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Strides Arcolab has submitted its response to observations made in June by the US Food and Drug Administration about its drug factories, the company's chief executive said.
Shares in Strides Arcolab fell as much as 17.1% on Wednesday on market talk that the US 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 US"
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 manufacturing facility.
The stock was down 12% at 596 rupees at 0934 GMT when the benchmark BSE Sensex <.BSESN> was up 0.05%.
