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dimethyl fumarate

Capsules 120 mg, 240 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Registered in
Italy
MAs available in
Italy , Spain
Comments
Reference product: Tecfidera®. DCP status: Completed
Manufacturer #15189
The company, which was founded in 1989, is involved in developing, manufacturing, and distributing a wide range of formulations for anti-infectives, cardiovascular, anti-diabetic, dermatological, and hormone treatment. The corporation has a global presence in 170 + countries, 60+ WHO-prequalified medications, and 3700+ product registrations.

Manufacturer usually replies in 26 days

dimethyl fumarate

Capsules, delayed release (DR) 120 mg, 240 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Comments
DCP approved
Manufacturer #6978
This global pharmaceutical company specializes in branded and generic medications, offering a wide range of products across various therapeutic areas including dermatology, oncology, and respiratory therapy. They prioritize quality manufacturing with GMP certifications and hold several patents for their innovative drug formulations. The company boasts a strong global presence spanning North America, Europe, Asia, Africa, Latin America, and the Middle East, with multiple manufacturing facilities strategically located in key regions. Their commitment to research and development is evident through dedicated R&D centers focused on advancing therapies and improving patient care worldwide.

Manufacturer usually replies in 45 days

dimethyl fumarate

Capsules, delayed release (DR) 120 mg, 240 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Unavailable markets
Antigua And/Or Barbuda , Argentina , Bahamas , Barbados , Belize , Bolivia , Brazil , Chile , Colombia , Costa Rica , Cuba , Dominica , Dominican Republic , Ecuador , El Salvador , Grenada , Guatemala , Guyana , Haiti , Honduras , Jamaica , Mexico , Nicaragua , Panama , Paraguay , Peru , Suriname , Uruguay , Venezuela , Vietnam
Available for
Licensing with supply
Comments
Ref. product: Tecfidera® Biogen Idec
Manufacturer #261
A pharmaceutical manufacturer based in the EU that has been selling its products in Europe for 20+ years. Main therapeutic areas include diabetes, CNL, dermatology, and oncology. Main dosage forms include solid and liquid oral, sterile dosage forms, and ointments. The company possesses 10+ manufacturing facilities that are cGMP-compliant.

Manufacturer usually replies in 20 days

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Dimethyl fumarate

Dimethyl fumarate is the fumaric acid of the methyl ester. It is named after the earth smoke plant called Fumaria officinalis. Dimethyl fumarate treats various forms of multiple sclerosis, a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) among adults. These include clinically isolated syndrome, its nerve symptom episodes that last at least 24 hours, for relapsing-remitting forms or secondary progressive forms. Dimethyl fumarate is an Nrf2 activator, whose actions decrease inflammation and prevent nerve damage caused by multiple sclerosis. It has great immunomodulatory properties while not suppressing the immune in adults. DMF is sold for psoriasis treatment and sold as an oral formulation mixed with related compounds in Germany. In the UK, it is sold as a pure oral formulation. It is sold in the U.S. as an oral formulation to treat adults with relapsing multiple sclerosis. Dimethyl fumarate is sold under the brand name Skilarence & Tecfidera, just to name a few. Walter Schweckendiek, a German chemist first used fumaric acid, as a topical formulation for psoriasis in 1959. Fumapharm, The Swiss company, brought Fumaderm, an oral formulation of Dimethyl fumarate in Germany in 1994 to treat psoriasis.

Dosage and administration

Dimethyl fumarate is sold as 30 mg and 120 mg tablets. In the treatment of multiple sclerosis, the standard adult doses are 120 mg and 240 mg, with the maximum daily dose limited to 480 mg. The user is given a starting dose of 120 mg twice a day, orally. After a week, they are given a maintenance dose of 240 mg twice a day, orally. Reductions in dose are considered for individuals who do not tolerate the maintenance dose, however, the dosage should resume within 4 weeks. If users are unable to tolerate a return to the maintenance, the treatment is discontinued.

The cost of Dimethyl fumarate

In the UK, the annual cost of treatment on Dimethyl fumarate is £17,900 year. In the USA, the consumer has to pay an average retail price of $11,646.72 for a course of annual treatment.

How does Dimethyl fumarate work?

Dimethyl fumarate's main action is immunomodulation. This results in shifting T helper cells from the Th1 and Th17 profile to a Th2 phenotype. Dimethyl fumarates reduce the production of Inflammatory cytokines by inducting proapoptotic events. It also inhibits keratinocyte proliferation, reduces the expression of adhesion molecules in addition to diminishing the inflammatory infiltrate within psoriatic plaques. It is also shown to reduce the expression of micro-RNA-2. This is essential for producing pathogenic cells in multiple sclerosis and psoriasis. DMF achieves this through cell-permeable metabolites that epigenetically regulate the expression of micro-RNA-21, which it does through metabolic- epigenetic interplay during the development of immune cells in the body.

Finding DMF Manufacturers and Suppliers:

The process of finding trusted DMF manufacturers and DMF suppliers can be made quicker and more accessible by using Pipelinepharma's online platform, a B2B marketplace that lets you finalize the deals of pharmaceutical products in a matter of a few clicks. Also, it is an easy to use an online platform to grow your business opportunities. The robust search engine makes it convenient to search for manufacturers and suppliers of DMF. The search can be further refined with industry-specific filters such as dossier type, country of origin, GMP approvals, and search criteria for Wholesaler, etc. helping to get in contact with the preferred manufacturer and supplier readily.

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