01 1CIPLA LIMITED Mumbai IN
02 1Chongqing Carelife Pharmaceutical Co. Ltd. Chongqing CN
03 1SICOR DE MEXICO SA DE CV Lerma MX
01 3Mitoxantrone hydrochloride
01 1China
02 1India
03 1Mexico
01 2Valid
02 1Withdrawn by Holder
Certificate Number : R1-CEP 2001-143 - Rev 05
Status : Valid
Issue Date : 2021-06-29
Type : Chemical
Substance Number : 1243
Certificate Number : R1-CEP 2007-091 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2014-09-26
Type : Chemical
Substance Number : 1243
Certificate Number : R1-CEP 2001-270 - Rev 01
Status : Valid
Issue Date : 2009-06-12
Type : Chemical
Substance Number : 1243
A Mitoxantrone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitoxantrone, including repackagers and relabelers. The FDA regulates Mitoxantrone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitoxantrone 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 Mitoxantrone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitoxantrone supplier is an individual or a company that provides Mitoxantrone active pharmaceutical ingredient (API) or Mitoxantrone finished formulations upon request. The Mitoxantrone suppliers may include Mitoxantrone API manufacturers, exporters, distributors and traders.
click here to find a list of Mitoxantrone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mitoxantrone CEP of the European Pharmacopoeia monograph is often referred to as a Mitoxantrone Certificate of Suitability (COS). The purpose of a Mitoxantrone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mitoxantrone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mitoxantrone to their clients by showing that a Mitoxantrone CEP has been issued for it. The manufacturer submits a Mitoxantrone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mitoxantrone CEP holder for the record. Additionally, the data presented in the Mitoxantrone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mitoxantrone DMF.
A Mitoxantrone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mitoxantrone 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 Mitoxantrone suppliers with CEP (COS) on PharmaCompass.
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