Ranbaxy has received a form 483 with certain observations from the US Food and Drugs Administration, on its Toansa bulk drug plant in Punjab, reports CNBC-TV18. Ranbaxy shares are down around 8 percent to Rs 427, and have been under pressure since morning.
Form FDA 483 is a form used by the US FDA to document and communicate concerns discovered during its inspections. The company that receives the form has to commit to addressing those concerns within a specified deadline.
Ranbaxy has said that it is assessing the observations and will respond to the USFDA at the earliest. This matter is critical for Ranbaxy since 70-75 percent of the company’s manufactured active pharmaceutical ingredients (APIs) are from there, reports CNBC-TV18.
The USFDA had issued a Form 483 to the plant in 2012.
In May last year, the Ranbaxy had to pay USD 500 million to settle fraud charges. In June, the company’s Mohali unit was served a Form 483 by the USFDA. Then in September, the USFDA barred the Mohali plant from importing drugs to the US.
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