NEW DELHI: Pharmaceutical major Strides Pharma Science announced on Friday that it is temporarily suspending the sale of Ranitidine tablets in the US, following an information request for test data from the US Food and Drug Administrator (USFDA).
Several major drug manufacturers have halted supplies of Ranitidine products and implemented large scale recalls after the detection of more than accepted levels of cancer-causing Nnitrosodimethylamine (NDMA) impurities.
The announcement saw Strides Pharma shares tanking sharply on the stock markets, with the stock closing at Rs 304.2 on the BSE, down 7.43 per cent compared to Thursday, a six-year end-of-day low.
“Strides has received an Information Request (IR) from the USFDA to provide test data related to NDMA impurities in Ranitidine tablets. This data is to be provided to the agency in 30 days. While the company conducts the relevant tests mandated by the USFDA, it has suspended sales of Ranitidine tablets in the US market..,” the firm said.
Pharmaceutical majors like GlaxoSmithKilne and Dr Reddy’s, alongside several other Ranitidine suppliers, have already announced suspension of Ranitidine products until such tests could be completed.
For Strides Pharma, the suspension may have a substantial effect on sales, since Ranitidine is among its top five sellers in the US market. According to the company, it “predominantly sells Ranitidine tablets in the US markets, and (its) front end sales globally for the product were approximately $9 million” (around Rs 6.34 crore) during the first half of the current financial year (FY2019-20).
The firm’s annual report for the FY2018-19 shows that the US accounted for 35 per cent of the Rs 245.3 crore sales it recorded in regulated markets during the year. “In spite of this temporary suspension of the Ranitidine supplies, it retains its FY20 growth outlook for the US markets,” Strides said.