SMS Lifesciences India announced that the company has been manufacturing Ranitidine HCL (API) since 1990 and currently selling it to various markets except for USA (USDMF grade) and EU (CEP grade).
Recently, USFDA and EMA have become aware of the presence of NDMA (N-Nitrosodimethylamine), a carcinogenic impurity, at low levels in some Ranitidine API products. USFDA in a statement on 13 September, informed that they are evaluating the presence of this impurity and the impact (if any) of this impurity on patients.
Since, the company is one of the major manufacturers of Ranitidine API in the world, the company is evaluating its own Ranitidine product and its processes to ensure that its API is void of this NDMA impurity or are within permissible limits.
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