Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 2Evonik
02 1Ajinomoto Company
03 1Jing Jing Pharmaceutical
04 1Juzen Chemical Corporation
05 2Kyowa Hakko Bio
06 1Mitsubishi Tanabe Pharma
07 1Rexim SA
08 1SHANGHAI KYOWA AMINO ACID CO., LTD.
09 1SIGMA TAU
10 1Star Lake Bioscience Co., Inc.Zhaoqing
11 1Yangzhou Gami Biochem Co. Ltd
12 1Blank
01 3China
02 2Germany
03 6Japan
04 1Poland
05 1U.S.A
06 1Blank
01 2Active
02 3Inactive
03 9Blank
01 1Expired
02 5Valid
03 8Blank
01 1218MF10657
02 1218MF10964
03 1224MF10008
04 1224MF10012
05 1229MF10003
06 1229MF10028
07 1229MF10150
08 7Blank
01 14Blank
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26400
Submission : 2012-09-03
Status : Active
Type : II
Certificate Number : R1-CEP 2007-019 - Rev 02
Issue Date : 2022-04-06
Type : Chemical
Substance Number : 785
Status : Valid
Registration Number : 218MF10964
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2006-12-01
Latest Date of Registration : --
NDC Package Code : 51593-5012
Start Marketing Date : 1992-09-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registration Number : 218MF10657
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2006-07-24
Latest Date of Registration : --
NDC Package Code : 51593-5012
Start Marketing Date : 1992-09-03
End Marketing Date : 2025-12-31
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 : 31557
Submission : 2017-03-21
Status : Active
Type : II
Certificate Number : R1-CEP 1998-064 - Rev 04
Issue Date : 2018-05-17
Type : Chemical
Substance Number : 785
Status : Valid
Registration Number : 224MF10008
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2012-01-18
Latest Date of Registration : --
NDC Package Code : 51495-028
Start Marketing Date : 2022-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10063
Submission : 1993-01-26
Status : Inactive
Type : II
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 : 1805
Submission : 1971-09-24
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3668
Submission : 1979-12-20
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-047 - Rev 02
Issue Date : 2014-06-18
Type : Chemical
Substance Number : 785
Status : Valid
Registration Number : 229MF10150
Registrant's Address : 67 Gongnong Rd. , N. Zhaoqing City, Guangdong Province China, 526060
Initial Date of Registration : 2017-08-04
Latest Date of Registration : --
Certificate Number : CEP 2010-263 - Rev 01
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 785
Status : Valid
NDC Package Code : 74920-009
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
Certificate Number : R0-CEP 2001-404 - Rev 01
Issue Date : 2004-11-30
Type : Chemical
Substance Number : 785
Status : Expired
Certificate Number : R1-CEP 1999-018 - Rev 03
Issue Date : 2017-06-02
Type : Chemical
Substance Number : 785
Status : Valid
Registration Number : 229MF10028
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2017-02-08
Latest Date of Registration : --
A (L)-PROLINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (L)-PROLINE, including repackagers and relabelers. The FDA regulates (L)-PROLINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (L)-PROLINE API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A (L)-PROLINE supplier is an individual or a company that provides (L)-PROLINE active pharmaceutical ingredient (API) or (L)-PROLINE finished formulations upon request. The (L)-PROLINE suppliers may include (L)-PROLINE API manufacturers, exporters, distributors and traders.
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