Strides Pharma Science has ceased distribution of its ranitidine tablets in the American market as the US health regulator has asked all manufacturers to withdraw the drugs from the market immediately.
The US Food and Drug Administration (USFDA) published a statement and issued letters to all manufacturers of ranitidine across dosage forms requesting withdrawal of all prescription and over-the-counter ranitidine drugs from the market immediately.
The latest step by the regulator is based on their ongoing investigation of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine medications.
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.
