KONGO

  Kongo Chemical co.,Ltd contributes to human healthcare as an innovative and skilled API-manufacturer.

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Quality assurance

「 Guarantee the quality 」,「 Safe and secure 」, 「 The latest information 」,「 Clear responsibilities 」
We always consider the patients,and will continue to supply products.



Good manufacturing practice organization

Good manufacturing practice organization



Global operations

We will work to improve the high quality,under the strict quality control based on the GMP.
Kongo experienced many periodical FDA-inspections

Active US-DMFs

Products Registration number
Diphenhydramine Hydrochloride US-DMF No.3879
Chlorpheniramine Maleate US-DMF No.3885
Dexchlorpheniramaine Maleate US-DMF No.4688
Pheniramaine Maleate US-DMF No.8960
Carbinoxamine Maleate US-DMF No.9844

Active CEP

Products Registration number
Chlorpheniramine Maleate CEP No.R1-CEP2006-151-Rev00
Dexchlorpheniramine Maleate CEP No.R0-CEP2014-124-Rev01



Quality Control

For highly trusted, we do the tests and inspections.
+「 education and training 」+「 corresponding to the cGMP 」
SOP will review as appropriate, and We aim to improve test quality.

Our test equipments

Test equipments
Number of
Gas chromatograph
13
High performance liquid chromatograph
28
Induction coupled plasma mass analyzer (ICP/MS)
1
Infrared spectrophotometer
3
Spectrophotometer
2
Moisture measurement apparatus
5

We are working on experiments

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