Lupin gains as USFDA completes inspection at Gujarat facility with zero observation

Shares of Lupin Ltd gained more than 2% on Friday, April 12, after the company announced completion of inspection by the United States Food and Drug Administration (USFDA) at its manufacturing facility in Vadodara, Gujarat, with no observations.

The inspections at Lupin’s API manufacturing facility in Dabhasa, Vadodara, were held from April 8 to April 12, 2024, the pharma major informed the stock exchanges in a filing.

The US drug regulator completed the inspection with no observations, the company said.

After the announcement, Lupin shares gained as much as 2.32% to hit an intraday high of ₹1,641.95 apiece on the NSE. However, the stock pared some of its gains to close at ₹1,624 apiece, up 1.21%.

Lupin Managing Director, Nilesh Gupta, said, “We are pleased to announce the successful completion of the USFDA inspection of our Dabhasa facility. This accomplishment underscores our unwavering dedication to maintaining the highest standards of quality and compliance in all aspects of our operations. This reaffirms our pursuit of excellence in delivering high-quality, affordable healthcare for all.”

Earlier this month, Lupin announced in another exchange filing that it launched the first generic version of Oracea (Doxycycline Capsules, 40 mg) in the United States, following approval from the USFDA. The drug has been developed for treating inflammatory lesions like papules and pustules associated with rosacea, which is a kind of skin infection, in adults.

Mumbai-based Lupin Ltd specialises in developing and marketing a range of branded and generic formulations, biotechnology products and APIs. The company operates in more than 100 markets globally, including the U.S., India, South Africa and regions across Asia Pacific, Latin America, Europe and the Middle East.