01 1NIPPON KAYAKU CO., LTD. Tokyo JP
02 1TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL
03 2Zhejiang Hisun Pharmaceutical Co., Ltd. Taizhou City CN
01 3Bleomycin Sulfate
02 1Bleomycin Sulfate, Alternative process
01 2China
02 1Israel
03 1Japan
01 3Valid
02 1Withdrawn by Holder
Certificate Number : CEP 2002-149 - Rev 05
Status : Valid
Issue Date : 2023-12-12
Type : Chemical
Substance Number : 976
Certificate Number : CEP 2021-272 - Rev 01
Status : Valid
Issue Date : 2024-06-28
Type : Chemical
Substance Number : 976
Bleomycin Sulfate, Alternative Process
Certificate Number : R1-CEP 2012-197 - Rev 00
Status : Valid
Issue Date : 2022-05-10
Type : Chemical
Substance Number : 976
Certificate Number : R1-CEP 2001-422 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2012-06-05
Type : Chemical
Substance Number : 976
A Bleomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bleomycin, including repackagers and relabelers. The FDA regulates Bleomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bleomycin 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 Bleomycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bleomycin supplier is an individual or a company that provides Bleomycin active pharmaceutical ingredient (API) or Bleomycin finished formulations upon request. The Bleomycin suppliers may include Bleomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Bleomycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bleomycin CEP of the European Pharmacopoeia monograph is often referred to as a Bleomycin Certificate of Suitability (COS). The purpose of a Bleomycin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bleomycin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bleomycin to their clients by showing that a Bleomycin CEP has been issued for it. The manufacturer submits a Bleomycin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bleomycin CEP holder for the record. Additionally, the data presented in the Bleomycin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bleomycin DMF.
A Bleomycin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bleomycin 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 Bleomycin suppliers with CEP (COS) on PharmaCompass.
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