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 | |
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Standard/Certification body | Inspection Year |
ISO–9001:2015, SGS | Initial inspection in 1997 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
ISO–14001:2004, BVQI | Initial inspection in 2006 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
OHSAS–18001:2007, BVQI | Initial inspection in 2001 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
ISO – 45001: 2018, BVC | Initial inspection in 2019 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
UNIT – II | |
---|---|
Standard/Certification body | Inspection Year |
ISO–9001:2015, BVQI | Initial inspection in 2003 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
ISO–14001:2015 BVQI | Initial inspection in 2003 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
OHSAS –18001: 2007, BVQI | Initial inspection in 2003 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
UNIT – I | |
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Regulatory Authority | Inspection Year |
US – FDA | 2000, 2004, 2008, 2011, 2014, 2018 and 2019 |
EU – GMP | 2011 and 2016 |
Japan – PMDA | 2011 |
Korea – MFDS | 2011 |
Mexico – COFEPRIS | 2014 |
Brazil – ANVISA | 2016 |
UNIT – II | |
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Regulatory Authority | Inspection Year |
US – FDA | 2006, 2009, 2012, 2014, 2016, 2017 and 2019 |
EU – GMP | 2013, 2016, 2017 and 2019 |
Japan – PMDA | 2017 |
Canada – Health Canada | 2017 |
Australia – TGA | 2012 and 2017 |
Korea – MFDS | 2008, 2009 and 2014 |
Mexico – COFEPRIS | 2014 |
Name of the Compound | Initial DMF Filing Year |
---|---|
Capecitabine | 2008 |
Carbidopa | 2004 |
Dextromethorphan Base | 2009 |
Dextromethorphan HBr | 1997 |
Diltiazem HCl | 2001 |
Gabapentin | 2005 |
Iopamidol | 2005 |
Irbesartan | 2012 |
Lacosamide | 2020 |
Levetiracetam | 2003 |
Levodopa | 2004 |
Mesalamine | 2015 |
Nabumetone | 2001 |
Naproxen | 1998 |
Naproxen Sodium | 1998 |
Niacin | 2005 |
Olmesartan Medoxomil | 2014 |
Phenylephrine HCl | 2003 |
Pregabalin | 2016 |
Proguanil HCl | 2005 |
Quetiapine Fumarate | 2007 |
Telmisartan | 2012 |
Ticagrelor | 2020 |
Valacyclovir HCl (Hydrous form) | 2014 |
Valsartan | 2011 |
Venlafaxine HCl | 2009 |
Vigabatrin | 2017 |