Lupin’s API, finished product facility in M.P. gets U.S. FDA observations 

The U.S. Food and Drug Administration has issued six observations to Lupin after an inspection of the drugmaker’s active pharmaceutical ingredient (API) and finished product manufacturing facility in Pithampur, Madhya Pradesh.

“The inspection closed with three observations each on the API and finished product side,” Lupin said in a filing on Saturday. The U.S. FDA had the inspected the facility (Unit-1) from September 16-27. “We are addressing the observations comprehensively and will respond to the U.S. FDA within the stipulated timeframe,” the company said.

Published - September 28, 2024 08:04 pm IST