Cadila Healthcare gets EIR from US FDA for Changodar facility

Last month, the firm received EIR for its manufacturing facility in Moraiya

Drug firm Cadila Healthcare on Tuesday said it has received Establishment Inspection Report (EIR) for its Changodar manufacturing plant located near Ahmedabad from the US health regulator after successful completion of inspection.

"The company's topical manufacturing facility located at Changodar, Ahmedabad, has received an EIR from the US FDA (US Food and Drug Administration) following the inspection carried out in March 2016," Cadila said in a BSE filing.

It further said: "The receipt of EIR indicates the successful closure of the inspection points (483s) raised. The topical plant is a dedicated facility for manufacturing ointments and does not form a part of the Moraiya formulations manufacturing plant."

 

EIR is given to an establishment after the completion of the inspection by the FDA.

Last month, Cadila Healthcare had received EIR from the US health regulator for its manufacturing facility in Moraiya, indicating "closure of the inspection points" of initial review in 2014.

Cadila Healthcare shares were trading 1.23 per cent down at Rs 364.60 on BSE.