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Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
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01 2Evonik
02 1AMINO GmbH
03 3Ajinomoto Company
04 1KANEKA AMERICA CORP
05 1Kyowa Hakko Bio
06 2Mitsubishi Tanabe Pharma
07 1Nippon Kayaku
08 1Rexim SAS
09 1SHANGHAI KYOWA AMINO ACID CO., LTD.
10 1SIGMA TAU
11 1Summit Ingredients
12 1Blank
01 1China
02 1France
03 3Germany
04 8Japan
05 2U.S.A
06 1Blank
01 4Active
02 5Inactive
03 7Blank
01 7Valid
02 1Withdrawn by Holder
03 8Blank
01 1218MF10656
02 1218MF10975
03 1222MF10247
04 1222MF10252
05 1223MF10057
06 1229MF10074
07 10Blank
01 16Blank
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19769
Submission : 2006-08-28
Status : Active
Type : II
Certificate Number : R1-CEP 2004-086 - Rev 07
Issue Date : 2023-08-24
Type : Chemical
Substance Number : 752
Status : Valid
Registration Number : 218MF10975
Registrant's Address : No. 10 Wenjiang Road, Wuming District, Nanning, 530100, Guangxi, P. R. China
Initial Date of Registration : 2006-12-01
Latest Date of Registration : --
NDC Package Code : 16947-8204
Start Marketing Date : 2006-08-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 218MF10656
Registrant's Address : 33, Rue De Verdun Ham France
Initial Date of Registration : 2006-07-24
Latest Date of Registration : --
NDC Package Code : 16947-8204
Start Marketing Date : 2006-08-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 29142
Submission : 2015-02-23
Status : Active
Type : II
Certificate Number : CEP 2018-145 - Rev 01
Issue Date : 2023-12-20
Type : Chemical
Substance Number : 752
Status : Valid
Registration Number : 223MF10057
Registrant's Address : No. 718, Rongle East Road, Songjiang District, Shanghai, People's Republic of China
Initial Date of Registration : 2011-04-28
Latest Date of Registration : --
NDC Package Code : 51495-001
Start Marketing Date : 1998-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-30
Pay. Date : 2020-11-30
DMF Number : 31555
Submission : 2017-03-21
Status : Active
Type : II
Certificate Number : R1-CEP 2014-002 - Rev 00
Issue Date : 2020-10-20
Type : Chemical
Substance Number : 752
Status : Valid
Registration Number : 222MF10252
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2010-10-28
Latest Date of Registration : --
NDC Package Code : 51495-001
Start Marketing Date : 1998-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6875
Submission : 1987-03-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1804
Submission : 1971-09-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10617
Submission : 1993-10-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2621
Submission : 1976-03-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-013 - Rev 02
Issue Date : 2014-07-30
Type : Chemical
Substance Number : 752
Status : Valid
Registration Number : 222MF10247
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2010-10-28
Latest Date of Registration : --
NDC Package Code : 12497-1003
Start Marketing Date : 1978-05-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3283
Submission : 1978-07-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4814
Submission : 1982-12-20
Status : Inactive
Type : II
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