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PPIs + Clarithromycin + Amoxicillin tablets bulk supplier for pharma manufacturers

Ppis + Clarithromycin + Amoxicillin Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: (PPI): 30 mg + Amoxicillin: 500 mg + Clarithromycin: 500 mg

Reference Brands: Prevpac(US)

Category: Gastrointestinal Drugs

PPIs bind to stomach H+/K+ ATPase enzymes, reducing acid secretion, creating a less hospitable environment for H. pylori. Clarithromycin and Amoxicillin target and eliminate the bacteria. The combination effectively eradicates H. pylori, relieves ulcers, and prevents gastric cancer. Benefits include symptom relief, mucosal healing, and reduced recurrence. PPIs + Clarithromycin + Amoxicillin tablets is available in Tablets and strengths such as (PPI): 30 mg + Amoxicillin: 500 mg + Clarithromycin: 500 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, PPIs + Clarithromycin + Amoxicillin tablets is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

PPIs + Clarithromycin + Amoxicillin tablets can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

PPIs combined with clarithromycin and amoxicillin tablets are approved in the US by the FDA and in the EU via EMA for Helicobacter pylori eradication. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports swift approval, safe use, and worldwide availability, helping healthcare providers effectively treat H. pylori infections and prevent gastric complications globally.

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Frequently Asked Questions

PPIs, clarithromycin, and amoxicillin are used in combination therapy for the eradication of Helicobacter pylori infection associated with peptic ulcer disease. This triple therapy helps reduce stomach acid, eliminate the bacteria, and promote healing of gastric and duodenal ulcers.

This therapy contains three components: a proton pump inhibitor (such as omeprazole, lansoprazole, or esomeprazole), clarithromycin, and amoxicillin trihydrate. The proton pump inhibitor reduces stomach acid production, while clarithromycin and amoxicillin act as antibiotics to kill Helicobacter pylori bacteria.

Common trade names for this triple therapy include Helidac, Omeclamox-Pak, and other H. pylori eradication therapy packs marketed by different pharmaceutical companies.

These combination therapy packs are produced by several pharmaceutical companies worldwide. For example, Omeclamox-Pak is marketed by Cumberland Pharmaceuticals, while other manufacturers also produce similar H. pylori treatment kits.

The generic components include a proton pump inhibitor (such as omeprazole, lansoprazole, or esomeprazole), clarithromycin, and amoxicillin trihydrate.

Brand names include Omeclamox-Pak, Helidac therapy pack, and other H. pylori eradication therapy kits marketed under different brand names.

These combination therapy packs are manufactured by multiple pharmaceutical companies in various regions, including the United States, Europe, India, and other global pharmaceutical manufacturing markets.

Yes, PPIs + Clarithromycin + Amoxicillin tablets is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, PPIs + Clarithromycin + Amoxicillin tablets is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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