Lupin Gets Five U.S. FDA Observations For Its Visakhapatnam Plant
The U.S. FDA carried out inspection of Lupin’s Visakhapatnam plant between Jan. 13, 2020 and Jan. 17, 2020, the pharma firm says.
Lupin Ltd. has received five observations from the U.S. Food and Drug Administration after inspection of its Visakhapatnam plant in Andhra Pradesh.
The inspection of the company's Visakhapatnam API manufacturing facility by the U.S. FDA has been completed, Lupin said in a filing to the BSE on Saturday. The inspection was carried out between Jan. 13, 2020, and Jan. 17, 2020, it added. The inspection for the API facility at Visakhapatnam closed with five 483 observations, Lupin said.
"We are fully committed to adherence to CGMP regulations and uphold high-quality standards across all our manufacturing sites. We are confident of addressing the observations to the U.S. FDA's satisfaction," Nilesh Gupta, managing director at Lupin, said in the regulatory filing.
On Friday, Lupin shares rose1.64 percent to Rs 766.35 apiece on the NSE while the benchmark Nifty 50 shed 0.03 percent to end the day at 12,352.35 points.