Shilpa Medicare is in the limelight today morning, going up over 6.5% at Rs.399.75 though volumes remain pretty muted.
The company stated today morning that it has received tentative ANDA approval from the FDA for Dimethyl Fumarate Delayed Release Capsules.
This is used in the treatment of patients with relapsing forms of multiple sclerosis.
This ANDA is a first to file submission made on 27th March 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 US$ 3.46 billion.