Marksans Pharma updates on USFDA inspection at Verna, Goa manufacturing facility

Briefs: Alkem Laboratories and Zydus Lifesciences

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant

Supriya Lifesciences received GMP certification from ANVISA Brazil

The clearance of this audit marks the successful registration of 8 APIs with CADIFA

Zydus Lifesciences' API site in Ahmedabad. receives 6 observations from USFDA

This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023

USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva

The company has received Form 483 with three observations

USFDA inspection at Piramal Pharma’s Bethlehem facility

USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA

InvaGen has received 5 inspectional observations in Form 483

Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time

Lonza launches nebula absorbance reader for streamlined Endotoxin and Pyrogen testing

The instrument is fully integrated with Lonza’s latest WinKQCLSoftware to enable data integrity compliance, streamline training, and reduce validation burden

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories