Shipla Medicare receives approval for Dimethyl Fumarate delayed Release Capsules

shilpa medicare ltdShilpa Medicare ANDA for Dimethyl Fumarate Delayed Release Capsules 120 mg & 240 mg has been granted tentative approval by FDA.
Dimenthyl 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.