Strides Pharma drops 3% on USFDA observation for Bengaluru plant
The observations are not material in nature, the company said.
By ETMarkets.com |
BCCL
NEW DELHI: Shares of Strides Pharma Science declined 3 per cent in Wednesday’s trade after the drug maker post Tuesday's market hours said the USFDA has issued three observations to its formulations facility in Bangalore.
"The formulations facility in Bangalore recently underwent pre-approval product inspection by the USFDA. The inspection ended on August 25 and the company has been issued a Form 483 with 3 observations," Strides Pharma Science said in a regulatory filing.
The stock fell 2.56 per cent to hit a low of Rs 486.30 on BSE.
The observations are not material in nature, the company said.
As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The company has already responded to the USFDA, it Strides Pharma Science said.
"The formulations facility in Bangalore recently underwent pre-approval product inspection by the USFDA. The inspection ended on August 25 and the company has been issued a Form 483 with 3 observations," Strides Pharma Science said in a regulatory filing.
The stock fell 2.56 per cent to hit a low of Rs 486.30 on BSE.
The observations are not material in nature, the company said.
As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The company has already responded to the USFDA, it Strides Pharma Science said.
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