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GMP compliance

Sites

Time

Inspections

HEC Pharm Co.,Ltd.,

in Hubei, China

Feb-2007,

Jun-2011,

Sep-2013

CN CFDA GMP

Apr-2012

Mar-2015 (planned)

US FDA cGMP

Nov-2012

EU GMP

Oct-2012

KR KFDA GMP

Apr-2013,

Jan-2014

WHO GMP

May-2013

JP PMDA GMP


Sites

Time

Inspections

Yichang Changjiang

Pharmaceutical Co., Ltd.,

in Hubei, China

Feb-2010,

Jun-2010,

Nov-2011

May-2012

Sep-2013

Feb, Apr, Jun-2014

CN CFDA GMP

May-2011

Mar-2015 (planned)

US FDA cGMP

Jan-2014

WHO GMP


Sites

Time

Inspections

Sunshine Lake

Pharma Co., Ltd.,

in Guangdong, China

Jul-2006,

Jul-2009,

Jan-2010,

Apr-2014 (tablets)

Nov-2014 (capsules)

CN CFDA GMP

Jul-2007,

Sep-2009,

Nov-2012

EU GMP

Jul-2011,

Mar-2014

US FDA cGMP

Oct-2012

Under reviewing

AU TGA GMP

Apr-2013,

Jan-2014

WHO GMP




Sites

Time

Inspections

Ruyuan HEC Co., Ltd.,

in Guangdong, China

Sep-2015

US FDA GMP
May-2016EU GMP
Jul-2017KR MFDS GMP

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