LAHORE: Pharmaceutical company GlaxoSmithKline Pakistan Limited (GSK) has decided to discontinue the manufacture and supply of the Ranitidine brand (Zantac), informed the company in a statement to the Pakistan Stock Exchange on Tuesday.
As noted by the European Medicines Agency (EMA), there are alternatives medicines to Ranitidine available, the statement added.
The company in its statement elaborated that it was contacted by regulatory authorities regarding the detection of N-nitrosodimethylamine (NDMA) in Zantac (Ranitidine) products. Based on the information received and correspondence with regulatory authorities, GSK made the decision in September 2019 and extended it in October 2019, to initiate a voluntary pharmacy/retail level recall in all markets of Zantac products manufactured using all API sources, as a precautionary action.
“The recall also applied to all Zantac products manufactured in Pakistan. GSK continued to respond to the queries received from the regulatory authorities and to work actively with them to address their concerns. GSK has been conducting investigations into the potential source of the NDMA,” the statement added.