GSK announces to discontinue production of Ranitidine brand ‘Zantac’

KARACHI: Pakistani Pharmaceutical Company, GlaxoSmithKline Pakistan Limited (GSK) Tuesday announced to discontinue the production, manufacturing and supply of the Ranitidine brand (Zantac) in Pakistan, informed the company in a statement to the Pakistan Stock Exchange (PSX).

Zantac and ranitidine have made numerous headlines all over the world after the Food and Drug Administration (FDA) decided to investigate possible contaminants in ranitidine products on September 13 and companies (like CVS) chose to voluntarily suspend the sale of the heartburn medication all over the world.

The crux of the matter is a naturally-occurring compound called N-nitrosodimethylamine (NDMA), found in low (but “unacceptable”) levels in random samples of the drug tested.

According to the media news, the medicine was causing of cancer because of NDMA.

As previously communicated on 24th September 2020, GSK was contacted by regulatory authorities regarding the detection of NDMA in Zantac (Ranitidine) products. Patient safety remains GSK’s absolute priority.

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 has 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.

As noted by the European Medicines Agency (EMA), there are alternatives medicines to Ranitidine available in Pakistan and the world.

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