Shilpa Medicare receives approval for Bortezomib for Injection

Shilpa Medicare has received a tentative approval for its ANDA , Bortezomib for Injection, 3.5mg/vial from the USFDA. Bortezomib for Injection, 3.5mg/vial is a generic equivalent of reference listed drug (RLD), VELCADE used in the treatment of patients with multiple myeloma and Mantle Cell Lymphoma as recommended in the label approved by the FDA.According to IQVIA MAT Q4 2018 data, the US market for Bortezomib for Injection, 3.5mg/vial is approximately US$609 million.

On a consolidated basis, Shilpa Medicare reported sales of Rs. 173.43 crore in the quarter ended December 2018, down 6.52 per cent from Rs. 185.53 crore in the corresponding period last year. The company’s net profit stood at Rs. 12.47 crore with an EPS of Rs.1.46 per share for the quarter ended December 2018, down 27.92 per cent from Rs. 17.30 crore with an EPS of Rs. 2.29 per share YoY. The company’s EBITDA stood at at Rs. 29.30 crore in December 2018 down 9.03% from Rs. 32.21 crore in December 2017.

On Tuesday, Shilpa Medicare was trading Rs.333.30 per share, up 0.45 per cent on the BSE.