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Pantoprazole Enteric Coated Tablets

Pantoprazole Enteric Coated Tablets

Composition: Pantoprazole sodium equivalent to Pantoprazole 20 mg or 40 mg, depending on variant.

Usage: Acid-related disorders including gastroesophageal reflux disease (GERD) and erosive esophagitis, as authorized by local labeling.

Category: Antacid & Anti Ulcer Drugs

Therapeutic category: Proton Pump Inhibitor (PPI) / Antiulcer (not an antacid)

SKU: Pantoprazole Tablets

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

Product Information

Pantoprazole Enteric Coated Tablets is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

Product Description

Manufacturer: Healthy Life Pharma Pvt. Ltd. (facility and certification details require verification). Exporter: Healthy Inc (export credentials require verification).

1. Product Introduction

Pantoprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion. Enteric-coated, gastro-resistant tablets are designed to protect acid-sensitive pantoprazole during passage through the stomach and release it after the coating dissolves in the intestine.

This listing includes the supplied 40 mg IP generic tablet and Penta-20 / Penta-40 branded variants. Uses and dosing must follow the approved label for each destination market.

2. Product Specifications

VariantComposition per tabletDosage formStandard
Pantoprazole Tablets IP 40 mgPantoprazole Sodium IP equivalent to Pantoprazole 40 mgEnteric-coated tabletIP
Penta-20Pantoprazole Sodium Sesquihydrate equivalent to Pantoprazole 20 mgEnteric-coated tabletNot specified
Penta-40Pantoprazole Sodium Sesquihydrate equivalent to Pantoprazole 40 mgEnteric-coated tabletNot specified

Therapeutic class: PPI / Antiulcer. Salt: Pantoprazole sodium (sesquihydrate for Penta variants). Pack sizes, shelf life, tablet appearance and additional compendial claims require product-specific confirmation.

3. Manufacturing Technology

Because pantoprazole is acid labile, enteric-coated formulations require suitable protection of the drug core and validated gastro-resistant release. A seal coat may be used between the core and enteric polymer where appropriate to formulation compatibility.

Critical formulation considerations include coating integrity, acid resistance, buffer-stage dissolution, content uniformity, stability and suitable moisture-protective packaging. Specific branded polymers, equipment, humidity settings and production methods are not asserted without batch or technical documentation.

4. Quality Assurance

Product release testing is governed by the applicable registered specification and pharmacopoeial monograph. Typical tests include identity, assay, dosage-unit uniformity, related substances, acid-stage resistance, buffer-stage dissolution and stability.

Numerical acceptance criteria must be verified against the applicable method and approved product specification; generic figures such as 90–110% assay or fixed release percentages should not be published as actual batch results.

5. Pharmacology and Clinical Use

Pantoprazole inhibits the gastric parietal-cell H+/K+-ATPase proton pump, reducing basal and stimulated acid secretion. It is used for acid-related conditions such as GERD and erosive esophagitis; other indications including pathological hypersecretory states, ulcer management and combination regimens depend on local authorization and clinical guidance.

It does not neutralize existing stomach acid immediately and is not an instant-relief antacid. Treatment response, duration and suitability depend on diagnosis.

6. Export and Regulatory Support

For wholesale and third-party manufacturing enquiries, confirm the registered composition, manufacturing license, batch certificate of analysis, stability data, pack artwork, destination-country requirements and available dossier documents before making commitments.

WHO-GMP, Star Export House, COPP, FSC, CTD/ACTD availability, shipment destinations and logistics terms require documentary confirmation and are not independently verified on this page.

7. Frequently Asked Questions

Q: What is the difference between Penta-20 and Penta-40?
A: Penta-20 contains pantoprazole equivalent to 20 mg; Penta-40 contains pantoprazole equivalent to 40 mg.

Q: Can an enteric-coated tablet be crushed?
A: No. Do not crush, split or chew unless the specific product label explicitly permits it; disrupting the enteric coating may impair drug protection.

Q: Is pantoprazole an antacid?
A: No. It is a proton pump inhibitor that reduces acid production rather than directly neutralizing acid.

Q: When should it be taken?
A: Follow the specific prescribed product label. Some pantoprazole delayed-release tablet labels allow administration with or without food; do not assume a universal 30–60-minute pre-breakfast requirement.

8. Dosage and Administration

Strength and treatment duration vary by indication, age, comorbidities and approved prescribing information. Pantoprazole enteric-coated tablets should generally be swallowed whole with water. Do not crush or chew.

Do not self-prescribe for persistent symptoms. Alarm symptoms such as difficulty swallowing, gastrointestinal bleeding, unintended weight loss or persistent vomiting warrant medical assessment.

9. Side Effects and Precautions

Possible adverse effects include headache, diarrhea, nausea and abdominal discomfort. Long-term or high-dose PPI treatment can be associated with hypomagnesemia, vitamin B12 deficiency, fractures and certain infections; evaluate ongoing need periodically.

Important cautions include acute tubulointerstitial nephritis, severe cutaneous adverse reactions, lupus-related reactions, and clinically significant interactions with certain medicines. The effect on clopidogrel and other concomitant drugs should be assessed against current prescribing guidance, not described as universally risk-free.

10. Storage Instructions

Store in the original packaging and protect from moisture, following the approved product-specific temperature and storage instructions. Do not assume a universal below-25°C requirement or a 24–36-month shelf life without supporting stability data.

For healthcare professionals and product procurement reference. Confirm the current approved package insert, manufacturing credentials and export documents before publication or supply.