Lupin Shares Gain on ‘No Observation’ Certificate from USFDA Inspection

The USFDA completed its inspection of Lupine's biological research center in Pune without observation.

Lupin shares rose in early trading on March 14 after receiving a “no observation” certificate from the US Food and Drug Administration (USFDA).

At 9:16 am, Lupin was trading at Rs 663.50, up Rs 9.15, or 1.4%.

Lupin announced that the USFDA had completed an inspection of its bioresearch centre in Pune, India. In its press release, the company said the Lupin Bioresearch Centre conducts BA/BE, PK/PD, in vitro BE and biosimilar studies and closes inspections without any observations.

From March 6 to March 10, the USFDA conducted pre-approval and GMP inspections of its API manufacturing facility in Visakhapatnam and found no observations.

Shares of the pharma company hit a 52-week high of Rs 798.90 and a 52-week low of Rs 583.05 on April 5, 2022, and May 25, 2022, respectively. It is trading 16.95% below its 52-week high and 13.8% above its 52-week low. Shares were down 12% over the past three months. The Nifty Pharmaceuticals index is down 18% this year and more than 12% over the past year.

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