New Delhi: Strides Pharma Science on Friday suspended the sale of Ranitidine tablets after it received an information request from the US health regulator to provide test data related to impurities in the drug. Ranitidine tablets are used to treat peptic ulcers of the stomach and intestines. Data related to N-nitrosodimethylamine impurities is to be provided to the agency in 30 days.
“While the company conducts the relevant tests mandated by the United States Food and Drug Administration (USFDA), 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 Science said in a BSE filing.
The company said it predominantly sells Ranitidine tablets in the US markets, and its front end sales globally for the product stood at $9 million in the first half of the current financial year. Ranitidine tablets is amongst the top 5 products sold by the company in the USA. Strides Pharma Science said in spite of this temporary suspension of the Ranitidine supplies, the company retains its growth outlook for the current financial year for the US markets. The company’s shares were trading 4.61 per cent lower at Rs 313.45 apiece on the BSE.