Lupin shares decline after USFDA issues six observations for Nagpur facility

Shares of Lupin Ltd. declined on Wednesday, September 17, after the company on Tuesday said the US drug regulator has issued six observations for the company's Nagpur injectable facility.

Lupin said the US Food and Drug Administration (USFDA) conducted an inspection at the facility between September 8 to September 16. The company though, has not specified the nature of the observations.

"We will address the observations and respond to the USFDA within the stipulated timeframe. We are committed to be compliant with current good manufacturing practices (CGMP) quality standards across all our facilities," Lupin said in an exchange filing.

Earlier this month

, the USFDA gave its approval for Lupin's abbreviated new drug application (ANDA) for Risperidone Injectable, which is used to treat Schizophrenia & bipolar disorder.

The injectable is the bioequivalent to the reference-listed drug Risperdal Consta Long-Acting Injection.

Lupin said it received the USFDA's nod for the Risperidone for extended-release injectable suspension, in the 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, single-dose vials.

Lupin shares have gained for eight consecutive trading sessions as of Tuesday's close. The last time the stock gained for eight consecutive sessions was between December 23, 2024 to January 1, 2025.

Lupin shares were down 1.1% at ₹2,029.5 apiece around 9.20 am on Wednesday.