Shilpa Medicare surges on receipt of USFDA approval

Shilpa Medicare informed in a press release that it has received approval from the US regulator for its ANDA, Docetaxel injection on Friday. The stock reacted positively and touched intra-day high of Rs 386 on the BSE.
 
The company received the US Food and Drug Administration’s (USFDA) final approval for its ANDA, Docetaxel injection USP, 20 mg/mL, 80 mg/4 mL (20 mg/mL), and 160 mg/8 mL (20 mg/mL). Docetaxel injection USP, 20 mg/mL, 80 mg/4 mL and 160 mg/8 mL is a generic equivalent of reference listed drug (RLD) taxotere used in the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, head and neck cancer as recommended in the label approved by the USFDA. According to IQVIA MAT Q1 2019 data, the US market for Docetaxel injection USP is approximately $32.13 million.
 
Shilpa Medicare in engaged in manufacturing and selling active pharmaceutical ingredients fine chemicals, intermediates, herbal products and speciality chemical products as per international specifications.
 
Stock closed at Rs. 374.75, higher by 0.29 per cent than its previous close.