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About Dimethyl Fumarate API

Product
  • Therapeutic CategoryCentral Nervous System (CNS)

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Capsules

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, EUDMF, Brazil DMF, China DMF

Mechanism of Action

The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown. DMF and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro.

Indication

TECFIDERA is indicated for the treatment of patients with relapsing forms of multiple sclerosis

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Dimethyl Fumarate API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Dimethyl Fumarate API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

RFQ Form

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FAQs

How do you store Dimethyl Fumarate API?
  • Store at temperature  2 – 8°C

What is the use of Dimethyl Fumarate?
  • Dimethyl fumarate is used to treat adults with relapsing forms of multiple sclerosis

What precautions need to be taken while having Dimethyl Fumarate?
  • Avoid being near people who are sick or have infections while you are using this medicine.

What is the dosage form available for Dimethyl Fumarate API ?
  • Dimethyl fumarate is available in capsule dosage form with 120 and 240 mg

What polymorph form is available for Dimethyl fumarate?
  • We offer Crystalline Form of Dimethyl Fumarate

What is the BCS classification for Dimethyl fumarate?
Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.
Dimethyl Fumarate API Manufacturer and Supplier | CAS 624-49-7  - Dr. Reddy's