GSK suspends ranitidine hydrochloride products

GSK suspended the release, distribution and supply of all dose forms of ranitidine hydrochloride products in all markets including India after regulatory authorities detected presence of genotoxic nitrosamine NOMA in the products.

The company stated that the suspension was done as a precautionary action to the pending the outcome of ongoing tests and investigations. Saraca Laboratories Limited was notified by the European Directorate for the Quality of Medicines that its certificate of suitability for ranitidine hydrochloride has been suspended. The company is involved in manufacturing Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) by using API from Saraca Laboratories Limited and SMS Lifesciences India Limited, to supply in Indian markets. Hence, the company has initiated a voluntary recall of Zinetac Tablets 150 mg and 300 mg products manufactured using API which has been sourced from Saraca Laboratories Limited. While the company awaits the test results and continues the investigations into the potential source of the NOMA, all such products will be on hold.

GlaxoSmithKiine Pharmaceuticals Limited is a pharma company and its India product portfolio includes prescription medicines and vaccines.

On Thursday, the stock of the company closed at Rs. 1415.05, down by 1.42 per cent or Rs. 20.4 per share. The 52 week high is Rs. 1544.95 and 52 week low is Rs. 1131.05 on BSE.