Zydus Lifesciences gets 4 observations from USFDA for Moraiya facility

The USFDA conducted an inspection of Zydus Lifesciences Ltd's Moraiya manufacturing facility located at Ahmedabad from 26th July to 5th August, 2022. The inspection concluded with four Form 483 observations. None of the observations were related to data integrity. The company will address the observations within the stipulated timeline.

Kimia Biosciences receives DMF approval from Korea

Kimia Biosciences Ltd has received DMF approval of Fimasartan Potassium Trihydrate, Active Pharmaceutical Ingredients (API) from Korea.