GlaxoSmithKline Pharma is in the red today, going down to an intra day low at Rs.1385, a fall of over 3.5%. The stock has been falling over the last two days, losing 4.7% in this period. It has underperformed the sector by over 3%.
The stock tanked after the company said that it has been contacted by regulatory authorities regarding the detection of genotoxic nitrosamine NDMA in ranitidine products – based on which, GSK decided to suspend 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. Genotoxic nitrosamine NDMA is known to cause cancer.
Ranitidine medicines are used to treat stomach acidity and heartburn and are both over-the-counter and prescription drugs.
European Directorate for the Quality of Medicines (EDQM) has suspended the certificate of suitability of its supplier Saraca Laboratories Ltd for ranitidine hydrochloride with immediate effect.
The company makes Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg under its brand Zinetac using API from Saraca Laboratories Ltd and another supplier, SMS Lifesciences India Ltd, for supply to Indian market.
The US FDA, on 13th Sept sent out an alert stating the low-level presence of NDMA, a known carcinogen, in ranitidine. After the FDA, our drug regulator, Drug Controller General (India) also got into testing the antacid for the impurity.
The company said that all such products will remain on hold and they will not be released to the market while the company will await the test results, expected before the month ends.