Strides Pharma suspends sale of Ranitidine tab in US
Data related to N-nitrosodimethylamine impurities is to be provided to the agency in 30 days.
Also read:-Dr Reddys suspends worldwide supply of Ranitidine over cancer fears until USFDA probe over
"While the company conducts the relevant tests mandated by the 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 USD 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.
Also read:-CDSCO warns against Cancer Causing Impurities in anti-acidity drug Ranitidine, writes to state drug controllers
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.
Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at email@example.com. Check out more about our bureau/team here