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01 1EVONIK REXIM (NANNING) PHARMACEUTICAL CO., LTD. Nanning CN
02 2AMINO GMBH Frellstedt DE
03 2Ajinomoto Co., Inc. Tokyo JP
04 1KYOWA HAKKO BIO CO., LTD. Tokyo JP
05 1NEW ZEALAND PHARMACEUTICALS LTD. Palmerston North NZ
06 1SHANGHAI KYOWA AMINO ACID CO., LTD. Shanghai CN
07 1TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN
08 1WUXI JINGHAI AMINO ACID CO., LTD. Donggang Town CN
09 1YICHANG SANXIA PROUDIN BIOPHARMACEUTICAL CO., LTD. Yichang CN
01 1Bile powder, Standard and special bile
02 8Isoleucine
03 1Isoleucine, From Fermentation
04 1Isoleucine, SA
01 3China
02 1Gabon
03 2Germany
04 4Japan
05 1New Zealand
01 9Valid
02 2Withdrawn by Holder
Certificate Number : CEP 2008-098 - Rev 02
Status : Valid
Issue Date : 2023-10-18
Type : Chemical
Substance Number : 770
Certificate Number : R1-CEP 2013-296 - Rev 00
Status : Valid
Issue Date : 2020-08-14
Type : Chemical
Substance Number : 770
Certificate Number : R1-CEP 2004-228 - Rev 03
Status : Valid
Issue Date : 2021-06-17
Type : Chemical
Substance Number : 770
Certificate Number : R0-CEP 1998-041 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2002-02-01
Type : Chemical
Substance Number : 770
Certificate Number : R1-CEP 1999-014 - Rev 04
Status : Valid
Issue Date : 2020-08-14
Type : Chemical
Substance Number : 770
Bile Powder, Standard And Special Bile
Certificate Number : R1-CEP 2013-347 - Rev 01
Status : Valid
Issue Date : 2023-07-17
Type : TSE
Substance Number :
Certificate Number : R1-CEP 2010-188 - Rev 00
Status : Valid
Issue Date : 2017-02-08
Type : Chemical
Substance Number : 770
Certificate Number : R0-CEP 2020-206 - Rev 00
Status : Valid
Issue Date : 2022-10-21
Type : Chemical
Substance Number : 770
Certificate Number : CEP 2018-019 - Rev 01
Status : Valid
Issue Date : 2024-03-01
Type : Chemical
Substance Number : 770
Certificate Number : CEP 2023-047 - Rev 00
Status : Valid
Issue Date : 2023-12-01
Type : Chemical
Substance Number : 770
A Isoleucine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoleucine, including repackagers and relabelers. The FDA regulates Isoleucine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoleucine 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 Isoleucine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isoleucine supplier is an individual or a company that provides Isoleucine active pharmaceutical ingredient (API) or Isoleucine finished formulations upon request. The Isoleucine suppliers may include Isoleucine API manufacturers, exporters, distributors and traders.
click here to find a list of Isoleucine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isoleucine CEP of the European Pharmacopoeia monograph is often referred to as a Isoleucine Certificate of Suitability (COS). The purpose of a Isoleucine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isoleucine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isoleucine to their clients by showing that a Isoleucine CEP has been issued for it. The manufacturer submits a Isoleucine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isoleucine CEP holder for the record. Additionally, the data presented in the Isoleucine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isoleucine DMF.
A Isoleucine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isoleucine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Isoleucine suppliers with CEP (COS) on PharmaCompass.
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