Monomethyl fumarate bulk supplier for pharma manufacturers

Monomethyl Fumarate 95 mg, 120mg,240mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 95 mg, 120mg,240mg

Reference Brands: Bafiertam (USA), Tecfidera(USA/EU)

Category: Neurology

Monomethyl Fumarate is an oral disease-modifying agent used in the treatment of relapsing forms of multiple sclerosis (MS). It works by activating the Nrf2 pathway, which helps protect nerve cells from inflammation and oxidative stress. Monomethyl fumarate is the active metabolite of dimethyl fumarate and diroximel fumarate, offering similar therapeutic effects with potentially improved gastrointestinal tolerance.

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Product Description:

Monomethyl fumarate is the active metabolite of dimethyl fumarate. When dimethyl fumarate is taken it is rapidly hydrolysed in the gut and blood to monomethyl fumarate, which is what reaches the circulation. Giving the metabolite directly produces equivalent systemic exposure — a 190 mg dose, given as two 95 mg capsules twice daily, is bioequivalent to 240 mg of dimethyl fumarate twice daily. The aim was to reduce the gastrointestinal adverse effects associated with the parent drug.

It is used for relapsing forms of multiple sclerosis. The mechanism includes activation of the Nrf2 antioxidant pathway and a shift away from pro-inflammatory lymphocyte subsets. Flushing is very common. Lymphopenia is the key safety concern: progressive multifocal leukoencephalopathy has occurred in patients with prolonged severe lymphopenia, so lymphocyte counts are monitored and treatment is interrupted if they stay low. Liver enzymes are checked before and during treatment.

Sourcing notes. Monomethyl fumarate and dimethyl fumarate are different molecules with separate registrations and are not interchangeable at the pharmacy. Dimethyl fumarate has generic competition in major markets; monomethyl fumarate is a narrower, largely US product. A buyer asking for "fumarate" for multiple sclerosis should confirm which molecule is registered in the destination market before a quotation is prepared.

Monomethyl Fumarate — third party manufacturing & bulk supply

Monomethyl Fumarate 95 mg, 120mg,240mg 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

Monomethyl Fumarate is supplied as Capsules — an oral solid dosage form, so the indicative MOQ is 200,000 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 Monomethyl Fumarate 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

Monomethyl fumarate is listed as Capsules in 95 mg, 120mg,240mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Monomethyl fumarate is referenced against Bafiertam (USA), Tecfidera(USA/EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.