Lupin shares fall as USFDA issues six observations for Nagpur facility

Lupin shares declined nearly 2% on Wednesday on news that the US Food and Drug Administration (USFDA) issued six observations after an inspection at its Nagpur injectable facility. Lupin said the US Food and Drug Administration (USFDA) conducted an inspection at the facility between September 8 to September 16.

In the current session, the Lupin stock fell 1.68% to Rs 2016.80 on BSE. Market cap of the firm slipped to Rs 93,079 crore. Total 6778 shares of the firm changed hands amounting to a turnover of Rs 1.37 crore on BSE.    

Earlier, the stock opened lower on BSE. 

The company has not detailed the nature of these observations, only stating, "The company though, has not specified the nature of the observations." Investors responded to the regulatory update after Lupin's eight-session winning streak, which lasted from late December 2024 to early January 2025.

"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.

The company now faces the task of addressing these regulatory observations in line with industry compliance standards. Trading activity reflected cautious sentiment, as investors weighed the implications for ongoing operations and future US approvals. The exchange update and swift response aim to reassure stakeholders during a period of heightened scrutiny.

Amid the regulatory development, Lupin also announced a recent USFDA approval for its abbreviated new drug application (ANDA) for Risperidone injectable extended-release suspension.

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.

This product is the bioequivalent to Risperdal Consta Long-Acting Injection, intended for Schizophrenia and bipolar disorder. The company’s regulatory progress and pipeline remain focal points for market analysts and investors, as the pharmaceutical sector continues to navigate stringent global compliance requirements and competitive pressures.