Lupin plant gets 10 observations from US regulator; shares under pressure

Drugmaker Lupin shares were under pressure on the exchanges during Friday’s session after the USFDA issued a Form-483 with ten observations after inspecting the pharma company’s Pithampur Unit-2 manufacturing facility.

The stock of Lupin, which has been the top loser in the pharma pack, tumbled to as low as 4 per cent to hit the day’s low of Rs 628.10 per share. It quoted Rs 641.10 a share at around 12:05 PM, down Rs 11.35 or 1.74 per cent compared to Wednesday’s close of Rs 652.45 apiece.

The share market on Thursday, March 30, 2023, was shut on account of Ram Navami – which is celebrated as the birth anniversary of Lord Ram.

On the contrary, the Nifty Pharma index at the same time was up 0.7 per cent and the Nifty50 index grew more than 1 per cent today.

The US Food and Drug Administration (USFDA) inspected the plant from March 21 to March 29, 2023, and ended the inspection by issuing a Form-483 with ten observations, Lupin said in a filing.

Lupin’s statement on USFDA observation

The pharma company in its statement said, “We are addressing the observations comprehensively and will work with the US FDA to resolve these issues at the earliest”.

Lupin shares price history

Pharma stock has declined nearly 14 per cent in the last year as compared to a per cent fall in the Nifty50 index.

While the shares of Lupin were down over five per cent against one per cent gain in the benchmark index.

Brokerage maintains Hold

Param Desai, a research analyst at Phillip Capital believes that the margins of Lupin will improve only with likely savings and niche launches.

Besides, recovery in US sales will be gradual and may hinge on timely niche launches, Desai said, maintaining a ‘hold’ rating with a target of Rs 675 per share.

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