Shares of Lupin Ltd were trading in the red and 2% lower on 7 October after the company announced receiving 5 observations from the USFDA. 

In its regulatory filing, the company said that the US Food and Drug Administration (USFDA) had conducted a pre-approval inspection at the company’s biotech facility in Pune, Maharashtra between 25 September and 4 October. 

The US health regulator concluded the inspection and issued five observations for the said facility. 

The company, in its filing, added, “The Company is addressing the observations comprehensively and will respond to the US FDA within the stipulated time frame.”

Earlier in September, the company had received three observations for its Pithampur Unit-1 API and finished product manufacturing facility.

In order to provide Vonoprazan tablets, a cutting-edge gastrointestinal medication, to the Indian market, the company has engaged into a non-exclusive patent licensing deal with Takeda.

At 11:39 am, the shares of Lupin were trading 1.18% lower at Rs 2,172.30 on NSE, 

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