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 1AMINO GMBH Frellstedt DE
03 3Ajinomoto Co., Inc. Tokyo JP
04 2EVONIK REXIM S.A.S. Ham FR
05 1KYOWA HAKKO BIO CO., LTD. Tokyo JP
06 1Rexim SAS Ham FR
07 1SHANGHAI KYOWA AMINO ACID CO., LTD. Shanghai CN
01 6Alanine
02 1Alanine, II
03 1Alanine, SA
04 1Phenylalanine, Fermentative origin
05 1Phenylalanine, Sulphate process
01 1France
02 1Gabon
03 3Germany
04 5Japan
01 1Expired
02 7Valid
03 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 : R1-CEP 2004-086 - Rev 07
Status : Valid
Issue Date : 2023-08-24
Type : Chemical
Substance Number : 752
Certificate Number : R1-CEP 1998-105 - Rev 05
Status : Valid
Issue Date : 2018-06-22
Type : Chemical
Substance Number : 752
Certificate Number : CEP 2018-145 - Rev 01
Status : Valid
Issue Date : 2023-12-20
Type : Chemical
Substance Number : 752
Certificate Number : R1-CEP 2014-002 - Rev 00
Status : Valid
Issue Date : 2020-10-20
Type : Chemical
Substance Number : 752
Certificate Number : CEP 2013-157 - Rev 02
Status : Valid
Issue Date : 2025-01-20
Type : Chemical
Substance Number : 752
Certificate Number : R1-CEP 1999-013 - Rev 02
Status : Valid
Issue Date : 2014-07-30
Type : Chemical
Substance Number : 752
Certificate Number : R1-CEP 1997-053 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2007-02-27
Type : Chemical
Substance Number : 752
Certificate Number : R1-CEP 2007-351 - Rev 01
Status : Valid
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 752
Phenylalanine, Fermentative Origin
Certificate Number : R1-CEP 2007-166 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2013-11-22
Type : Chemical
Substance Number : 782
Phenylalanine, Sulphate Process
Certificate Number : R0-CEP 2002-238 - Rev 03
Status : Expired
Issue Date : 2008-05-06
Type : Chemical
Substance Number : 782
34
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A ALANINE [USP MONOGRAPH] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ALANINE [USP MONOGRAPH], including repackagers and relabelers. The FDA regulates ALANINE [USP MONOGRAPH] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ALANINE [USP MONOGRAPH] 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 ALANINE [USP MONOGRAPH] supplier is an individual or a company that provides ALANINE [USP MONOGRAPH] active pharmaceutical ingredient (API) or ALANINE [USP MONOGRAPH] finished formulations upon request. The ALANINE [USP MONOGRAPH] suppliers may include ALANINE [USP MONOGRAPH] API manufacturers, exporters, distributors and traders.
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A ALANINE [USP MONOGRAPH] CEP of the European Pharmacopoeia monograph is often referred to as a ALANINE [USP MONOGRAPH] Certificate of Suitability (COS). The purpose of a ALANINE [USP MONOGRAPH] CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ALANINE [USP MONOGRAPH] EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ALANINE [USP MONOGRAPH] to their clients by showing that a ALANINE [USP MONOGRAPH] CEP has been issued for it. The manufacturer submits a ALANINE [USP MONOGRAPH] CEP (COS) as part of the market authorization procedure, and it takes on the role of a ALANINE [USP MONOGRAPH] CEP holder for the record. Additionally, the data presented in the ALANINE [USP MONOGRAPH] CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ALANINE [USP MONOGRAPH] DMF.
A ALANINE [USP MONOGRAPH] CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ALANINE [USP MONOGRAPH] CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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We have 6 companies offering ALANINE [USP MONOGRAPH]
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