Shilpa Medicare gets tentative USFDA nod for Dimethyl Fumarate delayed release capsules

Quoting IQVIA MAT second quarter 2018 data, Shilpa Medicare said the US market for Dimethyl Fumarate delayed-release capsules is approximately USD 3.46 billion.

New Delhi: Shilpa Medicare Thursday said it has received tentative approval from the US health regulator for Dimethyl Fumarate delayed-release capsules, used for the treatment of relapsing forms of multiple sclerosis.

Multiple sclerosis (MS) is a demyelinating disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged. This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and sometimes psychiatric problems.

The company's abbreviated new drug application (ANDA) for Dimethyl Fumarate delayed-release capsules in the strengths of 120 mg and 240 mg has been granted tentative approval by the United States Food and Drug Administration (USFDA), Shilpa Medicare said in a BSE filing.

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Dimethyl Fumarate delayed-release capsules is a generic of Tecfidera, it added.

TECFIDERA is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of inactive ingredients.

Quoting IQVIA MAT second quarter 2018 data, Shilpa Medicare said the US market for Dimethyl Fumarate delayed-release capsules is approximately USD 3.46 billion.

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka, India. The commercial production in the SML was started in November 1989.

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