01 1HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE
02 1MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN
03 1MYLAN LABORATORIES LIMITED Hyderabad IN
04 1SUZHOU LIXIN PHARMACEUTICAL CO., LTD. Suzhou CN
05 1VUAB PHARMA A.S. Roztoky CZ
01 5Dacarbazine
01 1China
02 1Czech Republic
03 1Germany
04 1India
05 1U.S.A
01 3Valid
02 2Withdrawn by Holder
Certificate Number : CEP 2008-036 - Rev 03
Status : Valid
Issue Date : 2023-10-02
Type : Chemical
Substance Number : 1691
Certificate Number : R1-CEP 2012-066 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2018-02-07
Type : Chemical
Substance Number : 1691
Certificate Number : R1-CEP 2010-315 - Rev 02
Status : Valid
Issue Date : 2023-02-17
Type : Chemical
Substance Number : 1691
Certificate Number : R0-CEP 2016-082 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2019-12-18
Type : Chemical
Substance Number : 1691
Certificate Number : R1-CEP 2012-330 - Rev 02
Status : Valid
Issue Date : 2023-05-26
Type : Chemical
Substance Number : 1691
A Dacarbazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dacarbazine, including repackagers and relabelers. The FDA regulates Dacarbazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dacarbazine 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 Dacarbazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dacarbazine supplier is an individual or a company that provides Dacarbazine active pharmaceutical ingredient (API) or Dacarbazine finished formulations upon request. The Dacarbazine suppliers may include Dacarbazine API manufacturers, exporters, distributors and traders.
click here to find a list of Dacarbazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dacarbazine CEP of the European Pharmacopoeia monograph is often referred to as a Dacarbazine Certificate of Suitability (COS). The purpose of a Dacarbazine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dacarbazine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dacarbazine to their clients by showing that a Dacarbazine CEP has been issued for it. The manufacturer submits a Dacarbazine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dacarbazine CEP holder for the record. Additionally, the data presented in the Dacarbazine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dacarbazine DMF.
A Dacarbazine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dacarbazine 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 Dacarbazine suppliers with CEP (COS) on PharmaCompass.
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