Lupin shares fall as US facility gets six USFDA observations

Shares of pharma firm Lupin are in news today after US Food and Drug Administration (FDA) conducted a pre-approval inspection of its manufacturing facility in Somerset, New Jersey.  The company said the inspection concluded with the issuance of a Form-483, containing six observations. The inspection was held from May 7 to May 17, 2024, it added.

In a statement to BSE, Lupin disclosed, "We would like to inform you that the US FDA concluded a pre-approval inspection at Lupin’s Somerset, New Jersey, manufacturing facility. The inspection was conducted from May 7, 2024, to May 17, 2024, and closed with an issuance of a Form-483 with six observations."

The issuance of a form-483 indicates observations made by FDA inspectors concerning potential violations of regulatory significance. US FDA investigators would have observed conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Lupin said the company was addressing the observations comprehensively and will respond to the US FDA within the stipulated timeframe.

This disclosure is made in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, said Lupin in a communication to BSE.

On Monday, Lupin shares ended at Rs 1659.95. In the current session, the Lupin stock slipped 2.33% in early deals to Rs 1621 on BSE. Market cap of the firm fell to Rs 74,061 crore. Total 1282 shares of the firm changed hands amounting to a turnover of Rs 20.92 lakh on BSE.    

Earlier, the stock opened lower at Rs 1656.80 on BSE. Stock of Lupin has gained 111.38 per cent in a year and risen 24.65 per cent in 2024.

The share hit a 52-week high of Rs 1703.80 on March 11, 2024 and a 52-week low of Rs 766.05 on May 24, 2023.  

The stock has a beta of 0.3, indicating very low volatility in a year. 

In terms of technicals, the relative strength index (RSI) of Lupin stock stands at 55.3, signaling it's trading neither in the overbought nor in the oversold zone. Lupin shares are trading lower than the 5 day, 10 day but higher than the 20 day, 50 day, 100 day , 150 day and 200 day moving averages.  

Lupin is a pharmaceutical company producing, developing and marketing a wide range of branded nd generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.