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Dr. Reddy's falls 6% Shares of Dr. Reddy's Laboratories fell over 6 percent on Tuesday morning as investors reacted to the company receiving observations for its Duvvada unit.
The drug maker said it got Form 483 with 8 observations from US FDA for its injectable plant in Duvvada.
"This is to inform you of our formulations manufacturing facility at Duvvada, Visakhapatnam, by the US FDA
"The company said in a statement to stock exchanges.
" We have been issued a Form 483 with 8 (eight) comments, which we are addressing, "the company added.
The company
The US drug regulator conveys its concerns about manufacturing practices through Form 483. Companies that receive observations must respond to a corrective and preventative action plan in 15 days. Company's Duvvada Unit, known as FTO-VII, Injectable Cytotoxic and Hormonal Manufactures is under public notice since November 2015,
The inspection has begun on October 22.
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Dr. Reddy's Falls 6% Shares of Dr. Reddy's Laboratories fell over 6 percent on Tuesday morning as investors reacted to the company receiving observations for its Duvvada unit.
The drug maker said it got Form 483 with 8 observations from US FDA for its injectable plant in Duvvada.
"This is to inform you of our formulations manufacturing facility at Duvvada, Visakhapatnam, by the US FDA
"The company said in a statement to stock exchanges.
" We have been issued a Form 483 with 8 (eight) comments, which we are addressing, "the company added.
The company
The US drug regulator conveys its concerns about manufacturing practices through Form 483. Companies that receive observations must respond to a corrective and preventative action plan in 15 days. FUP-VII, known as FTO-VII, is a manufacturer of cytotoxic and hormonal injectable drugs.
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