Home / Markets / Stock Markets /  Strides Pharma shares hit 52-week low, down over 8% on Ranitidine suspension

New Delhi: Shares of Strides Pharma tumbled over 8% on Tuesday after the company informed about suspension of Ranitidine Tablets in the US markets.

At 12:55 pm, the company was trading at 8.08% lower at 302.05 on BSE. On NSE, the stock was at 8.09%. The company touched its 52-week low of 301.65 today. It had its 52-week high on 22 January 2019 at 550.40.

"As advised in our earlier notification to the Stock Exchanges on September 25, 2019, Strides has received an Information Request (IR) from the USFDA to provide test data related to Nnitrosodimethylamine (NDMA) impurities in Ranitidine tablets. This data is to be provided to the agency in 30 days," Strides said in a regulatory filing on Friday.

While the company will conduct the relevant tests mandated by the US Food and Drug Administration (FDA), it has suspended sales of ranitidine tablets in the US market until it has clarity of next steps as would be indicated by the USFDA.

Also read: Opinion | Pill popper alert

The company predominantly sells Ranitidine tablets in the US markets, and its front end sales globally for the product were ~US$ 9 million in H1FY20. In spite of this temporary suspension of the ranitidine supplies, the Company retains its FY20 growth outlook for the US markets.

Meanwhile, India’s apex drug regulator has asked its state-level counterparts to get manufacturers to test anti-acidity drug ranitidine for the impurity N-nitrosodimethylamine. The directive by the Central Drugs Standard Control Organisation came just days after the USFDA flagged low-level presence of carcinogenic substance in ranitidine.

“It has been reported from other countries that some ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine at low levels. The N-nitrosodimethylamine (NDMA) has been classified by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans," Drug Controller General (India) V.G. Somani said in the letter, a copy of which was accessed by Mint.

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