USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations

USFDA completes inspection at Biocon Biologics’ facilities in Bengaluru

The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants

Briefs: Zydus Lifesciences and Divi's Laboratories

Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets

USFDA inspection at Biocon Biologics' manufacturing facility in Johor, Malaysia

Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad

The inspection was a cGMP Inspection and had ended with NIL observations

Briefs: Neuland Laboratories, Cipla and Zydus

Cipla has received 8 inspectional observations in Form 483

Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod

The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs