Hot Pursuit     15-Jun-23
FDC two facilities in Maharashtra concludes USFDA inspection with zero observations
FDC said that US Food and Drug Administration (USFDA) has successfully completed its inspection at Aurgangabad and Roha facility with classification of no action needed (NAI).
The drug regulator inspected the company's manufacturing facility located at Aurangaband, Maharashtra from 6 Februrary 2023 to 12 February 2023. Based on the inspection, the said facility is considered to be in an acceptable state of compliance with regards to current good manufacturing practice (CGMP).

USFDA has concluded that the inspection is closed and copy of the narrative portion of the Establishment Inspection Report (EIR) has been issued.

Meanwhile, the company's manufacturing facility located at Rohas, Raigad District, Maharashtra has also received classification of NAI from USFDA. The USFDA had conducted inspection from 20 March to 24 March 2023.

Based on the inspection, the facility is considered to be in an acceptable state of compliance with regards to current good manufacturing practice (CGMP). The USFDA has concluded that this inspection is closed and a copy of the narrative portion of the Establishment Inspection Report (EIR) has been issued.

FDC is a fully integrated research-oriented pharmaceutical company engaged in the manufacturing and marketing of Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs).

The company's consolidated net profit jumped 194.2% to Rs 30.71 crore in Q4 FY23 as compared with Rs 10.44 crore in Q4 FY22. Net sales increased 27.5% year on year to Rs 434.80 crore in Q4 FY23.

The scrip was declined 0.24% to Rs 308.05 on the BSE.

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