As per the USFDA, observations have been made after inspection of a facility in response to Form 483. An FDA Form 483 notifies the company's management of objectionable conditions.
The plant currently supplies against one approved ANDA and has four more pending for approval, the company added.
New Delhi-Drug firm Indoco Remedies Wednesday said the US health regulator has retained Official Action Indicated (OAI) status for its Goa plant and may impact the approval of pending applications from this facility.
"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 Ltd. the company said in a BSE filing.
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 abbreviated new drug applications (ANDAs) from this facility," Indoco Remedies Managing Director Aditi KarePanandikar said.
The plant currently supplies against one approved ANDA and has four more pending for approval, the company added.
New Delhi-Drug firm Indoco Remedies Wednesday said the US health regulator has retained Official Action Indicated (OAI) status for its Goa plant and may impact the approval of pending applications from this facility.
"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 Ltd. the company said in a BSE filing.
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 abbreviated new drug applications (ANDAs) from this facility," Indoco Remedies Managing Director Aditi KarePanandikar said.
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