Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik
02 1AMINO GmbH
03 2Ajinomoto Company
04 1Daiichi Sankyo
05 1Hengdian Group
06 1Kyowa Hakko Bio
07 1Mitsubishi Tanabe Pharma
08 1SIGMA TAU
09 1Showa Denko
10 1Upsher-Smith Laboratories
11 1Yangzhou Gami Biochem Co. Ltd
12 1Zhejiang Chemvplus Biotech Co. Ltd
13 1Blank
01 3China
02 2Germany
03 6Japan
04 2U.S.A
05 1Blank
01 2Active
02 7Inactive
03 5Blank
01 3Valid
02 1Withdrawn by Holder
03 10Blank
01 1217MF10228
02 1220MF10074
03 1227MF10115
04 1306MF10053
05 10Blank
01 14Blank
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Certificate Number : R1-CEP 2009-388 - Rev 00
Issue Date : 2017-06-08
Type : Chemical
Substance Number : 1272
Status : Withdrawn by Holder
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-01
Pay. Date : 2020-11-27
DMF Number : 8282
Submission : 1989-10-24
Status : Active
Type : II
Certificate Number : R1-CEP 1999-050 - Rev 06
Issue Date : 2014-09-18
Type : Chemical
Substance Number : 1272
Status : Valid
Registration Number : 306MF10053
Registrant's Address : An der Zucker-Raffinerie 9, 38373 Frellstedt, Germany
Initial Date of Registration : 2024-04-10
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31560
Submission : 2017-03-21
Status : Active
Type : II
Certificate Number : CEP 1998-137 - Rev 06
Issue Date : 2024-02-12
Type : Chemical
Substance Number : 1272
Status : Valid
Registration Number : 227MF10115
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 : 51495-731
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 : 2342
Submission : 1974-10-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1252
Submission : 1968-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6498
Submission : 1986-07-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5530
Submission : 1984-09-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2247
Submission : 1974-03-12
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-189 - Rev 03
Issue Date : 2022-12-05
Type : Chemical
Substance Number : 1272
Status : Valid
Registration Number : 217MF10228
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration : --
NDC Package Code : 12497-1019
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
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 : 3070
Submission : 1977-11-23
Status : Inactive
Type : II
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