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 is available as ER and IR tablets in 20-120 mg strengths, supporting long-term angina management. Widely prescribed in both regions, it reduces myocardial oxygen demand, prevents angina attacks, and improves exercise capacity. Generic options ensure broad access.
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.
Isosorbide Mononitrate Tablet(Ir/Er) — third party manufacturing & bulk supply
Isosorbide Mononitrate Tablet(Ir/Er) is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Isosorbide Mononitrate Tablet(Ir/Er) listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Isosorbide Mononitrate Tablet(Ir/Er) →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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