Lupin share price gains on ‘no observation’ certificate from USFDA inspection

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.

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Lupin shares gained in the early trade on March 14 after the company received a ‘no observation’ certificate from US Food and Drug Administration.

At 9:16am, Lupin traded at Rs 663.50, up Rs 9.15, or 1.40 percent.

Lupin announced that the USFDA has completed an inspection of its Bioresearch Centre in Pune, India.

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies and inspection closed without any observation, company said in its release.

“We are pleased to announce that the Lupin Bioresearch Centre has successfully undergone its seventh consecutive onsite inspection, reaffirming our commitment to patient safety and our superior quality and compliance standards,” said Managing Director Nilesh Gupta.

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The USFDA carried out a pre-approval and GMP inspection of its API manufacturing facility in Visakhapatnam from March 6 to March 10 and concluded with no observations.

The share price touched a 52-week high Rs 798.90 and 52-week low Rs 583.05 on April 5, 2022 and May 25, 2022, respectively. It is trading 16.95 percent below its 52-week high and 13.8 percent above its 52-week low. In the last three months, the share price has declined by 12 percent.

The Nifty pharma index shed 18 percent tear to date, while in last one-year it fell more than 12 percent.