Strides Pharma Science hit a 52-week low of Rs 309 per share, down 6 per cent on the BSE, on Friday after the company announced suspension of sales of Ranitidine tablet in the US market.
“While the company conducts the relevant tests mandated by the United States Food and Drug Administration (US FDA), it has suspended sales of ranitidine tablets in the US market until such time it has clarity of next steps as would be indicated by the USFDA,” Strides Pharma said in a regulatory filing today. READ FILING HERE
On Wednesday, the company informed the exchanges about the receipt of an Information Request from the US FDA to provide test data on Ranitidine tablets in the next 30 days.
"The US FDA has learned that some Ranitidine products contain a nitrosamine impurity called N‐nitrosodimethylamine (NDMA) at low levels," the company said. NDMA, which is also found in water and foods, including meats, dairy products, and vegetables, is not expected to cause harm when ingested in very low levels.
Ranitidine tablets' global front end sales were around US $9 million in H1FY20, and is amongst the top 5 products sold by the company in the USA.
"In spite of this temporary suspension of the ranitidine supplies, the Company retains its FY20 growth outlook for the US markets," it added.
The stock of pharmaceuticals company was trading lower for the fifth straight day, slipping 14 per cent, as against a 2 per cent rise in the benchmark S&P BSE Sensex during the week.