Shilpa Medicare has received tentative approval from USFDA for its ANDA for Dimethyl Fumarate Delayed Release Capsules 120 mg & 240 mg.

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. FDA 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 approximately USD 3.46 billion.

Shares of the company gained Rs 18.5, or 4.95%, to trade at Rs 392.50. The total volume of shares traded was 334 at the BSE (9.53 a.m., Friday).