GSK Pharma slides on halting supply of acidity drug Zinetac

Glaxosmithkline Pharmaceuticals fell 2.76% to 1395.90 after the company suspended the release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India.

Ranitidine, sold under the trade name Zantac among others, is a medication which decreases stomach acid production. The US drug regulator reportedly found a cancer-causing impurity called N-nitrosodimethylanine (NDMA) in some products containing Ranitidine.

Glaxosmithkline Pharmaceuticals (GSK Pharma) said it was been contacted by regulatory authorities regarding the detection of genotoxic nitrosamine NDMA in Ranitidine products. Based on the information received and correspondence with regulatory authorities, GSK made the decision 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.

Subsequently, Saraca Laboratories were notified by the European Directorate for V Quality of Medicines that its certificate of suitability for ranitidine hydrochloride has been suspended. The company manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) using API from Saraca Laboratories and another supplier, SMS Lifesciences India, for supply to Indian market.

Based on the information provided above and as a precautionary action, the company has made the decision to initiate a voluntary recall (pharmacy/retail level recall) of Zinetac Tablets 150 mg and 300 mg products manufactured in India using API sourced from Saraca Laboratories. The product manufactured using API from SMS Lifesciences India will not be recalled at this point of time. However, all such products will remain on hold and they will not be released to the market while the company will await the test results. GSK is continuing with investigations into the potential source of the NDMA. These investigations include continued engagement with the firm's API suppliers.

The S&P BSE Sensex was up 347.40 points or 0.90% to 38,940.92. The S&P BSE Healthcare rose 84.98 points or 0.66% to 12,893.16, underperforming the Sensex.

On the BSE, 2360 shares were traded in the counter so far compared with average daily volumes of 7574 shares in the past two weeks. The stock hit a high of Rs 1416 and a low of Rs 1385 so far during the day.

The stock hit a 52-week high of Rs 1544.95 on 02 Jan 2019. The stock hit a 52-week low of Rs 1131.05 on 12 Jul 2019.

On a consolidated basis, GSK Pharma's net profit rose 27.2% to Rs 113.54 crore on a 7.1% increase in net sales to Rs 787.97 crore in Q1 June 2019 over Q1 June 2018.

GlaxoSmithKline Pharmaceuticals is a one of the world's leading research-based pharmaceutical and healthcare companies.

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