01 1CONCORD BIOTECH LIMITED Ahmedabad IN
02 1HUBEI HONCH PHARMACEUTICAL CO., LTD. Huanggang CN
03 1TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL
04 1WUXI FORTUNE PHARMACEUTICAL CO., LTD. Wuxi CN
05 2Zhejiang Hisun Pharmaceutical Co., Ltd. Taizhou City CN
01 5Mitomycin
02 1Mitomycin, Alternative process
01 4China
02 1India
03 1Israel
01 5Valid
02 1Withdrawn by Holder
Certificate Number : R0-CEP 2019-308 - Rev 00
Status : Valid
Issue Date : 2021-02-25
Type : Chemical
Substance Number : 1655
Certificate Number : CEP 2022-400 - Rev 01
Status : Valid
Issue Date : 2024-04-26
Type : Chemical
Substance Number : 1655
Certificate Number : R1-CEP 2007-124 - Rev 04
Status : Valid
Issue Date : 2022-01-04
Type : Chemical
Substance Number : 1655
Certificate Number : R1-CEP 2016-034 - Rev 00
Status : Valid
Issue Date : 2022-11-09
Type : Chemical
Substance Number : 1655
Mitomycin, Alternative Process
Certificate Number : R1-CEP 2012-013 - Rev 00
Status : Valid
Issue Date : 2022-05-10
Type : Chemical
Substance Number : 1655
Certificate Number : R1-CEP 2005-021 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2011-01-25
Type : Chemical
Substance Number : 1655
A Mitomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitomycin, including repackagers and relabelers. The FDA regulates Mitomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitomycin 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 Mitomycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitomycin supplier is an individual or a company that provides Mitomycin active pharmaceutical ingredient (API) or Mitomycin finished formulations upon request. The Mitomycin suppliers may include Mitomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Mitomycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mitomycin CEP of the European Pharmacopoeia monograph is often referred to as a Mitomycin Certificate of Suitability (COS). The purpose of a Mitomycin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mitomycin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mitomycin to their clients by showing that a Mitomycin CEP has been issued for it. The manufacturer submits a Mitomycin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mitomycin CEP holder for the record. Additionally, the data presented in the Mitomycin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mitomycin DMF.
A Mitomycin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mitomycin 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 Mitomycin suppliers with CEP (COS) on PharmaCompass.
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