Regulatory Compliance
Regulatory Track Record - India Sites
Ankleshwar & Mandva Facilities (Gujarat, India)
8 Global Regulatory Audits 100% Compliance History
Global Accreditations & Approvals .png)
US FDA.png)
TGA Australia.png)
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WHO-GMP
US FDATGA AustraliaMFDS KoreaWHO-GMPUS FDA & MFDS inspection of the Ankleshwar facility
2013
US FDA inspection of the Mandva facility
2015
US FDA & Dept. of Health, Therapeutic Good Administration (TGA), Australia inspection of the Ankleshwar facility
2016
State FDA inspection of the Mandva facility
2020
CDSCO WHO-GMP inspection of the Ankleshwar & Mandva facilities
2021
State FDA inspection of the Ankleshwar facility
2022
US FDA inspection of the Ankleshwar facility
2023
US FDA inspection of the Mandva facility
2024
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