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SMS Pharmaceuticals Ltd has said the impuritty levels in its Ranitidine product and process are ‘lower’ than the levels found in normal environmental contaminant.
It may be recalled that USFDA and EMA have recently found the presence of NDMA (N-Nitrosodimethylamine), a carcinogenic impurity, at low levels in some Ranitidine Active Pharmaceutical Ingredients (API) products.
“We have carried out an analysis of our Ranitidine product and processes and found that the NDMA impurity trace level, in many cases are lower than the levels found in normal environmental contaminant and is found in water and food including meat, dairy products and vegetables,” the Hyderabad-based company said in an update.
“However, we are investigating the root cause at our R&D and Plant level and we are confident that we can establish the process and control the impurity in the Ranitidine product manufacturing at our facility,” it added.
On September 13, the US drug regulator said it was evaluating the presence of this impurity and the impact (if any) of this impurity on patients.
Major companies including Dr Reddy’s Laboratories Ltd has stopped shipment of the product globally following the USFDA alert a couple of weeks ago. “When contacted for latest update on the revenue impact of the development and state of affairs, Dr Reddy’s has refused to comment.
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