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Pakistan

GSK to no more manufacture and supply Zantac, after NDMA detected

GSK was contacted by regulatory authorities regarding the detection of N-nitrosodimethylamine (NDMA) in Zantac (Ran
19 May 2020
  • GSK was contacted by regulatory authorities regarding the detection of N-nitrosodimethylamine (NDMA) in Zantac (Ranitidine) products.

Pharmaceutical giant, GlaxoSmithKline on Tuesday announced that it would discontinue the manufacture and supply of the Ranitidine brand (Zantac).

In a statement issued to the Pakistan Stock Exchange (PSX) informed that GSK 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,” read the statement.

“The recall also applied to all Zantac products manufactured in Pakistan,” it added.

The company informed that it has been conducting investigations into the potential source of the NDMA.

“We are, through this letter, informing you about a decision that has been made by GSK to discontinue the manufacture and supply of the Ranitidine brand (” Zantac”).  As noted by the European Medicines Agency (EMA), there are alternatives medicines to Ranitidine available,” the company added.