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Pharmaceutical major Dr. Reddy’s Laboratories Ltd witnessed a highly volatile day as the company’s stock tumbled as much as 29.78 per cent during the Friday trading session, reaching its 17 year low. The stock, however, recovered much of its loss and closed with a 4.17 per cent drop.
The shares of Dr. Reddy’s Laboratories Ltd. tumbled major;y after the U.S. drug regulator reiterated issues regarding manufacturing standards at its plant in Bachupally, Telangana that supplies to the American market. The facility under observation was inspected between January 30 and February 8 and currently accounts for 40-45 per cent of Dr. Reddy’s sales in the USA.
According to the Form 483 issued by the U.S. Food and Drug Administration (USFDA), the drugmaker received 11 observations on issues ranging from manufacturing procedures to quality control. Four of these observations were also flagged in a 2017 inspection and one in 2015.
Some of the observation issued by US FDA stated, “Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. The quality control unit lacks the responsibility and authority to reject all drug products. Master production and control records lack sampling and testing procedures.”
