Lansoprazole Delayed Release Capsules Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 15 mg and 30 mg
Reference Brands: Prevacid(US & EU)
Category:
Gastrointestinal Drugs
Lansoprazole capsules are proton pump inhibitors that irreversibly block gastric acid secretion by inhibiting the H+/K+ ATPase enzyme in stomach lining cells. They effectively treat GERD, ulcers, and Zollinger-Ellison syndrome. Benefits include symptom relief, mucosal healing, reduced acid-related complications, and improved quality of life.
Lansoprazole Delayed release Capsules is available in Capsules
and strengths such as 15 mg and 30 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, Lansoprazole Delayed release Capsules 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) |
Lansoprazole Delayed release Capsules 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.
Product Description:
Lansoprazole capsules, marketed as Prevacid, are approved in the US by the FDA and in the EU via EMA for GERD, erosive esophagitis, and Zollinger-Ellison syndrome. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety profiles, manufacturing quality, and pharmacovigilance plans. The FDA reviews detailed clinical trial and manufacturing data for timely approval, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Adherence to regional regulations supports swift approval, safe medication use, and global availability, helping millions worldwide effectively manage acid-related disorders.
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