01 2AARTI DRUGS LIMITED Mumbai IN
02 3AMOLI ORGANICS PRIVATE LIMITED Mumbai IN
03 1ARCH PHARMALABS LIMITED Mumbai IN
04 1Estechpharma Co., Ltd. Kyonggi-do KR
05 1HENAN DONGTAI PHARM CO., LTD. Anyang City CN
06 1Jiangxi Synergy Pharmaceutical Co., Ltd. Fengxin CN
01 7Aceclofenac
02 2Aceclofenac, Process-II
01 2China
02 6India
03 1South Korea
01 7Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
Certificate Number : R0-CEP 2022-180 - Rev 00
Status : Valid
Issue Date : 2022-09-01
Type : Chemical
Substance Number : 1281
Certificate Number : R1-CEP 2008-129 - Rev 01
Status : Valid
Issue Date : 2020-05-07
Type : Chemical
Substance Number : 1281
Certificate Number : R1-CEP 2014-100 - Rev 00
Status : Valid
Issue Date : 2021-02-10
Type : Chemical
Substance Number : 1281
Certificate Number : R0-CEP 2022-419 - Rev 00
Status : Valid
Issue Date : 2022-12-09
Type : Chemical
Substance Number : 1281
Certificate Number : R0-CEP 2006-050 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2009-10-14
Type : Chemical
Substance Number : 1281
Certificate Number : R1-CEP 2006-133 - Rev 01
Status : Valid
Issue Date : 2014-04-15
Type : Chemical
Substance Number : 1281
Certificate Number : R1-CEP 2004-006 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2010-04-23
Type : Chemical
Substance Number : 1281
Certificate Number : CEP 2023-072 - Rev 00
Status : Valid
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 1281
Certificate Number : R1-CEP 2013-274 - Rev 01
Status : Valid
Issue Date : 2021-07-20
Type : Chemical
Substance Number : 1281
A Biofenac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biofenac, including repackagers and relabelers. The FDA regulates Biofenac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biofenac 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 Biofenac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Biofenac supplier is an individual or a company that provides Biofenac active pharmaceutical ingredient (API) or Biofenac finished formulations upon request. The Biofenac suppliers may include Biofenac API manufacturers, exporters, distributors and traders.
click here to find a list of Biofenac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Biofenac CEP of the European Pharmacopoeia monograph is often referred to as a Biofenac Certificate of Suitability (COS). The purpose of a Biofenac CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Biofenac EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Biofenac to their clients by showing that a Biofenac CEP has been issued for it. The manufacturer submits a Biofenac CEP (COS) as part of the market authorization procedure, and it takes on the role of a Biofenac CEP holder for the record. Additionally, the data presented in the Biofenac CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Biofenac DMF.
A Biofenac CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Biofenac 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 Biofenac suppliers with CEP (COS) on PharmaCompass.
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