After conducting an inspection in January, USFDA has retained the Official Action Indicated (OAI) status for the drug firm’s Goa Plant
Drug firm Indoco Remedies on Wednesday said the US health regulator has retained Official Action Indicated (OAI) status for its Goa plant and may impact approval of pending applications from this facility.
“The United States Food and Drug Administration (USFDA) has retained the Official Action Indicated (OAI) status for Indoco Remedies’ Goa Plant-I (finished dosages facility). The facility was inspected by the USFDA in January 2019,” the company said in a BSE filing.
“We are in the process of sending our responses to the Regulators, as and when the commitments given in response to Form 483 observations are fulfilled. We believe that this OAI status will not impact our current commercial supplies to USA or revenues from this manufacturing facility. However, this may withhold approval of our pending ANDAs from this facility”, said Aditi Kare Panandikar, Managing Director, Indoco Remedies
The plant currently supplies against one approved ANDA and has four ANDAs pending for approval.