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.