USFDA continues to classify Cipla's Goa facility as Official Action Indicated

Cipla Limited informed that the company has received a communication from the USFDA that the classification of the company’s said facility continues to be as Official Action Indicated (OAI).

This is in furtherance of its intimation dated August 26, 2022, for the United States Food and Drug Administration (USFDA) inspection of its Goa manufacturing facility.

For new product approvals, the company has an ongoing de-risking plan in place. The company will collaborate closely with the USFDA and is committed to addressing these issues within the timeframe specified, said the company in an exchange filing on Thursday.

Until the outstanding observations are cleared up, the USFDA may continue to withhold product approvals from Cipla’s Goa facility.

At around 11.46 AM, Cipla was trading at Rs1,107.40 per piece, up by 0.02% from its previous closing of Rs1,107.20 on the BSE. The scrip opened at Rs1,109.05 and touched intraday high and low of Rs1,117.15 and Rs1,103.95 respectively.

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