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Dr Reddy's Shares Crash On Fresh US FDA Worries
Shares in Dr Reddy's crashed after the US FDA identified significant deviations at the plants of the company it had inspected.
Earlier this month the company was issued a warning letter from the US FDA for these three plants. The stock crashed almost 7 per cent, following new details uploaded by the US FDA. The shares were last trading at Rs 3170, on the National Stock Exchange.
"These deviations and violations cause your APIs and finished drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 351(a)(2)(B). The methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP," the US FDA has said in its warning letter.
"Several violations are recurrent or represent long-standing failures to adequately resolve significant manufacturing quality problems. It is apparent that you have not implemented a robust quality system at your sites," the US FDA has said.
"Until you complete all corrections and FDA confirms your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product or API manufacturer."
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