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01 2Evonik
02 2Ajinomoto Company
03 1Emeishan Hongsen Biopharma
04 1Grand Pharma
05 1Jing Jing Pharmaceutical
06 1Juzen Chemical Corporation
07 2Kyowa Hakko Bio
08 1Mitsubishi Tanabe Pharma
09 1Rexim SA
10 1SIGMA TAU
11 1Star Lake Bioscience Co., Inc.Zhaoqing
12 1Tianjin Tianfa Pharmaceutical Import & Export
13 1Yangzhou Gami Biochem Co. Ltd
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01 6China
02 2Germany
03 6Japan
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01 2Active
02 3Inactive
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01 1Expired
02 5Valid
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01 1218MF10657
02 1218MF10964
03 1224MF10008
04 1224MF10012
05 1229MF10003
06 1229MF10028
07 1229MF10150
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01 151495-028
02 151495-828
03 151593-5012
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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 : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 218MF10657
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2006-07-24
Latest Date of Registration :
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10063
Submission : 1993-01-26
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 :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2010-263 - Rev 02
Issue Date : 2025-10-08
Type : Chemical
Substance Number : 785
Status : Valid

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 :

Certificate Number : R0-CEP 2001-404 - Rev 01
Issue Date : 2004-11-30
Type : Chemical
Substance Number : 785
Status : Expired

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PharmaCompass offers a list of Proline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Proline manufacturer or Proline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Proline manufacturer or Proline supplier.
A Proline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Proline, including repackagers and relabelers. The FDA regulates Proline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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.
click here to find a list of Proline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Proline supplier is an individual or a company that provides Proline active pharmaceutical ingredient (API) or Proline finished formulations upon request. The Proline suppliers may include Proline API manufacturers, exporters, distributors and traders.
click here to find a list of Proline suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 13 companies offering Proline
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