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Ferric Derisomaltose Generics bulk supplier for pharma manufacturers

Ferric Derisomaltose Generics 100 mg/ml Suppliers & Bulk Manufacturers

Available Forms: IV Infusion

Available Strengths: 100 mg/ml

Reference Brands: Monoferric® (U.S.) and Monofer® (EU))

Category: Anemia

Ferric derisomaltose (iron isomaltoside 1000) is an intravenous iron that can replace a full iron deficit in a single infusion of up to 20 mg/kg. It is used for iron-deficiency anaemia when oral iron does not work or is not tolerated, including in kidney disease and pregnancy. Reference brands are Monofer (EU) and Monoferric (US). Ask PharmaTradz for a quote; we confirm the manufacturer, registration documents and lead time for your country.

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Product Description:

Ferric Derisomaltose, marketed as Monoferric® in the U.S. and Monofer® in the EU, is a next-generation intravenous iron therapy used for treating iron deficiency anemia in adults, particularly when oral iron is ineffective or not tolerated. Its high-concentration formulation (200 mg/mL) allows for single high-dose administration, improving patient compliance and reducing treatment time. In the pharmaceutical B2B market, Ferric Derisomaltose is in high demand across hospitals, dialysis centers, and specialty clinics. In both the U.S. and EU, it is supplied under GMP conditions for institutional supply, private labeling, and international distribution through licensed manufacturers and contract partners

Ferric Derisomaltose Generics — third party manufacturing & bulk supply

Ferric Derisomaltose Generics 100 mg/ml 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

Ferric Derisomaltose Generics is supplied as IV Infusion — an injectable dosage form, so the indicative MOQ is 50,000 units. 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 Ferric Derisomaltose Generics 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

Ferric Derisomaltose is used to treat iron-deficiency anaemia in patients who cannot tolerate oral iron or require rapid iron replacement. It helps restore depleted iron stores and improves haemoglobin levels efficiently.

It is made from a stable iron–carbohydrate complex consisting of ferric iron bound to a derisomaltose (isomaltoside) polymer, allowing gradual and controlled iron release in the body.

Its main trade name is Monofer in many global markets.

It is manufactured by Pharmacosmos.

The generic name is Ferric Derisomaltose.

The brand name is Monofer.

It is manufactured primarily in Denmark by Pharmacosmos and supplied to various international markets.

Up to 20 mg/kg body weight in a single infusion, over at least 15–20 minutes, which often corrects the whole iron deficit in one visit.

Both allow high single doses. Ferric derisomaltose is associated with less low blood phosphate (hypophosphataemia) in comparative studies.

100 mg/ml solution in 1 ml, 5 ml and 10 ml vials, stored at room temperature.

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