MSN group gets US FDA nod for dimethyl fumarate capsules

-By KI News Team | Oct. 11, 2020, 5:56 p.m.

Drug-maker MSN Group has got ANDA approval for its Dimethyl Fumarate capsule (DMF) for the treating Multiple Sclerosis (MS). It is not the solution for Multiple Sclerosis but lower the number of episodes from MS.

As per company press release “The firm is having over 100 ANDAs and 710 Drug Master Files.” The company has portfolio of 370 + APIs, 250+ Formulations, 62 CEPs, 200 dossiers covering 35 major therapies.

Dimethyl Fumarate is a prescription medicine used to treat relapsing forms of multiple sclerosis in adults. It is a first-line-treatment for treating relapsing-remitting multiple sclerosis (RRMS). The Nrf2 is required for redox homeostasis which is a target of Dimethyl Fumarate, however its exact remedial process of activity remain unknown says study.

The research also show effect of Dimethyl Fumarate on flowing monocytes and T cells in a planned longitudinal RRMS is persistent. DMF has been studies in various program in Sweden from 2014 against RRMS.

MSN has gone into a business association with Dr Reddy's for promoting the medication in the US. The medication will be accessible in 120 and 240 mg cases in bottle tally sizes of 14 and 60 containers, individually.

Few detail of compound DMF: (As per PubChem)

  • 3D Structure

  • IUPAC Name: dimethyl (E)-but-2-enedioate
  • Molecular Formula: C6H8O4
  • Physical Description: White Crystalline Powder
  • Molecular Weight: 144.12 g/mol
  • Boiling Point: 192 to 193
  • Melting Point: 103 to 104
  • Solubility: Highly soluble
  • Density: 1.37 g/cu cm at 20 °C
  • Stability: Stable under recommended storage conditions
  • Decomposition: Emits acrid smoke & fumes when heated

Side effects of DMF

  • Warmth, redness, itching, or burning of the skin
  • Diarrhea
  • Nausea
  • Vomiting
  • Heartburn