01 1KRKA, d.d., Novo mesto Novo mesto SI
02 1North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN
03 3XELLIA PHARMACEUTICALS APS Copenhagen S DK
01 1Bacitracin
02 2Bacitracin zinc
03 1Bacitracin, Micronised, non-micronised
04 1Bacitracin, Sterile
01 1China
02 3Denmark
03 1Slovenia
01 4Valid
02 1Withdrawn by Holder
Certificate Number : R0-CEP 2006-052 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2008-11-07
Type : Chemical
Substance Number : 466
Certificate Number : CEP 2017-293 - Rev 01
Status : Valid
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 465
Bacitracin, Micronised, Non-micronised
Certificate Number : CEP 2002-226 - Rev 08
Status : Valid
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 465
Certificate Number : R1-CEP 2002-103 - Rev 10
Status : Valid
Issue Date : 2022-08-18
Type : Chemical
Substance Number : 466
Certificate Number : R1-CEP 2002-224 - Rev 08
Status : Valid
Issue Date : 2018-02-07
Type : Chemical
Substance Number : 465
A Bacitracin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bacitracin, including repackagers and relabelers. The FDA regulates Bacitracin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bacitracin 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 Bacitracin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bacitracin supplier is an individual or a company that provides Bacitracin active pharmaceutical ingredient (API) or Bacitracin finished formulations upon request. The Bacitracin suppliers may include Bacitracin API manufacturers, exporters, distributors and traders.
click here to find a list of Bacitracin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bacitracin CEP of the European Pharmacopoeia monograph is often referred to as a Bacitracin Certificate of Suitability (COS). The purpose of a Bacitracin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bacitracin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bacitracin to their clients by showing that a Bacitracin CEP has been issued for it. The manufacturer submits a Bacitracin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bacitracin CEP holder for the record. Additionally, the data presented in the Bacitracin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bacitracin DMF.
A Bacitracin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bacitracin 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 Bacitracin suppliers with CEP (COS) on PharmaCompass.
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