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Accreditations

  • Divi’s manufacturing units have been audited by several health authorities, including the US FDA, EU GMP (UK, Slovenia, Germany, Ireland), Health Canada, TGA, ANVISA, COFEPRIS, PMDA, and MFDS.
  • Our facilities hold certifications for Quality, Health, and Safety Management Systems, including ISO 9001, ISO 14001, ISO 14064, ISO 18001, and ISO 22000.
  • Divi’s has filed Drug Master Files (DMFs) for over 40 products with various international regulatory agencies.
  • Both manufacturing units have successfully undergone 42 cGMP audits by regulatory bodies and over 2,000 quality audits conducted by global customers.
UNIT  I 
Standard/Certification BodyInspection Year
ISO–9001:2015, SGSInitial inspection in 1997 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule.
ISO–14001:2004, BVCInitial inspection in 2006 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule.
ISO – 45001: 2018, BVCInitial inspection in 2019 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule.
UNIT  II 
Standard/Certification BodyInspection Year
ISO–9001:2015, BVCInitial inspection in 2003 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule.
ISO–14001:2015, BVCInitial inspection in 2006 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule.
ISO – 45001: 2018, BVCInitial inspection in 2021 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule.
UNIT  I
Regulatory AuthorityInspection Year
US – FDA2000, 2004, 2008, 2011, 2014, 2018, and 2019
EU – GMP2011, 2016, and 2025
Health Canada2023
Japan – PMDA2011 and 2023
Korea – MFDS2011 and 2023
Mexico – COFEPRIS2014
Brazil – ANVISA2016

 

UNIT  II
Regulatory AuthorityInspection Year
US – FDA2006, 2009, 2012, 2014, 2016, 2017, 2019, 2020, and 2024
EU – GMP2013, 2016, 2017, 2019, and 2024
Japan – PMDA2017, 2025
Canada – Health Canada2017
Australia – TGA2012 and 2017
Korea – MFDS2008, 2009, 2014, and 2023
Mexico – COFEPRIS2014
Name of the CompoundInitial DMF Filing Year
Bupropion HCl2005
Capecitabine2008
Carbidopa2004
Dextromethorphan Base2009
Dextromethorphan HBr1997
Diltiazem HCl2001
Gabapentin2005
Iohexol2023
Iopamidol2005
Irbesartan2023
Lacosamide2021
Levetiracetam2003
Levodopa2004
Losartan Potassium2024
Mesalamine2015
Nabumetone2001
Naproxen1998
Naproxen Sodium1998
Niacin2005
Olmesartan Medoxomil2014
Orlistat2021
Phenylephrine HCl2003
Pregabalin2016
Proguanil HCl2005
Quetiapine Fumarate2007
Rivaroxaban2024
Telmisartan2012
Ticagrelor2022
Valacyclovir HCl (Hydrous form)2014
Valsartan2011
Venlafaxine HCl2009
Vigabatrin2017