The company has made a decision to discontinue the manufacture and supply of Zinetac tablets (150 mg and 300 mg products) manufactured in India and will in due course request cancellation of the marketing authorisation associated with the drug, GlaxoSmithKline Pharmaceuticals said in a regulatory filing.
In the coming months, the drug firm will work closely with the regulatory authorities, it added.
The drug firm was contacted by regulatory authorities regarding the detection of cancer causing N-Nitrosodimethylamine (NDMA) in Zinetac (ranitidine) products.
Based on the information received and correspondence with regulatory authorities, the company made the decision in September 2019 to initiate a voluntary recall of all ranitidine products in all markets of as a precautionary action. PTI MSS SHW SHW
Disclaimer :- This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: PTI