Successful completion of USFDA inspection of API facility for Morepen Laboratories

Morepen Laboratories Limited has informed that the United States Food and Drug Administration (USFDA) conducted an inspection of its API manufacturing facility, at Baddi, Himachal Pradesh. The facility was cleared by USFDA on 24th March 2023 without any adverse observation (NIL 483).

USFDA conducted inspection at Pharmez facility of Zydus Lifesciences

Zydus Lifesciences Limited has informed that the USFDA conducted an inspection at the manufacturing facility SEZ-1 of Zydus Lifesciences Limited located at Pharmez, Ahmedabad from March 20-24, 2023. The inspection was a Pre-Approval Inspection (PAI) as well as a GMP Audit and concluded with three observations. There were no data integrity related observations. The company is addressing these observations and will respond to them within the stipulated time