01 1AMINO GMBH Frellstedt DE
01 1N-Acetyltryptophan
01 1Germany
01 1Valid
Certificate Number : R0-CEP 2021-214 - Rev 00
Status : Valid
Issue Date : 2023-07-03
Type : Chemical
Substance Number : 1383
A N-ACETYL-DL-TRYPTOPHAN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-ACETYL-DL-TRYPTOPHAN, including repackagers and relabelers. The FDA regulates N-ACETYL-DL-TRYPTOPHAN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-ACETYL-DL-TRYPTOPHAN API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A N-ACETYL-DL-TRYPTOPHAN supplier is an individual or a company that provides N-ACETYL-DL-TRYPTOPHAN active pharmaceutical ingredient (API) or N-ACETYL-DL-TRYPTOPHAN finished formulations upon request. The N-ACETYL-DL-TRYPTOPHAN suppliers may include N-ACETYL-DL-TRYPTOPHAN API manufacturers, exporters, distributors and traders.
click here to find a list of N-ACETYL-DL-TRYPTOPHAN suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N-ACETYL-DL-TRYPTOPHAN CEP of the European Pharmacopoeia monograph is often referred to as a N-ACETYL-DL-TRYPTOPHAN Certificate of Suitability (COS). The purpose of a N-ACETYL-DL-TRYPTOPHAN CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of N-ACETYL-DL-TRYPTOPHAN EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of N-ACETYL-DL-TRYPTOPHAN to their clients by showing that a N-ACETYL-DL-TRYPTOPHAN CEP has been issued for it. The manufacturer submits a N-ACETYL-DL-TRYPTOPHAN CEP (COS) as part of the market authorization procedure, and it takes on the role of a N-ACETYL-DL-TRYPTOPHAN CEP holder for the record. Additionally, the data presented in the N-ACETYL-DL-TRYPTOPHAN CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the N-ACETYL-DL-TRYPTOPHAN DMF.
A N-ACETYL-DL-TRYPTOPHAN CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. N-ACETYL-DL-TRYPTOPHAN 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 N-ACETYL-DL-TRYPTOPHAN suppliers with CEP (COS) on PharmaCompass.
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