USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI

The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants

Briefs: Sun Pharmaceutical Industries and Biocon Biologics

The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI

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