Isosorbide Mononitrate tablet(IR/ER) bulk supplier for pharma manufacturers

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)

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.

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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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Isosorbide Mononitrate Tablet(Ir/Er) is supplied as Tablet(IR & ER) — supplied in more than one dosage form, each with its own manufacturing economics, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and 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.

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Frequently Asked Questions

Isosorbide Mononitrate tablet(IR/ER) is listed as Tablet(IR & ER) in ER: 30 mg, 60 mg, 120 mg; IR: 20 mg, 30 mg, 40 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Isosorbide Mononitrate tablet(IR/ER) is referenced against Imdur (US & EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.