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 tablets, immediate-release 20-40 mg and extended-release 30-120 mg, an organic nitrate for long-term angina prophylaxis. For importers, distributors, hospitals and cardiology buyers.

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Product Description:

Isosorbide mononitrate is an organic nitrate. It releases nitric oxide in the vessel wall, relaxing veins more than arteries, which eases the filling load on the heart and cuts its oxygen demand. This page covers immediate-release tablets of 20 mg, 30 mg and 40 mg and extended-release tablets of 30 mg, 60 mg and 120 mg. Unlike the dinitrate, it needs no first-pass activation in the liver. The extended-release form lets one morning dose cover the day while leaving a low-nitrate period overnight.

It is used for long-term prevention of angina pectoris, not for an attack in progress, which calls for sublingual glyceryl trinitrate. Immediate-release tablets are taken twice daily in an asymmetric pattern, the second dose about seven hours after the first, to avoid nitrate tolerance. Extended-release tablets are taken each morning, not crushed or chewed. Nitrates must never be combined with PDE5 inhibitors such as sildenafil or tadalafil, or with riociguat, because blood pressure can fall dangerously.

Sourcing notes. Isosorbide mononitrate is prescription-only in most markets. Ask for a CTD or ACTD dossier for each release type, with bioequivalence data and comparative dissolution profiles for the extended-release tablets. Zone IVb stability matters in hot, humid climates. Tablets are packed in blisters or bottles at room temperature, protected from moisture. The supplier should provide a CoA with each batch, a GMP certificate and a CoPP. Because both release types share the 30 mg strength, cartons must state the release type clearly. Give release type, strength, scoring needs, pack size and shelf life on arrival.

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.