Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Evonik
03 1AMINO GmbH
04 2Ajinomoto Company
05 1Kyowa Hakko Bio
06 1Mitsubishi Tanabe Pharma
07 1Wuxi Jinghai Amino Acid Co Ltd
01 1China
02 3Germany
03 4Japan
01 1Active
02 2Inactive
03 5Blank
01 5Valid
02 1Withdrawn by Holder
03 2Blank
01 1218MF10967
02 1224MF10013
03 1227MF10116
04 5Blank
01 8Blank
Axplora- The partner of choice for complex APIs.
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Certificate Number : CEP 2010-155 - Rev 03
Issue Date : 2024-01-24
Type : Chemical
Substance Number : 2114
Status : Valid
Registration Number : 218MF10967
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2006-12-01
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31558
Submission : 2017-03-21
Status : Active
Type : II
Certificate Number : R1-CEP 2014-063 - Rev 02
Issue Date : 2023-08-10
Type : Chemical
Substance Number : 2114
Status : Valid
Registration Number : 227MF10116
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2015-04-21
Latest Date of Registration : --
NDC Package Code : 51495-024
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 : 1937
Submission : 1972-05-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31650
Submission : 2017-04-20
Status : Inactive
Type : II
Certificate Number : R1-CEP 2005-060 - Rev 01
Issue Date : 2015-02-12
Type : Chemical
Substance Number : 2114
Status : Withdrawn by Holder
NDC Package Code : 51495-024
Start Marketing Date : 2022-10-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2024-095 - Rev 01
Issue Date : 2024-09-27
Type : Chemical
Substance Number : 2114
Status : Valid
Certificate Number : CEP 2014-227 - Rev 01
Issue Date : 2023-10-26
Type : Chemical
Substance Number : 2114
Status : Valid
Registration Number : 224MF10013
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2012-01-18
Latest Date of Registration : --
NDC Package Code : 12497-1033
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 : R1-CEP 2016-042 - Rev 01
Issue Date : 2023-08-25
Type : Chemical
Substance Number : 2114
Status : Valid
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