Administrate
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 30th–July 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 |
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