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USFDA completes inspection of Lupin Bioresearch Centre Pune


USFDA completes inspection of Lupin Bioresearch Centre Pune

The inspection of Lupin Bioresearch Centre by the United States Food and Drug Administration (USFDA) has been successfully completed without any observations.

New Delhi: Drug firm Lupin Wednesday said inspection by the US health regulator of its bioresearch centre in Pune has been completed without any observations.

“This is the fifth successive inspection without any 483 observations, indicating superior quality compliance maintained at this global bioresearch facility,” the company said in a statement.

Commenting on the development, the company’s MD Nilesh Gupta said: “Such a high level of compliance reiterates Lupin’s commitment to high-quality standards across its world-class research centres.”

The centre conducts the in-vivo and in-vitro bioequivalence studies in Pune. This inspection also included review of studies done at its new site at Lupin Research Park, Pune, the statement said.

Also Read: Lupin gets EIR from USFDA for Pithampur unit

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Source: PTI
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