01 1FDC Limited Mumbai IN
02 1JANSSEN PHARMACEUTICA NV Beerse BE
03 1Janssen Pharmaceutical Ltd County Cork IE
04 1OLON S.P.A. Rodano IT
05 1QUIMICA SINTETICA S.A. Alcala De Henares ES
01 4Miconazole nitrate
02 1Miconazole nitrate, Micronised
01 1India
02 1Italy
03 1Spain
04 2U.S.A
01 4Valid
02 1Withdrawn by Holder
Certificate Number : CEP 1998-146 - Rev 04
Status : Valid
Issue Date : 2024-08-19
Type : Chemical
Substance Number : 513
Certificate Number : R2-CEP 1995-008 - Rev 04
Status : Valid
Issue Date : 2023-03-01
Type : Chemical
Substance Number : 513
Certificate Number : R0-CEP 1998-153 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2001-12-18
Type : Chemical
Substance Number : 513
Certificate Number : R1-CEP 2002-100 - Rev 09
Status : Valid
Issue Date : 2022-05-23
Type : Chemical
Substance Number : 513
Miconazole Nitrate, Micronised
Certificate Number : R0-CEP 2020-052 - Rev 00
Status : Valid
Issue Date : 2021-08-10
Type : Chemical
Substance Number : 513
A Brentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brentan, including repackagers and relabelers. The FDA regulates Brentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brentan 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 Brentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brentan supplier is an individual or a company that provides Brentan active pharmaceutical ingredient (API) or Brentan finished formulations upon request. The Brentan suppliers may include Brentan API manufacturers, exporters, distributors and traders.
click here to find a list of Brentan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Brentan CEP of the European Pharmacopoeia monograph is often referred to as a Brentan Certificate of Suitability (COS). The purpose of a Brentan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Brentan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Brentan to their clients by showing that a Brentan CEP has been issued for it. The manufacturer submits a Brentan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Brentan CEP holder for the record. Additionally, the data presented in the Brentan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Brentan DMF.
A Brentan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Brentan 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 Brentan suppliers with CEP (COS) on PharmaCompass.
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