GlaxoSmithKline Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 22 October 2019.

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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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Glaxosmithkline Pharmaceuticals has been contacted by regulatory authorities regarding the detection of genotoxic nitrosamine NOMA 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 VQuality of Medicines that its certificate of suitability for ranitidine hydrochloride has beensuspended. The Company manufactures Ranitidine Hydrochloride IP Tablets 150 mg and300 mg (Zinetac) using API from Saraca Laboratories and another supplier, SMSLifesciences India, for supply to Indian market.

Based on the information provided above and as a precautionary action, the Company hasmade the decision to initiate a voluntary recall (pharmacy/retaillevel recall) of Zinetac Tablets150 mg and 300 mg products manufactured in India using API sourced from SaracaLaboratories. The product manufactured using API from SMS Lifesciences Indiawill not be recalled at this point of time. However, all such products will remain on holdand 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 NOMA. Theseinvestigations include continued engagement with our API suppliers. Patient safety remainsthe Company's utmost priority and we are taking this issue very seriously.

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Glaxosmithkline Pharmaceuticals has divested its lands at Thane admeasuring approximately 2,40,140 square meters in favour of Oberoi Realty for a total consideration of Rs. 889.50 crore. A small portion, bearing survey Nos. 182/2 & 182/3 admeasuring approximately 1,410 square meters, is excluded from this sale owing to a stay order passed by the Hon'ble Bombay High Court on 12 October 2017.

The Company has paid a sum of Rs. 337.46 crores towards obtaining all required statutory and regulatory approvals.

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