Shilpa Medicare has informed that the Company has received US Food and Drug Administration approval for its ANDA, Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial. Gemcitabine for Injection USP is a generic equivalent of reference listed drug (RLD), GEMZAR used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer & pancreatic cancer as recommended in the label approved by FDA. According to IQVIA MAT 12/2018, the US market for Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial is approximately $11.7 Million.
The above information is a part of company’s filings submitted to BSE.
