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Strides Pharma stock hits fresh 52-week low after suspending sale of Ranitidine Tablets in US

BusinessToday.In     September 27, 2019

Strides Pharma stock fell 6% to hit a new-52 week low of Rs 305 on Friday's trading session after the Pharmaceutical firm announced the suspension of sales of Ranitidine tablets in the US market.

Reacting to the latest developments, the share price of Strides Pharma fell 7.1% to the day's low of Rs 308.60, against the last closing price of Rs 328.60, also its fresh 52-week low. The scrip opened at Rs 332 and touched a high and low of Rs 332 and Rs 305, respectively.

The stock has fallen 13.56% in the last 5 trading sessions and trades lower than 5, 20, 50, 100 and 200-day moving averages. The stock has been highly volatile today with an intraday volatility of 5.05%.

Overall, 1.75 lakh and 20.20 lakh share sare changing hands on BSE and NSE, both above 5,10, and 30-day average volume traded.

Strides Pharma Science announced that while the company conducts the relevant tests mandated by the USFDA, it has suspended sales of ranitidine tablets in the US market until such time it has clarity of next steps as would be indicated by the USFDA. Ranitidine tablets were amongst the top 5 products sold by the company in the USA, as per the company's earlier filing.

Strides has approval for Rx and OTC Ranitidine tablets for the US market and are only commercializing the Rx product currently, the company said in the filing.    

The USFDA has learned that some Ranitidine products contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. The impurity Nnitrosodimethylamine(NDMA) is toxic to the liver and other organs and is a probable human carcinogen. It is also used to create cancer in rats for cancer research.

NDMA is classified as an extremely hazardous substance in the United States as defined in Section 302 of the U.S. Emergency Planning and Community Right-to-Know Act (42 U.S.C. 11002) and is subject to strict reporting requirements by facilities that produce, store, or use it in significant quantities.

The regulatory statement added," Strides Pharma 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."

In another development, Strides Pharma Science Limited's step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Solifenacin Succinate Tablets, 5 mg and 10 mg from the United States Food & Drug Administration (USFDA).  The product is a generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc.

As of 1200 IST, the share price of Strides Pharma Science was trading 6.09% or 20 points lower at Rs 308.60 on the BSE.

By Rupa Burman Roy

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