Home / BUSINESS / Shilpa Medicare gets tentative ANDA approval for Dimethyl Fumarate DR Capsules

Shilpa Medicare gets tentative ANDA approval for Dimethyl Fumarate DR Capsules

Shilpa Medicare has received tentative approval for its ANDA for Dimethyl Fumarate Delayed Release Capsules 120 mg & 240 mg. from USFDA. Dimethyl Fumarate Delayed Release Capsules 120 mg & 240 mg is a generic of TECFIDERA, used in the treatment of patients with relapsing forms of multiple sclerosis.

This ANDA is a first to file submission made on NCE-1 dated March 27, 2017. USFDA review process was completed and got approval within a period of 19.5 months from the date of submission.

According to IQVIA MAT Q2 2018 data, the US market for Dimethyl Fumarate DR Capsules is around $3.46 billion.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.

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