01 1Fujian Fukang Pharmaceutical Co., Ltd. Fuzhou City CN
02 1LEK PHARMACEUTICALS D.D. Ljubljana SI
01 2Gentamicin sulfate
01 1China
02 1Slovenia
01 2Valid
Certificate Number : R1-CEP 1998-155 - Rev 10
Status : Valid
Issue Date : 2019-02-18
Type : Chemical
Substance Number : 331
Certificate Number : CEP 2005-121 - Rev 02
Status : Valid
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 331
A Gentamicin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gentamicin, including repackagers and relabelers. The FDA regulates Gentamicin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gentamicin 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 Gentamicin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gentamicin supplier is an individual or a company that provides Gentamicin active pharmaceutical ingredient (API) or Gentamicin finished formulations upon request. The Gentamicin suppliers may include Gentamicin API manufacturers, exporters, distributors and traders.
click here to find a list of Gentamicin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gentamicin CEP of the European Pharmacopoeia monograph is often referred to as a Gentamicin Certificate of Suitability (COS). The purpose of a Gentamicin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gentamicin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gentamicin to their clients by showing that a Gentamicin CEP has been issued for it. The manufacturer submits a Gentamicin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gentamicin CEP holder for the record. Additionally, the data presented in the Gentamicin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gentamicin DMF.
A Gentamicin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gentamicin 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 Gentamicin suppliers with CEP (COS) on PharmaCompass.
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