Dr Reddy’s Labs tanks 3% as Duvvada facility receives 13 USFDA observations
NEW DELHI: Shares of Dr Reddy’s Labs dropped over 3 per cent to hit a 52-week low in Thursday’s trade after the drugmaker informed NSE that the US Food and Drug Administration (FDA) has made 13 observations relating to deviation from good manufacturing practices (GMP) at the company’s cancer formulations facility at Duvvada in Visakhapatnam.
Following the development, the stock fell 3.52 per cent to hit a 52-week low of Rs 2,751 on BSE.
Form 483 is issued to a firm at the conclusion of an inspection when the investigators observe any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company's management of objectionable conditions.
"The audit of our formulation manufacturing facility at Duvvada, Visakhapatnam, by the USFDA has been completed today (Wednesday). We have been issued a Form 483 with 13 observations, which we are addressing," the company told NSE.
The oncology formulations facility at Duvvada was initially inspected in February 2015 by USFDA after which it had issued warning letters raising concerns over violations of good manufacturing practices (GMP) at the unit, TOI reported. Following this, DRL had carried out extensive remediation work at its unit and had requested USFDA to reaudit the facility, it noted.
Following the development, the stock fell 3.52 per cent to hit a 52-week low of Rs 2,751 on BSE.
Form 483 is issued to a firm at the conclusion of an inspection when the investigators observe any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company's management of objectionable conditions.
"The audit of our formulation manufacturing facility at Duvvada, Visakhapatnam, by the USFDA has been completed today (Wednesday). We have been issued a Form 483 with 13 observations, which we are addressing," the company told NSE.
The oncology formulations facility at Duvvada was initially inspected in February 2015 by USFDA after which it had issued warning letters raising concerns over violations of good manufacturing practices (GMP) at the unit, TOI reported. Following this, DRL had carried out extensive remediation work at its unit and had requested USFDA to reaudit the facility, it noted.
