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Shilpa Medicare Ltd. - Announcement Under Regulation 30 SEBI (LODR) 2015

| Updated on May 17, 2019 Published on May 17, 2019

This is to inform you that the Company has received U.S Food and Drug Administration 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) on 16.05.2019.
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 FDA.
According to IQVIA MAT Q1 2019 data, the US market for Docetaxel Injection USP is approximately US$ 32.13 Million.

Pdf Link: Shilpa Medicare Ltd. - Announcement Under Regulation 30 SEBI (LODR) 2015

Source : BSE - www.bseindia.com

Published on May 17, 2019
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