01 1North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN
02 1XELLIA PHARMACEUTICALS APS Copenhagen S DK
03 2ZHEJIANG TIANTAI PHARMACEUTICAL CO., LTD. Taizhou City CN
01 2Amphotericin B
02 1Amphotericin B, Process I
03 1Amphotericin B, Process II, for use in the manufacture of parenteral preparations
01 3China
02 1Denmark
01 4Valid
Certificate Number : R1-CEP 2005-212 - Rev 04
Status : Valid
Issue Date : 2023-08-17
Type : Chemical
Substance Number : 1292
Certificate Number : R1-CEP 2002-079 - Rev 09
Status : Valid
Issue Date : 2023-05-12
Type : Chemical
Substance Number : 1292
Certificate Number : CEP 2023-150 - Rev 00
Status : Valid
Issue Date : 2024-06-17
Type : Chemical
Substance Number : 1292
Amphotericin B, Process II, For Use In The Manuf...
Certificate Number : CEP 2023-152 - Rev 00
Status : Valid
Issue Date : 2024-07-03
Type : Chemical
Substance Number : 1292
A Amphotericin B manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amphotericin B, including repackagers and relabelers. The FDA regulates Amphotericin B manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amphotericin B 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 Amphotericin B manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amphotericin B supplier is an individual or a company that provides Amphotericin B active pharmaceutical ingredient (API) or Amphotericin B finished formulations upon request. The Amphotericin B suppliers may include Amphotericin B API manufacturers, exporters, distributors and traders.
click here to find a list of Amphotericin B suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amphotericin B CEP of the European Pharmacopoeia monograph is often referred to as a Amphotericin B Certificate of Suitability (COS). The purpose of a Amphotericin B CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amphotericin B EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amphotericin B to their clients by showing that a Amphotericin B CEP has been issued for it. The manufacturer submits a Amphotericin B CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amphotericin B CEP holder for the record. Additionally, the data presented in the Amphotericin B CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amphotericin B DMF.
A Amphotericin B CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amphotericin B 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 Amphotericin B suppliers with CEP (COS) on PharmaCompass.
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