Indoco gets another setback from US FDA, retains OAI status of Goa Plant I

Our Bureau, Mumbai

Wednesday, April 24, 2019, 15:40 Hrs [IST]

The United States Food and Drug Administration (FDA) retains the Official Action Indicated (OAI) status for Goa Plant – I (finished dosages facility) of Indoco Remedies Limited. The facility was inspected by the US FDA 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 Aditi Kare Panandikar, managing director, Indoco Remedies Limited.

The plant currently supplies against one approved ANDA and has four ANDAs pending for approval.

Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma Company with presence in 55 countries. Indoco, a USD 161 million Company, employs over 5500 people including more than 300 skilled scientists.