Esomeprazole Tablets

Esomeprazole Tablets 20 mg: Each enteric-coated tablet contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.

Esomeprazole Tablets 40 mg: Each enteric-coated tablet contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 40 mg.

Usage: Heartburn, acid reflux and gastro-oesophageal reflux disease according to approved labeling.

Category: Antacid & Antiulcer Drugs

Therapeutic Category: Proton Pump Inhibitor / Antiulcer

SKU: Esomeprazole Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

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Product Information

Esomeprazole Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Esomeprazole Tablets (20 mg / 40 mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures Esomeprazole Magnesium delayed-release tablets in India. Esomeprazole is the S-isomer of omeprazole and a proton pump inhibitor (PPI) that suppresses gastric acid secretion. It is used for gastro-oesophageal reflux disease (GERD), erosive oesophagitis and other acid-related conditions as specified in local approved labeling. Relative efficacy and duration depend on the indication, regimen and comparative evidence; superiority over other PPIs is not universal.

2. Product Specifications

Parameter	Specification
Product	Esomeprazole Magnesium delayed-release tablets
Composition	Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg or 40 mg
Strengths	20 mg / 40 mg
Dosage Form	Enteric-coated tablet
Therapeutic Class	Proton Pump Inhibitor (PPI)
Standard	Applicable USP / BP / IP or registered specification
Packaging	Blister or bottle as supported by stability studies
Shelf Life	According to validated product-specific stability data

3. Manufacturing Technology

Enteric protection: Esomeprazole is acid-sensitive; the delayed-release system is designed to protect it during passage through the stomach and release it under suitable intestinal conditions.
Stability: Moisture management, compatible excipients and protective packaging are selected based on formulation studies.
MUPS: Multi-unit pellet systems are a distinct formulation option and should only be described as available where specifically developed and registered. No automatic absorption advantage is assumed.

4. Quality Assurance

Identity, assay, content uniformity, related substances and chiral purity are evaluated under applicable validated methods.
Delayed-release dissolution is assessed using acid and buffer stages with acceptance criteria defined by the registered specification, not universal fixed percentages.
Shelf life and storage conditions require supporting stability data.

5. Pharmacology and Clinical Use

Esomeprazole inhibits gastric H+/K+-ATPase, reducing acid secretion. Approved indications can include GERD, healing or maintenance of erosive oesophagitis, selected NSAID-associated ulcer indications, H. pylori eradication in combination with appropriate antibiotics, and hypersecretory conditions. Local prescribing information governs indications and treatment.

6. Export and Regulatory Support

Product-specific CTD/ACTD documentation, bioequivalence evidence, COA, FSC and COPP may be supplied where available and applicable. Packaging and shipping arrangements depend on registered market requirements. Bioequivalence to Nexium or another reference product must not be claimed without relevant regulatory evidence.

7. Frequently Asked Questions

Who manufactures Esomeprazole Tablets?
Healthy Life Pharma Pvt. Ltd., India.

Is it Nexium?
Nexium is a brand of esomeprazole. A separate product is not automatically bioequivalent or interchangeable without applicable regulatory evidence.

When should I take it?
Meal timing depends on the exact registered product; many delayed-release esomeprazole products are directed to be taken before meals. Follow the prescribed label.

Can it be used long term?
Long-term therapy requires periodic medical review of the indication, dose and possible adverse effects.

8. Dosage and Administration

Indication-specific doses, frequency and treatment duration vary with the patient's condition, age, concomitant medicines and registered labeling. Delayed-release tablets generally should not be crushed or chewed; follow product-specific administration instructions, including any approved dispersion method.

9. Side Effects and Precautions

Common: Headache, abdominal discomfort, nausea, diarrhoea or constipation.
Serious risks: Severe allergic reactions, kidney inflammation and C. difficile-associated diarrhoea may occur.
Long-term use: May be associated with low magnesium, vitamin B12 deficiency and fracture risk in selected patients; assess based on clinical circumstances.
Interactions: Esomeprazole can reduce activation of clopidogrel; concomitant use is generally discouraged by relevant prescribing guidance. Review other medicines, including drugs affected by gastric pH and certain antiretrovirals.

10. Storage Instructions

Store at the temperature specified on the approved label, protected from moisture and excessive heat. Keep in original protective packaging and out of reach of children.