Lupin gets 5 observations from USFDA

Drug firm Lupin said it has received five observations from the US health regulator after inspection of its Vizag facility in Andhra Pradesh.

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Lupin gets 5 observations from USFDA

Drug firm Lupin said it has received five observations from the US health regulator after inspection of its Vizag facility in Andhra Pradesh.

The inspection of company’s Vizag API manufacturing facility by the United States Food and Drug Administration (USFDA) has been completed, Lupin said in a filing to BSE.

The inspection was carried out between January 13, 2020 and January 17, 2020, it added.

Also read: Strides gets USFDA nod for anti-allergic drug

The inspection for the API facility at Vizag closed with five 483 observations, Lupin said.

“We are fully committed to adherence with CGMP regulations and uphold high quality standards across all our manufacturing sites.

We are confident of addressing the observations to the US FDA’s satisfaction,” Lupin MD Nilesh Gupta said.

Also read: USFDA approves Cocaine HCl nasal solution 4%

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