The plant located in Ankleshwar, in the Gujarat region of India makes bulk active pharmaceutical ingredients (APIs) but a US Food and Drug Administration (FDA) import alert issued on Friday means the products are now banned from being exported to the US.
In a filing to the Bombay Stock Exchange, Wockhardt acknowledged the US FDA has updated the Import Alert 66-40 to include its API unit and said it was awaiting official communication from the US FDA on this matter.
The FDA’s actions come following an inspection last year which resulted in a Form 483, highlighting a number of manufacturing concerns.
“The Company has already initiated required steps to address the concerns raised by USFDA and is putting all efforts to resolve the matter,” Wockhardt added.
The API plant is the third Wockhardt facility to be banned from sending products to the US.
The company’s Waluj and Chikalthana finished formulation plants – both in Aurangabad, Maharashtra – were hit with an import alert, with products made at the sites placed under Detention Without Physical Examination (DWPE) by the FDA, in 2013.
Shares in Wockhardt fell by nearly 14% Monday, following the FDA’s announcement.