Quality System

We believe in Quality By Design.
 
Lixin Pharmaceutical Company Limited has established a complete quality management system, delivered by the two executive organs QA and QC.
QC with professional analysts is responsible for the supervision of the quality of the products and research, and also responsible for performing inspection analysis, method verification and stability test for registered items all over the world.
Independent QA is focused on establishing strict and sound quality management system, to ensure all of process of manufacture are finished in accordance with GMP.?
Until now , four major products of Lixin have met cGMP from the first certification in December 2005.? Meanwhile, some of our products have applied FDA and European COS certificates.
Numbers

Time

Certifications

1

2005.12.

Obtained GMP certificate of Hydrochlorothiazide and Dacarbazine.

2

2007.12.

DMF of Hydrochlorothiazide have been submitted to FDA, registration No.21181

3

2008.06.

Obtained GMP certificate of idebenone

4

2009.01

Submitted European COS registration documents of Dacarbazine

5

2009.06

Obtained GMP certificate of indapamide

6

2009. 05.

Obtained Form-41 for Idebenone from DCGI

7

2010.10.

Passed US FDA on-site audit for Ritalinic acid
8 2010. 11 Submitted Indian registration applications for Indapamide, Hydrochlorothiazide and Dacarbazine.
9 2011.02 Re-validation of GMP certificates for Hydrochlorothiazide and Dacarbazine
10 2011. 06 Complete DMF for Pemetrexed Disodium and Clopidogrel Bisulfate Form-1
11 2011. 06 Start DMF filing for Oxaliplatin, obtained Form-41 for Indapamide from DCGI
12 2011.10 Obtain GMP certificate of Oxaliplatin
 
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