucinations, seizures). Dose intervals must be strictly extended.
  • Hyperprolactinemia: Domperidone can cause prolactin levels to surge, potentially leading to galactorrhea (abnormal breast milk production) and gynecomastia.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Gastroenterology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antiemetic FDCs, NDMA-Free Acid Suppressors, and Compliant GI Formulations. Whether you are looking for a reliable Government Tender Supplier to replace banned Ranitidine stocks in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, legally secure delivery of WHO-GMP certified products

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