Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1EVONIK REXIM (NANNING) PHARMACEUTICAL CO., LTD. Nanning CN
02 3AMINO GMBH Frellstedt DE
03 3Ajinomoto Co., Inc. Tokyo JP
04 1KYOWA HAKKO BIO CO., LTD. Tokyo JP
05 1SHANGHAI KYOWA AMINO ACID CO., LTD. Shanghai CN
06 1TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN
07 1Welding GmbH & Co. KG Hamburg DE
08 1YICHANG SANXIA PROUDIN BIOPHARMACEUTICAL CO., LTD. Yichang CN
01 10Leucine
02 1Leucine, From feathers
03 1Leucine, Obtained from fermentation
01 2China
02 1Gabon
03 4Germany
04 5Japan
01 10Valid
02 2Withdrawn by Holder
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Certificate Number : CEP 2008-097 - Rev 02
Status : Valid
Issue Date : 2023-11-02
Type : Chemical
Substance Number : 771
Certificate Number : R1-CEP 2008-233 - Rev 01
Status : Valid
Issue Date : 2018-05-17
Type : Chemical
Substance Number : 771
Certificate Number : R1-CEP 2012-052 - Rev 01
Status : Valid
Issue Date : 2023-03-08
Type : Chemical
Substance Number : 771
Certificate Number : R1-CEP 2014-088 - Rev 00
Status : Valid
Issue Date : 2019-12-06
Type : Chemical
Substance Number : 771
Leucine, Obtained From Fermentation
Certificate Number : R1-CEP 2014-156 - Rev 00
Status : Valid
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 771
Certificate Number : R1-CEP 1997-011 - Rev 04
Status : Valid
Issue Date : 2013-11-13
Type : Chemical
Substance Number : 771
Certificate Number : R1-CEP 1999-160 - Rev 03
Status : Valid
Issue Date : 2013-08-30
Type : Chemical
Substance Number : 771
Certificate Number : R1-CEP 2010-189 - Rev 00
Status : Valid
Issue Date : 2017-01-31
Type : Chemical
Substance Number : 771
Certificate Number : R0-CEP 2020-207 - Rev 00
Status : Valid
Issue Date : 2022-10-21
Type : Chemical
Substance Number : 771
Certificate Number : CEP 2023-459 - Rev 00
Status : Valid
Issue Date : 2024-06-25
Type : Chemical
Substance Number : 771
A L-Leucine API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Leucine API, including repackagers and relabelers. The FDA regulates L-Leucine API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Leucine API 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 L-Leucine API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Leucine API supplier is an individual or a company that provides L-Leucine API active pharmaceutical ingredient (API) or L-Leucine API finished formulations upon request. The L-Leucine API suppliers may include L-Leucine API API manufacturers, exporters, distributors and traders.
click here to find a list of L-Leucine API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Leucine API CEP of the European Pharmacopoeia monograph is often referred to as a L-Leucine API Certificate of Suitability (COS). The purpose of a L-Leucine API CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Leucine API EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Leucine API to their clients by showing that a L-Leucine API CEP has been issued for it. The manufacturer submits a L-Leucine API CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Leucine API CEP holder for the record. Additionally, the data presented in the L-Leucine API CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Leucine API DMF.
A L-Leucine API CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Leucine API 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 L-Leucine API suppliers with CEP (COS) on PharmaCompass.
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