Closure of USFDA inspection at Zydus' API Unit at Dabhasa, Gujarat

The inspection concluded with 6 observations and none of them were related to Data Integrity

Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s

Raichur site is the group’s largest API facility and part of a wider network of seven sites

OneSource Specialty Pharma updates on cGMP inspection by USFDA

The inspection has concluded with four observations

SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483

Indoco’s clinical research organisation ‘AnaCipher’ completes USFDA inspection

Korea’s MFDS completes inspection at Concord Biotech's Dholka unit

The inspection was successfully completed

Orchid Pharma's Alathur API facility successfully completes USFDA inspection

The Alathur facility specializes in the production of Cephalosporin antibiotics

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025

Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility

The site’s GMP Certification has been successfully renewed

Cenexi's Fontenay manufacturing facility receives 10 observations in ANSM inspection

Cenexi is committed to working closely with the ANSM to address the observations