Description

Omeprazole Enteric-Coated Tablets / Capsules (10 mg / 20 mg / 40 mg)

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterological, anti-ulcerant, and mucosal-healing therapeutics. We provide ultra-high-purity, kinetically stabilized Omeprazole Enteric-Coated Pellets in Hard Gelatin Capsules / MUPS Tablets (10 mg / 20 mg / 40 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “First-in-Class Proton Pump Inhibitor (PPI)” is a massive-volume, highly lucrative export to gastroenterology clinics, internal medicine networks, retail OTC pharmacy chains, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for severe Gastroesophageal Reflux Disease (GERD), Peptic Ulcer Disease, and Helicobacter pylori eradication.

Product Overview

This highly advanced formulation contains Omeprazole, a profound acid-suppressing prodrug that fundamentally revolutionized gastroenterology by shutting down the stomach’s final pathway of acid production, allowing severe ulcers and esophageal burns to rapidly heal.

The “Acid Pump Blockade & MUPS” Specialist:

• Mechanism 1 (The H+/K+ ATPase Blockade): Once Omeprazole bypasses the stomach and is absorbed in the alkaline small intestine, it travels through the bloodstream to the highly acidic parietal cells of the stomach lining. There, it converts into its active sulfenamide form and irreversibly binds to the H+/K+ ATPase enzyme (the “proton pump”). By physically locking this pump, it halts the secretion of hydrogen ions (gastric acid) into the stomach lumen, providing a profound, 24-hour reduction in both basal and stimulated acid production.
• Mechanism 2 (The H. Pylori Eradicator): In patients with chronic stomach ulcers caused by the Helicobacter pylori bacteria, antibiotics alone frequently fail because the bacteria hides in the highly acidic stomach mucosa. Omeprazole raises the gastric pH, creating an environment where the bacteria begins to replicate, making it suddenly highly vulnerable to co-administered antibiotics (like Clarithromycin and Amoxicillin) in standard Triple Therapy protocols.
• The MUPS & Enteric Advantage (CRITICAL): Omeprazole API is completely destroyed by stomach acid before it can be absorbed. We utilize an advanced Multiple Unit Pellet System (MUPS) or encapsulated enteric-coated micro-pellets. Hundreds of individual, polymer-coated spheres disperse throughout the stomach, passing safely into the duodenum where the pH-dependent coating dissolves simultaneously, guaranteeing zero drug degradation and perfect bioavailability.

Product Composition & Strength

We supply this product as a Precision-Engineered Enteric-Coated Capsule or Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the highly acid-labile benzimidazole derivative.

*Pack Sizes: 10×10 Alu-Alu Blisters or Bottles of 100 (Optimized specifically for strict 14-to-28 day acute GI healing regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Fluid-Bed Enteric Coating Engineering: Manufacturing high-quality Omeprazole is a severe test of a facility’s coating capabilities. If the enteric coat is microscopic fractions of a millimeter too thin, the drug is destroyed in the stomach. Our facilities utilize advanced Wurster fluid-bed processors to spray a flawless, uniform layer of Methacrylic Acid Copolymer over thousands of individual sugar spheres containing the API. This is rigorously tested in dual-stage dissolution apparatuses (2 hours in acid, followed by buffer) to guarantee absolute clinical compliance.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of severe acid-related upper gastrointestinal disorders:

• Gastroesophageal Reflux Disease (GERD): Treatment of symptomatic GERD and healing of erosive esophagitis.
• Peptic Ulcer Disease (PUD): Short-term treatment of active duodenal and benign gastric ulcers.
• H. pylori Eradication: Used in combination with clarithromycin and amoxicillin (or metronidazole) for the eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence.
• Zollinger-Ellison Syndrome: Long-term treatment of pathological hypersecretory conditions.

Dosage & Administration

Recommended Dosage (Strictly as per Gastroenterologist Guidelines):

• Administration (THE BREAKFAST RULE – CRITICAL): Proton pumps are only active when a patient eats. Omeprazole MUST be taken exactly 30 to 60 minutes before the first meal of the day (breakfast) on an empty stomach. Taking it after eating drastically reduces its ability to block the pumps.
• The Intact Rule: Capsules/Tablets must be swallowed completely whole with water. They must never be chewed or crushed, as this destroys the enteric coating and renders the drug entirely useless. (For patients with feeding tubes, specific capsule contents can be mixed with acidic applesauce, strictly per physician instruction).

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Clopidogrel Interaction (BLACK BOX / SEVERE WARNING): Omeprazole is a strong inhibitor of the liver enzyme CYP2C19. This is the exact enzyme required to activate the life-saving blood thinner Clopidogrel. Co-administering these two drugs massively reduces Clopidogrel’s efficacy, leading to fatal stent thrombosis and heart attacks. An alternative PPI (like Pantoprazole or Rabeprazole) MUST be used for cardiac patients.
• Clostridium difficile-Associated Diarrhea (CDAD): By drastically lowering stomach acid (the body’s primary defense against ingested pathogens), prolonged use significantly increases the risk of severe intestinal infections, particularly C. difficile.
• Bone Fractures & Hypomagnesemia: Long-term use (over 1 year) or high-dose therapy severely impairs calcium and magnesium absorption, leading to dangerous cardiac arrhythmias and an increased risk of osteoporosis-related fractures of the hip, wrist, or spine.
• Vitamin B12 Deficiency: Daily treatment over several years can lead to severe malabsorption of cyanocobalamin (Vitamin B12) due to hypochlorhydria, potentially causing irreversible neurological damage.

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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Gastroenterological and Enteric-Coated Formulations. Whether you are looking for a reliable Government Tender Supplier for GI clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.