GSK to discontinue the manufacture and supply of Zantac products

May 18, 2020 (MLN): GlaxoSmithKline has decided to discontinue the manufacture and supply of the Ranitidine brand (Zantac).

Last year, the company was contacted by regulatory authorities regarding the detection of 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. It also conducted investigations into the potential source of the NDMA.

With the discontinuation of Zantac’s manufacture, the company has informed that there are alternatives medicines to Ranitidine available, as noted by the European Medicines Agency (EMA).

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Posted on: 2020-05-19T11:31:00+05:00