Indoco Remedies clears USFDA inspection
US Food and Drug Administration (USFDA), has cleared the sterile manufacturing facility of Indoco Remedies Limited, for Finished Dosages, located at Verna Industrial Area, Goa (Plant II). This inspection was carried out by USFDA in November 2018.
The change in the Inspection Classification status from 'Official Action Initiated’ (OAI) to 'Voluntary Action Initiated’ for Indoco Remedies Limited, by USFDA signifies that, the site has come out of the 'Warning Letter’, issued in March 2017.
As per the company's note this is an outcome of the recent inspection conducted by the US drug regulator in Nov 2018.
There are several abbreviated new drug applications (ANDAs) pending from this facility which will now be approved, as per Indoco Remedies.
Also shares for Indoco remedies are gained by 2% after incoming of this news.