Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 2Evonik
02 1AMINO GmbH
03 2Ajinomoto Company
04 1Daiichi Sankyo
05 1Kyowa Hakko Bio
06 1Mitsubishi Tanabe Pharma
07 1SHANGHAI KYOWA AMINO ACID CO., LTD.
08 1SIGMA TAU
09 1SNJ Labs
10 1Yangzhou Gami Biochem Co. Ltd
01 1China
02 3Germany
03 1India
04 6Japan
05 1U.S.A
01 4Active
02 3Inactive
03 5Blank
01 5Valid
02 7Blank
01 1217MF10232
02 1217MF10376
03 1218MF10966
04 1226MF10085
05 1231MF10069
06 7Blank
01 12Blank
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 231MF10069
Registrant's Address : No. 10 Wenjiang Road, Wuming District, Nanning, 530100, Guangxi, P. R. China
Initial Date of Registration : 2019-03-11
Latest Date of Registration : --
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 218MF10966
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2006-12-01
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38244
Submission : 2023-04-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4033
Submission : 1980-10-22
Status : Active
Type : II
Certificate Number : R1-CEP 2006-160 - Rev 01
Issue Date : 2014-08-12
Type : Chemical
Substance Number : 782
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 29140
Submission : 2015-02-23
Status : Active
Type : II
Certificate Number : R1-CEP 2014-132 - Rev 00
Issue Date : 2020-07-20
Type : Chemical
Substance Number : 782
Status : Valid
Registration Number : 226MF10085
Registrant's Address : No. 718, Rongle East Road, Songjiang District, Shanghai, People's Republic of China
Initial Date of Registration : 2014-05-09
Latest Date of Registration : --
NDC Package Code : 17333-927
Start Marketing Date : 2002-06-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31652
Submission : 2017-04-20
Status : Active
Type : II
Certificate Number : R1-CEP 1998-067 - Rev 02
Issue Date : 2014-10-17
Type : Chemical
Substance Number : 782
Status : Valid
Registration Number : 217MF10376
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-07-27
Latest Date of Registration : --
NDC Package Code : 17333-927
Start Marketing Date : 2002-06-30
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 : 9993
Submission : 1992-11-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1273
Submission : 1968-12-27
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-084 - Rev 03
Issue Date : 2014-08-06
Type : Chemical
Substance Number : 782
Status : Valid
Registration Number : 217MF10232
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration : --
NDC Package Code : 12497-1024
Start Marketing Date : 1978-03-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Certificate Number : CEP 2010-225 - Rev 03
Issue Date : 2024-06-14
Type : Chemical
Substance Number : 782
Status : Valid
NDC Package Code : 74920-008
Start Marketing Date : 2020-03-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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