Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik
02 2AMINO GmbH
03 2Ajinomoto Company
04 1Kyowa Hakko Bio
05 2Mitsubishi Tanabe Pharma
06 1New Zealand Pharmaceuticals Ltd
07 1Nippon Kayaku
08 1SHANGHAI KYOWA AMINO ACID CO., LTD.
09 1SIGMA TAU
10 1SNJ Labs
11 1Shine Star Hubei Biological Engineering
12 1Summit Ingredients
13 1Taenaka Kogyo
14 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
15 1Wuxi Jinghai Amino Acid Co Ltd
16 1Yangzhou Gami Biochem Co. Ltd
17 1Yichang Sanxia Proudin Biopharmaceutical
18 1Blank
01 6China
02 3Germany
03 1India
04 8Japan
05 1New Zealand
06 1U.S.A
07 1Blank
01 4Active
02 5Inactive
03 12Blank
01 9Valid
02 2Withdrawn by Holder
03 10Blank
01 1217MF10221
02 1217MF10288
03 1218MF10978
04 1219MF10243
05 1226MF10084
06 1229MF10079
07 1305MF10063
08 14Blank
01 21Blank
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Certificate Number : CEP 2008-098 - Rev 02
Issue Date : 2023-10-18
Type : Chemical
Substance Number : 770
Status : Valid
Registration Number : 218MF10978
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 : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-14
Pay. Date : 2018-07-05
DMF Number : 21991
Submission : 2008-07-17
Status : Active
Type : II
Certificate Number : R1-CEP 2013-296 - Rev 00
Issue Date : 2020-08-14
Type : Chemical
Substance Number : 770
Status : Valid
Registration Number : 226MF10084
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 : 72012-820
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 : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 29143
Submission : 2015-02-23
Status : Active
Type : II
Certificate Number : R1-CEP 1998-122 - Rev 03
Issue Date : 2013-09-25
Type : Chemical
Substance Number : 770
Status : Withdrawn by Holder
Registration Number : 219MF10243
Registrant's Address : Avenida Oriento, s/n Bairro Entre Rios-CEP 18500-000, Laranjal Paulista, SP, Brazil
Initial Date of Registration : 2007-07-17
Latest Date of Registration : --
NDC Package Code : 72012-820
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 : 38242
Submission : 2023-04-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4041
Submission : 1980-10-22
Status : Active
Type : II
Certificate Number : R1-CEP 2004-228 - Rev 03
Issue Date : 2021-06-17
Type : Chemical
Substance Number : 770
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2623
Submission : 1976-02-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-014 - Rev 04
Issue Date : 2020-08-14
Type : Chemical
Substance Number : 770
Status : Valid
Registration Number : 217MF10221
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration : --
NDC Package Code : 12497-1008
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4822
Submission : 1982-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1250
Submission : 1968-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9422
Submission : 1991-11-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9991
Submission : 1992-11-25
Status : Inactive
Type : II
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