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Results For "GMP-inspection"

53 News Found

Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod
Biotech | May 29, 2022

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


HPRA completes audit of Biocon Biologics New mAbs drug substance facility
Biotech | May 04, 2022

HPRA completes audit of Biocon Biologics New mAbs drug substance facility

The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency


Shilpa Medicare Jadcherla facility gets GMP certification from Russia
Policy | May 29, 2021

Shilpa Medicare Jadcherla facility gets GMP certification from Russia

The GMP certificate is valid for three years until April 2024.