Accreditations

Talent wins games, but teamwork and dedication wins championships

ACCREDITATIONS

Talent wins games, but teamwork and dedication wins championships.

Divi’s manufacturing units have been audited by several Health authorities like — FDA, EU GMP (UK, Slovenia, German, Irish authorities), HEALTH CANADA, TGA, ANVISA , COFEPRIS, PMDA and MFDS.
Divi’s manufacturing facilities have the Quality, Health and Safety management system certifications from ISO 9001, ISO 14001, ISO 14064,

ISO 18001, ISO 22000.

Divi’s has filed Drug Master Files for approximately 40 products with various health authorities.
Both the manufacturing units have undergone more than 30 cGMP audits by various regulatory authorities, 1700 Quality audits by various 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, BVQIInitial inspection in 2006 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule.
    OHSAS–18001:2007, BVQIInitial inspection in 2001 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule.

     

    UNIT – II
    Standard/Certification bodyInspection Year
    ISO–9001:2015, BVQIInitial inspection in 2003 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule.
    ISO–14001:2015 BVQIInitial inspection in 2003 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule.
    OHSAS –18001: 2007, BVQIInitial inspection in 2003 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 and 2016
    Japan – PMDA2011
    Korea – MFDS 2011
    Mexico – COFEPRIS2014
    Brazil – ANVISA2016

     

    UNIT – II
    Regulatory AuthorityInspection Year
    US – FDA2006, 2009, 2012, 2014, 2016, 2017 and 2019
    EU – GMP 2013, 2016, 2017 and 2019
    Japan – PMDA2017
    Canada – Health Canada2017
    Australia – TGA2012 and 2017
    Korea – MFDS2008, 2009 and 2014
    Mexico – COFEPRIS2014
    Name of the CompoundInitial DMF Filing Year
    Capecitabine2008
    Carbidopa2004
    Dextromethorphan Base2009
    Dextromethorphan HBr1997
    Diltiazem HCl2001
    Gabapentin2005
    Iopamidol2005
    Irbesartan2012
    Lacosamide2020
    Levetiracetam2003
    Levodopa2004
    Mesalamine2015
    Nabumetone2001
    Naproxen1998
    Naproxen Sodium1998
    Niacin2005
    Olmesartan Medoxomil2014
    Phenylephrine HCl2003
    Pregabalin2016
    Proguanil HCl2005
    Quetiapine Fumarate2007
    Telmisartan2012
    Ticagrelor2020
    Valacyclovir HCl (Hydrous form)2014
    Valsartan2011
    Venlafaxine HCl2009
    Vigabatrin2017