Shilpa Medicare gets USFDA approval for cancer injection

Shilpa Medicare informed the bourses that it has secured the USFDA's approval for Gemcitabine for injection, on Monday.

Gemcitabine injection is used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and pancreatic cancer. As per IQVIA, the market for the injection is approx US$11.7 million.

During the recent quarter Q3FY19, the company has registered 6.5 per cent decline in its topline on YoY basis. Also, the company's net profit declined by 32 per cent on YoY basis. However, its US business showed growth momentum with a rise in sales by 46 per cent YoY.

The company's total filings for the US business stood at 34 on quarter end, out of which it has received 4 final approvals and 1 tentative approval. 
  
On Monday, the stock of Shilpa Medicare rose by 3 per cent and made an intraday high of Rs. 363.40 on the BSE. At 14:05 hours, the stock was trading nearly at Rs. 355 on the BSE. The company had hit its 52-week high of Rs. 546.95 on September 14, 2018 and its 52-week low of Rs. 335 on February 19, 2019 on the BSE.