The United States Food and Drug Administration (USFDA) retains the Official Action Indicated (OAI) status for Goa Plant - I (Finished Dosages Facility) of Indoco Remedies Limited. The facility was inspected by the USFDA in January 2019.
"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 Ms. Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited.
The plant currently supplies against one approved ANDA and has four ANDAs pending for approval.