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Quality system

Charioteer has establish perfect quality management system and passed the quality related verification of ISO9001,ISO 14001 and OHSMS18001.Charioteer can manufacture API and totally 10 products had received registration numbers issued by CFDA, 8 products had passed GMP verification and most of our products had registered in FDA,EDMQ,Canada,Russian,Brazil,Japan,India and many other countries and regions.Charioteer have self-export right and more than 85% products are exported. The main products including Naproxen,Naproxen sodium ,Acyclovir, Clopidpgrel and other series. These products are equipped with mature process,advanced process technology.The capacity,sales and quality are ranked in advanced which regarded as an important API supplier.Charioteer had experienced 4 times of FDA inspection, 3 times of EDQM inspection ,3 times ANVISA inspection and so on.We also experienced many times of customer audit which contains many famous enterprise such as GSK,Bayer.

 

Date of Inspection

Date of Certificate issued

Product

Authority

Sept13 th-15th, 2007

December 15th, 2009

Naproxen, Acyclovir

EDQM

September 22nd-25th, 2008

January 11th,  2010

Naproxen, Naproxen Sodium, Acyclovir

FDA

US

June 29th-30th, 2009

July 22nd, 2009

Ketorolac Tromethamine

CFDA

China

December10 th-12th , 2009

February 09th, 2010

Naproxen, Naproxen Sodium, Isosorbide Mononitrate, Ganciclovir

CFDA

China

July 06th-07th, 2010

September 30th, 2010

Valacyclovir Hydrochloride

CFDA

China

March 30th-31st, 2011

May 04th, 2011

Clopidogrel Bisulfate

CFDA

China

April 04th-08th, 2011

January 09th, 2012

Naproxen, Naproxen Sodium,  Acyclovir

ANVISA

Brazil

September 12th-15th, 2011

February 13rd, 2012

Naproxen, Naproxen Sodium, Acyclovir, Valacyclovir Hydrochloride, Adefovir DMC, Irinotecan Hydrochloride

FDA

US

May 16th-18th, 2011

June 14th, 2011

Famciclovir

CFDA

China

November 14th -15th, 2011

Approved

Acyclovir

KFDA

Korea

September 06th-07th, 2012

Approved

Naproxen, Naproxen Sodium

KFDA

Korea

April 26th-28th, 2013

June 13th, 2013

Acyclovir

CFDA

China

November 18th - 22nd, 2013

February 14th, 2014

Acyclovir

ANVISA

Brazil

January 06th-10th, 2014

February 24th, 2014

Naproxen, Naproxen Sodium, Acyclovir, Ganciclovir,

Valacyclovir Hydrochloride,

Valganciclovir Hydrochloride

Mexico

COFEPRIS

June 30th  July 2nd,2014

December.17, 2014

Naproxen

EDQM

June 30thJuly 4th ,2014

November.25, 2014

Naproxen, Acyclovir, Naproxen Sodium, Valacyclovir Hydrochloride, Adefovir Dipivoxil DMC, Valganciclovir Hydrochloride, Naproxen Sodium Granule and Ganciclovir

FDA

April 27th- April 29th, 2015

July 7,2015

Valacyclovir Hydrochloride,

Clopidogrel Bisulfate

Famciclovir,Naproxen

Naproxen Sodium

CFDA

China

March 14th- March 18th 2016

April 18th 2016

Acyclovir

ANVISA

Brazil

March 21th- March 25th 2016

December 13th 2016  

Naproxen, Naproxen Sodium, Acyclovir, Ganciclovir,

Valacyclovir Hydrochloride,

Valganciclovir Hydrochloride

Clopidogrel Bisulfate

Mexico

COFEPRIS

July 5th- July 7th 2016

September.22,2016

Naproxen

MFDS

Korea

October 12th-14th 2016

Waiting

Acyclovir

EDQM