Cipla shares dip as USFDA finds regulatory gaps in Pithampur facility inspection

We do not see material risk to our existing commercial product portfolio and the company is in the process of executing derisking plan for its new products, said Cipla.

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Cipla shares were trading lower in the early trade on August 7 after USFDA said that the inspection has not met regulatory requirements.

The United States Food and Drug Administration (USFDA) had conducted a current Good Manufacturing Practices (cGMP) inspection at the company’s Pithampur manufacturing facility between February 6-17, 2023.

On the conclusion of the inspection, the company had received 8 inspectional observations in Form 483.

On August 4, the company received a communication from USFDA stating the inspection classification of the said facility is official action indicated (OAI) as the company has not met regulatory requirements and may be subject to further regulatory action.

The OAI status may cause delay/withholding of pending product approvals.

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We do not see material risk to our existing commercial product portfolio and the company is in the process of executing a derisking plan for its new products, said Cipla.

US-based private equity fund, Blackstone is said to be submitting a non-binding bid to acquire the entire 33.47 percent promoter stake in Cipla, The Economic Times reported last week.

The company had posted a 45.1 percent growth in consolidated net profit to Rs 995.7 crore for the April-June quarter, as against Rs 686.38 crore clocked in the same period a year ago.

It has reported a 17.7 percent increase in consolidated revenue to Rs 6,328.9 crore in comparison to Rs 5,375.20 crore, YoY.

At 09:32 hrs Cipla was quoting at Rs 1,201.70, down Rs 7.85, or 0.65 percent.

The share touched a 52-week high of Rs 1,238.55 and a 52-week low of Rs 852.00 on August 4, 2023, and March 22, 2023, respectively.

Currently, the stock is trading 2.98 percent below its 52-week high and 41.04 percent above its 52-week low.