regulators seek drug testing data from pharma cos
WEB DESK
Pharma company GlaxoSmithKline Pharmaceuticals (GSK) on September 25 said it has suspended the release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations.
GSK sells Ranitidine Hydrochloride tablets under popular brand name Zinetac in India.
GSK said it has been contacted by regulatory authorities regarding the detection of nitrosamine impurity called N‐nitrosodimethylamine (NDMA) in ranitidine products. NDMA has been classified by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans.
GSK made the decision based on the information received and correspondence with regulatory authorities, the company said.
“GSK is continuing with investigations into the potential source of the NDMA. These investigations include continued engagement with our API suppliers. Patient safety remains our utmost priority and we are taking this issue very seriously,” the company said.