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Cipla share price loses over 7% on fears of USFDA action against Goa unit

Cipla share price has lost 2.51% in last 2 days. The US drug regulator carried out inspection from September 16-September 27 in the Goa unit of the firm.  It has subsequently issued form 483 comprising 38 pages which carries 12 observations for the Cipla's Goa facility.

twitter-logo BusinessToday.In        Last Updated: October 11, 2019  | 10:53 IST
Cipla share price falls over 2% after USFDA issues form 483 for Goa unit
Cipla share price fell up to 2.38% to Rs 412.2 compared to the previous close of Rs 422.25 on BSE.

Cipla share price fell in early trade today after USFDA issued form 483 for the Goa manufacturing facility of the firm. Cipla share price fell up to 7.74% to Rs 389.55 compared to the previous close of Rs 422.25 on BSE.

The pharma stock has lost 2.51% in last 2 days. The US drug regulator carried out inspection from September 16-September 27 in the Goa unit of the firm.  It has subsequently issued form 483 comprising 38 pages which carries 12 observations for the Cipla's Goa facility.

The observations assume significance since the firm's Goa unit generates 25 to 30% of US business.

The observations say facility will require very extensive change in standard operating procedures, and processes which could require a bit longer for the company to resolve issues.

A note by brokerage Equirus said there is strong likelihood for Official Action Indicated (OAI) classification and thus a warning letter for the firm post the inspection.

According to FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections. OAI means an FDA inspection revealed significant objectionable conditions or practices and action must be taken to address the issues.

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