Omeprazole Capsules

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Omeprazole capsules typically contain enteric-coated pellets to prevent the stomach’s acid from breaking down the medication before it can be absorbed in the small intestine.

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Description

Omeprazole Capsules

Healthy Inc is a specialized global supplier and exporter of essential, high-volume gastrointestinal therapeutics. We provide high-purity Omeprazole Capsules (20 mg / 40 mg), manufactured in WHO–GMP certified, advanced multi-particulate pelletization facilities. This “First-in-Class Proton Pump Inhibitor” is a massive-volume, foundational export to primary care clinics, gastroenterology centers, and government health ministries in Africa, LATAM, the Middle East, and Southeast Asia, serving as the globally trusted, undisputed gold-standard intervention for Peptic Ulcer Disease (PUD), Gastroesophageal Reflux Disease (GERD), and H. pylori eradication.


Product Overview

This formulation contains Omeprazole, a highly potent substituted benzimidazole that operates as an inactive prodrug until it reaches the highly acidic environment of the stomach’s parietal cells.

The “Global Acid Suppression” Specialist:

  • Mechanism (Irreversible Proton Pump Blockade): Once absorbed in the duodenum, Omeprazole travels through the bloodstream and accumulates in the acidic secretory canaliculi of the gastric parietal cells. Here, it is protonated into its active form (a sulfenamide) which covalently and irreversibly binds to the H+/K+ ATPase enzyme system (the proton pump). This completely shuts down the final, foundational step of gastric acid secretion, regardless of whether the acid was stimulated by histamine, gastrin, or acetylcholine.
  • The H. Pylori Eradication Backbone: Omeprazole is the absolute cornerstone of “Triple Therapy” for eradicating Helicobacter pylori. By drastically raising the pH of the stomach, it allows co-administered antibiotics (like Amoxicillin and Clarithromycin) to survive in the gastric environment and effectively destroy the ulcer-causing bacteria.
  • The Cost-Effective Gold Standard: Because it is universally approved and highly off-patent, Omeprazole represents the most cost-effective, high-efficacy solution for national healthcare systems managing population-wide gastrointestinal morbidity.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule containing Enteric-Coated Micro-Pellets, packed strictly in high-barrier Alu-Alu or heavy-gauge Alu-PVC blister strips.

Active IngredientStrength & FormatPrimary Clinical Use
Omeprazole USP/BP/Ph.Eur.20 mg (Enteric-Coated Pellets)Standard Adult Dose for GERD maintenance and H. Pylori eradication regimens.
Omeprazole USP/BP/Ph.Eur.40 mg (Enteric-Coated Pellets)High-dose therapy for severe Erosive Esophagitis and Zollinger-Ellison Syndrome.
ExcipientsMethacrylic Acid Copolymer / Hypromellose / Sucrose SpheresEnteric Coating Polymer / Protective Barriers / Inert Core

*Pack Sizes: 10×10 Alu-Alu / Alu-PVC Blisters or Bulk Jars of 500/1000 Capsules for heavy institutional hospital dispensing.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Gastroenterology Distributors.

HS Code3004.90.99 (Medicaments containing other active substances)
CAS Number73590-58-6
Dosage FormHard Gelatin Capsule containing EC Pellets
PackagingAlu-Alu or Opaque Alu-PVC Blisters (CRITICAL). Omeprazole is highly sensitive to moisture, heat, and light. Substandard packaging results in rapid API degradation, turning the pellets brown/black.
StorageStore strictly below 25°C in a dry place. Protect from Light and Moisture.
CertificatesWHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

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

  • Acid-Resistant Pelletization Engineering: Omeprazole is an acid-labile drug; if exposed to stomach acid, it is instantly destroyed before it can be absorbed. Our specialized fluid-bed coating machinery applies a rigorous, multi-layer methacrylic acid enteric-coating to the micro-pellets, ensuring they pass through the highly acidic stomach unharmed and only dissolve in the alkaline environment of the duodenum.
  • Two-Stage Dissolution Validation: Rigorous dissolution testing is performed via HPLC on every batch. Stage 1 (Acid Stage) guarantees the enteric coating holds firm. Stage 2 (Buffer Stage) guarantees rapid and total release of the API in the intestines, ensuring maximum bioavailability.

Therapeutic Indications (Human Use)

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

  • Gastroesophageal Reflux Disease (GERD): Short-term and maintenance treatment of symptomatic GERD and healing of erosive esophagitis.
  • Peptic Ulcer Disease (PUD): Healing of active duodenal and benign gastric ulcers, including those induced by NSAID use.
  • Helicobacter pylori Eradication: Used in combination with appropriate antibacterial therapeutic regimens to eradicate H. pylori and reduce the risk of duodenal ulcer recurrence.
  • Hypersecretory Conditions: Long-term management of Zollinger-Ellison syndrome.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

  • Administration (TIMING IS CRITICAL): Must be taken orally, once daily, approximately 30 to 60 minutes BEFORE breakfast. The drug must be absorbed and present in the bloodstream when the parietal cells are stimulated to secrete acid by the first meal of the day.
  • Swallowing Protocol (CRITICAL): The capsule MUST be swallowed whole. (Alternatively, for dysphagia patients, the capsule can be opened and the intact pellets sprinkled on applesauce, but the pellets themselves must NEVER be chewed or crushed).

Safety Warnings (CRITICAL):

  • The Clopidogrel Interaction (BLACK BOX EQUIVALENT): Omeprazole is a strong inhibitor of the hepatic enzyme CYP2C19. It completely prevents the antiplatelet drug Clopidogrel from converting to its active form, leaving cardiac patients at massive risk for fatal stent thrombosis or heart attacks. Co-administration should be strictly avoided (Pantoprazole is the preferred safe alternative).
  • Clostridioides difficile-Associated Diarrhea: Profound, long-term acid suppression significantly increases the risk of severe intestinal infections, particularly C. difficile.
  • Hypomagnesemia & Bone Fractures: Long-term PPI use (over 1 year) is associated with severe drops in blood magnesium levels and an increased risk of osteoporosis-related fractures of the hip, wrist, or spine.

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 Advanced Gastroenterology Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Ministry of Health 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.

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