Shilpa Medicare receives tentative ANDA approval for generic Tecfidera capsule

The bulk drug manufacturer's ANDA for dimethyl fumarate delayed-release capsules was granted approval by the US drug regulator. The stock of Shilpa Medicare was buzzing on Thursday and gained 5 per cent in the morning session.

Dimethyl fumarate delayed-release capsule 120 mg & 240 mg is a generic of Tecfidera, prescribed to patients with relapsed multiple sclerosis. This ANDA was first submitted in March 27, 2017. The US market for the drug is approximately US$ 3.46 billion, as per the recent IQVIA MAT data.

Also, Shilpa Medicare has acquired 5.22 per cent stake in Prathijna Sustainable Solutions Private Limited, a captive power generation company for approximately Rs. 100 crore.

At 10:44 hours, the stock of Shilpa Medicare was quoting Rs. 388.65 per share, up by 14.65 points or 3.92 per cent on Friday, when the benchmark index BSE Sensex was upbeat at 35,516.45, up by 255.91 points or 0.73 per cent.