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 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.

 

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
Regulatory Authority Inspection Year
US – FDA 2000, 2004, 2008, 2011,2014 and 2018
EU – GMP 2011 and 2016
Japan – PMDA 2011
Korea – MFDS                        2011
Mexico – COFEPRIS 2014
Brazil – ANVISA 2016

 

UNIT – II
Regulatory Authority Inspection Year
US – FDA 2006, 2009, 2012, 2014 ,2016 and 2017
EU – GMP 2013,2016 and 2017
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
Fosphenytoin Sodium 2005
Gabapentin 2005
Iopamidol 2005
Irbesartan 2012
Lacosamide 2019
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
Ranolazine 2019
Tamsulosin HCl 2005
Telmisartan 2012
Ticagrelor 2019
Valacyclovir HCl (Hydrous form) 2014
Valsartan 2011
Venlafaxine HCl 2009
Vigabatrin 2017