Axplora- The partner of choice for complex APIs.
01 1Axplora
02 2Ajinomoto Company
03 1Apotex Pharmachem
04 1Chifeng Arker Pharmaceutical Technology Co. Ltd.
05 1Corden Pharma Bergamo S.p.A
06 1Formosa Laboratories
07 1Ipca Laboratories
08 1Olon S.p.A
09 1Signa S.A. de C.V.
10 1Unipex
11 1Blank
01 1Canada
02 1China
03 1France
04 1Germany
05 1India
06 2Italy
07 2Japan
08 1Mexico
09 1Taiwan
10 1Blank
01 3Active
02 7Inactive
03 2Blank
01 12Blank
01 12Blank
01 1WC-0102
02 11Blank
Axplora- The partner of choice for complex APIs.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-10
Pay. Date : 2021-08-06
DMF Number : 16425
Submission : 2003-02-17
Status : Active
Type : II
Date of Issue : 2022-06-24
Valid Till : 2025-07-02
Written Confirmation Number : WC-0102
Address of the Firm :
NDC Package Code : 12598-6026
Start Marketing Date : 2004-08-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
| Available Reg Filing : EU |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-24
Pay. Date : 2013-04-30
DMF Number : 18894
Submission : 2005-10-21
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-07
Pay. Date : 2013-07-30
DMF Number : 17326
Submission : 2004-04-19
Status : Active
Type : II
NDC Package Code : 66499-0004
Start Marketing Date : 2006-06-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2015-05-27
Registration Number : Number 2397-2-ND
Manufacturer Name : Formosa Laboratories, Inc.
Manufacturer Address : 36, Hoping Street, Louchu, Taoyuan 33842, Taiwan_x000D_
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18573
Submission : 2005-05-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17500
Submission : 2004-06-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12287
Submission : 1996-12-20
Status : Inactive
Type : II
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2005-06-10
Registration Number : 12-1-ND
Manufacturer Name : SA Ajinomoto Omnichem NV
Manufacturer Address : SA Ajinomoto Omnichem NV Cooppallaan 91 B-9230 Wettern, Belgium
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16256
Submission : 2003-01-02
Status : Inactive
Type : II
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2005-06-10
Registration Number : 12-1-ND
Manufacturer Name : SA Ajinomoto Omnichem NV
Manufacturer Address : SA Ajinomoto Omnichem NV Cooppallaan 91 B-9230 Wettern, Belgium
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17780
Submission : 2004-10-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19684
Submission : 2006-08-03
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12289
Submission : 1996-12-18
Status : Inactive
Type : II
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