Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 2Evonik
02 1AMINO GmbH
03 3Ajinomoto Company
04 2Kyowa Hakko Bio
05 2Mitsubishi Tanabe Pharma
06 1SHANGHAI KYOWA AMINO ACID CO., LTD.
07 1SIGMA TAU
08 1Summit Ingredients
09 1Yangzhou Gami Biochem Co. Ltd
01 2China
02 3Germany
03 8Japan
04 1U.S.A
01 3Active
02 3Inactive
03 8Blank
01 7Valid
02 7Blank
01 1217MF10229
02 1218MF10659
03 1218MF10907
04 1218MF10965
05 1220MF10073
06 1226MF10004
07 8Blank
01 14Blank
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Certificate Number : R1-CEP 2004-310 - Rev 02
Issue Date : 2014-03-06
Type : Chemical
Substance Number : 1049
Status : Valid
Registration Number : 218MF10965
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2006-12-01
Latest Date of Registration : --
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 218MF10659
Registrant's Address : 33, Rue de Verdun Ham France
Initial Date of Registration : 2006-07-24
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34526
Submission : 2020-03-27
Status : Active
Type : II
Certificate Number : R1-CEP 2004-277 - Rev 03
Issue Date : 2023-08-25
Type : Chemical
Substance Number : 1049
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 29306
Submission : 2015-04-17
Status : Active
Type : II
Certificate Number : R1-CEP 1996-097 - Rev 07
Issue Date : 2018-05-17
Type : Chemical
Substance Number : 1049
Status : Valid
Registration Number : 220MF10073
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2008-03-14
Latest Date of Registration : --
NDC Package Code : 51495-830
Start Marketing Date : 2022-10-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-30
Pay. Date : 2020-11-30
DMF Number : 31564
Submission : 2017-03-21
Status : Active
Type : II
Certificate Number : R1-CEP 2014-204 - Rev 01
Issue Date : 2021-09-27
Type : Chemical
Substance Number : 1049
Status : Valid
Registration Number : 218MF10907
Registrant's Address : No. 718, Rongle East Road, Songjiang District, Shanghai, People's Republic of China
Initial Date of Registration : 2006-11-10
Latest Date of Registration : --
NDC Package Code : 51495-830
Start Marketing Date : 2022-10-01
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 : 9992
Submission : 1992-11-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1248
Submission : 1968-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10061
Submission : 1993-01-26
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-044 - Rev 00
Issue Date : 2017-02-07
Type : Chemical
Substance Number : 1049
Status : Valid
NDC Package Code : 74920-011
Start Marketing Date : 2020-03-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Certificate Number : R1-CEP 1999-015 - Rev 02
Issue Date : 2014-07-02
Type : Chemical
Substance Number : 1049
Status : Valid
Registration Number : 226MF10004
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2014-01-08
Latest Date of Registration : --
NDC Package Code : 12497-1016
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
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