Dishman Carbogen Amcis updates on USFDA inspection at its Bavla facility

The inspection was concluded with few procedural observations

USFDA conducts inspection at Alembic Pharmaceuticals' Panelav oncology formulation facility

The company will provide comprehensive response to USFDA for the observations

Shilpa Medicare updates on Europe GMP inspection at Unit 4, Jadcherla, Telangana

The company intends to respond to the two minor observations within the stipulated time

USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva

The company has received Form 483 with three observations

NATCO Pharma announces successful completion of USFDA inspection

NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023

Shilpa Medicare Unit IV, Jadcherla has cleared TGA, Australia GMP inspection

This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years

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

USFDA inspection at Piramal Pharma’s Bethlehem facility

Dishman Carbogen Amcis updates on inspection by EDQM and AIFA

The company's Bavla site was successfully jointly inspected by the EDQM and Italian Medicines Agency (AIFA)

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

InvaGen has received 5 inspectional observations in Form 483