Strides Pharma Science has received an Information Request (IR) from the US Food and Drug Administration (USFDA) to provide test data related to N-nitrosodimethylamine (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 around $9 million in H1FY20.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
