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 2EVONIK REXIM S.A.S. Ham FR
03 1AMINO GMBH Frellstedt DE
04 2Ajinomoto Co., Inc. Tokyo JP
05 1KYOWA HAKKO BIO CO., LTD. Tokyo JP
06 1SERANA (WA) PTY. LTD. Bunbury AU
07 1SHANGHAI KYOWA AMINO ACID CO., LTD. Shanghai CN
01 1Foetal Calf Serum
02 5Serine
03 1Serine, Bio-enzymatic synthesis process
04 1Serine, Process II
05 1Serine, Wuming site
01 1Australia
02 1Gabon
03 3Germany
04 4Japan
01 8Valid
02 1Withdrawn 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 2014-366 - Rev 01
Status : Valid
Issue Date : 2023-08-24
Type : Chemical
Substance Number : 788
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!
Serine, Bio-enzymatic Synthesis Process
Certificate Number : R1-CEP 2007-020 - Rev 01
Status : Valid
Issue Date : 2014-03-21
Type : Chemical
Substance Number : 788
Certificate Number : R1-CEP 1999-159 - Rev 04
Status : Valid
Issue Date : 2018-05-17
Type : Chemical
Substance Number : 788
Certificate Number : R1-CEP 2013-211 - Rev 00
Status : Valid
Issue Date : 2019-06-21
Type : Chemical
Substance Number : 788
Certificate Number : R1-CEP 2006-315 - Rev 03
Status : Valid
Issue Date : 2020-10-26
Type : Chemical
Substance Number : 788
Certificate Number : R1-CEP 1999-019 - Rev 03
Status : Valid
Issue Date : 2016-11-09
Type : Chemical
Substance Number : 788
Certificate Number : R1-CEP 2008-303 - Rev 00
Status : Valid
Issue Date : 2014-06-23
Type : TSE
Substance Number :
Certificate Number : R1-CEP 2008-003 - Rev 00
Status : Valid
Issue Date : 2017-03-06
Type : Chemical
Substance Number : 788
Certificate Number : R1-CEP 1997-052 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2008-05-06
Type : Chemical
Substance Number : 788
A (L)-SERINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (L)-SERINE, including repackagers and relabelers. The FDA regulates (L)-SERINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (L)-SERINE 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)-SERINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (L)-SERINE supplier is an individual or a company that provides (L)-SERINE active pharmaceutical ingredient (API) or (L)-SERINE finished formulations upon request. The (L)-SERINE suppliers may include (L)-SERINE API manufacturers, exporters, distributors and traders.
click here to find a list of (L)-SERINE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (L)-SERINE CEP of the European Pharmacopoeia monograph is often referred to as a (L)-SERINE Certificate of Suitability (COS). The purpose of a (L)-SERINE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (L)-SERINE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (L)-SERINE to their clients by showing that a (L)-SERINE CEP has been issued for it. The manufacturer submits a (L)-SERINE CEP (COS) as part of the market authorization procedure, and it takes on the role of a (L)-SERINE CEP holder for the record. Additionally, the data presented in the (L)-SERINE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (L)-SERINE DMF.
A (L)-SERINE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (L)-SERINE 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)-SERINE suppliers with CEP (COS) on PharmaCompass.
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