Lupin shares fall as USFDA concludes inspection at Aurangabad facility with one observation

Shares of pharma giant Lupin Ltd marginally dropped after the company announced that its Aurangabad manufacturing facility received one observation during an inspection by the United States Food and Drug Administration (USFDA).

On the USFDA observation, the Mumbai-headquartered drug firm said that it is confident of addressing the concern raised by the US regulatory body and will resolve the matter at the earliest.

In an exchange filing on Friday, the global pharma major informed that the USFDA inspected its manufacturing facility at Aurangabad, Maharashtra, from March 6 to March 15, 2024. The inspection closed with the issuance of a Form-483 with one observation.

The US drug regulator issues a Form-483 when it observes any lapses during its inspection of a drug manufacturing facility.

Lupin Ltd reiterated that it upholds quality and compliance with utmost importance and is "committed to comply with CGMP quality standards" across all facilities.

After the announcement, shares of Lupin Ltd dropped as much as 1.8% to hit a day's low of ₹1,607.5 apiece on NSE. However, the pharma stock recovered some losses to trade at ₹1,614.50 apiece, down 1.36% at 13:01 pm.

Meanwhile, in a separate filing on Monday, the pharma major announced the appointment of Christoph Funke as Chief Technical Operations Officer, with immediate effect. His appointment is not for a fixed term, as per the filing.

Funke has over 30 years of global pharmaceutical manufacturing and technical operations experience and expertise, the filing said. Funke served as the Chief Operations Officer of Strides Pharma Science in Bangalore, India, since 2021, in his last assignment.

In its Q3FY24 results, Lupin Ltd posted a massive 300% rise in its consolidated net profit at ₹613 crore, compared to ₹153.4 crore registered in the year-ago period. This surge was on the back of record sales and strong growth by the company across geographies.