Lupine said the United States Food and Drug Administration had completed inspecting its bioresearch center in Pune, without making any regulatory observations.
Lupin’s bioresearch center conducts a range of bio-equivalence and biosimilar studies, the company said, adding “the inspection closed without any observation.” This was the bioresearch centre’s successful completion of its seventh consecutive onsite inspection, said Nilesh Gupta, Lupin Managing Director.
The development comes on the heels of a successful completion of certain inspections at Lupin’s Vishakapatnam facility. According to the company, the USFDA had completed a pre-approval and GMP (good manufacturing practices) inspection of its active pharmaceutical ingredients (API) manufacturing facility at Visakhapatnam (Vizag), without making any observations.
Indian drugmakers have been seeing an increase in physical regulatory inspections as travel resumed across the world and there is a decline in Covid-19 cases.