By CNBC-TV18 Jul 17, 2019 1:18:14 PM IST (Published)
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Strides Pharma Science’s shares plunged 8.2 percent intraday on Wednesday after the company received a warning letter from the United States Food and Drug Administration (US FDA) citing data integrity issues.
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At 11:50 am, the share was trading at Rs 370.35 per share, down 1.98 percent on the NSE. Intraday, the stock plunged over 8 percent to its day’s low at Rs 347.10.
The US FDA pointed to a quality system that does not ensure the accuracy and integrity of data. Besides the data integrity issues, the warning letter also points out issues in test results that did not meet criteria. The USFDA said the responses by Strides to the observations were inadequate.
The warning letter was issued on July 1. The company’s Puducherry facility currently manufactures 6 drugs which won’t get impacted due to the warning letter. However, the 10 drugs filed for approval from the plant will get delayed till the site is remediated, which is almost 30 percent of the company’s total drug pipeline.
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