As advised in earlier notification to the Stock Exchanges on September 25, 2019, Strides Pharma Science has informed that the company has received an Information Request (IR) from the USFDA to provide test data related to Nnitrosodimethylamine (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 until such time it has clarity of next steps as would be indicated by the USFDA. The Company predominantly sells Ranitidine tablets in the US markets, and its front end sales globally for the product were $ 9 million in H1FY20. In spite of this temporary suspension of the ranitidine supplies, the Company retains its FY20 growth outlook for the US markets.
The above information is a part of company’s filings submitted to BSE.
