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USFDA Finds Regulatory Gaps in Cipla’s Pithampur Facility Inspection: Shares Tumble

Cipla’s Pithampur Manufacturing Facility has received a cGMP inspection by the USFDA.

Cipla’s Pithampur Manufacturing Facility has received a current Good Manufacturing Practices (cGMP) inspection by the USFDA (the United States Food and Drug Administration) from 6 February – 17 February 2023.

Post inspection, the company received 8 inspectional observations in Form 483.

On 4 August, the company received a communication from the USFDA stating that the facility’s inspection classification is OAI (Official Action Indicated) as the company failed to meet the regulatory requirements and may be subjected to further regulatory action.

The company posted a 45.1% growth in consolidated net profit to Rs 995.7 crore for the first quarter of the current fiscal year.

The company reported a 17.7% increase in Operating revenue from Rs 5,375.20 crore in the Q1 of the previous fiscal year to Rs 6,328.9 crore in the June quarter of the current fiscal year.

The OAI status received may cause delay or withhold of any pending product approval.

On 4 August 2023, the shares touched a 52-week high after the US-based private equity fund, Blackstone, was said to acquire a 33.47% promoter stake in Cipla by submitting a non-binding bid.

At 12:20 pm, the shares of Cipla Ltd were trading at Rs 1,206.65 or 0.26% below its previous close of Rs 1,209.75 on NSE.

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