MUMBAI, July 31 India's Strides Arcolab
has submitted its response to observations made in
June by the U.S. Food and Drug Administration about its drug
factories, the company's chief executive said.
Shares in Strides Arcolab fell as much as 17.1 percent on
Wednesday on market talk that the U.S. FDA observations in a
so-called form-483 might affect its sales in the United States.
"We have submitted our response and we are confident about
resolving it," Arun Kumar, group chief executive officer, told
Reuters over the phone. "We continue to supply to the U.S."
A form-483 points out concerns related to manufacturing
practices. Failure to submit a satisfactory response can result
in a ban on exports to the United States from a specific
The stock was down 12 percent at 596 rupees at 0934 GMT when
the benchmark Mumbai market was up 0.05 percent.