The company has received US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA), Gemcitabine for injection USP in the strengths of 200 mg/vial and 1 g/vial, Shilpa Medicare said in a BSE filing.
Gemcitabine for injection USP is used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and pancreatic cancer.
Quoting IQVIA MAT data for December 2018, Shilpa Medicare said, the US market for Gemcitabine for injection USP, 200 mg/vial and 1 g/vlal is approximately USD 11.7 million.
Shares of Shilpa Medicare were trading 2.19 percent up at Rs 359 apiece on BSE.
source: moneycontrol