Isosorbide Mononitrate Tablet(Ir/Er) Suppliers & Bulk Manufacturers
Available Forms: Tablet(IR & ER)
Available Strengths: ER: 30 mg, 60 mg, 120 mg; IR: 20 mg, 30 mg, 40 mg
Reference Brands: Imdur (US & EU)
Category: Heart Disorder
Isosorbide Mononitrate tablet(IR/ER) is available in Tablet(IR & ER) and strengths such as ER: 30 mg, 60 mg, 120 mg; IR: 20 mg, 30 mg, 40 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, Isosorbide Mononitrate tablet(IR/ER) 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) |
Isosorbide Mononitrate tablet(IR/ER) 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description:
Isosorbide mononitrate tablets, marketed as Imdur, are approved in the US by the FDA and in the EU via EMA for chronic stable angina. Regulatory approval requires a detailed dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial data and quality information 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. Ensuring compliance supports timely approval, safe use, and worldwide availability, helping patients manage angina effectively and improve their quality of life globally.
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