Lupin Shares Decline After USFDA Issues Six Observations for Nagpur Plant

17 Sep 2025 , 11:05 AM

Shares of Lupin Ltd dipped 0.81% on Wednesday, September 17, at 11:02 am, after the company said the US Food and Drug Administration (USFDA) issued six observations for its Nagpur injectable facility. The inspection was held between September 8 and 16. Lupin did not disclose the details of the observations but said it would respond within the required timeline.

“We will address the observations and respond to the USFDA within the stipulated timeframe. We remain committed to cGMP standards across all our facilities,” the company said in a filing.

The update comes just weeks after Lupin secured USFDA approval for its Risperidone Injectable, used to treat schizophrenia and bipolar disorder. The drug, available in 25 mg, 37.5 mg, and 50 mg vials, is the bioequivalent of Risperdal Consta Long-Acting Injection.

Lupin shares had rallied for eight straight sessions until Tuesday, a streak last seen in late December 2024. in the last year, lupin shares have dipped 10%, 14% in the year-to-date, gained 3.21% in the last months, and up 1.97% in the last 5 days.

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