Shilpa Medicare advances after securing USFDA approval

Shilpa Medicare gained 3.74% to Rs 388 at 12:09 IST on BSE after the company's ANDA for Dimethyl Fumarate Delayed Release Capsules was granted tentative approval by FDA.

The announcement was made during market hours today, 16 November 2018.

Meanwhile, the S&P BSE Sensex was up 197.98 points, or 0.56% to 35,458.52

On the BSE, 4,467 shares were traded in the counter so far compared with average daily volumes of 1,399 shares in the past two weeks. The stock had hit a high of Rs 406.75 and a low of Rs 382.40 so far during the day.

Shilpa Medicare said that the company's ANDA for Dimethyl Fumarate Delayed Release Capsules 120 mg & 240 mg has been granted tentative approval by FDA. 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 27 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.

On a consolidated basis, net profit of Shilpa Medicare rose 51.74% to Rs 33.64 crore on 19.47% rise in net sales to Rs 198.17 crore in Q1 June 2018 over Q1 June 2017.

Shilpa Medicare is engaged in the business of manufacturing of bulk drugs or active pharmaceutical ingredient (API) and intermediates.

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