01 1NANTONG JINGHUA PHARMACEUTICAL CO., LTD. Nantong CN
02 1REINE LIFESCIENCE Ankleshwar IN
01 2Phenylbutazone
01 1China
02 1India
01 2Valid
Certificate Number : R1-CEP 2004-244 - Rev 03
Status : Valid
Issue Date : 2016-11-24
Type : Chemical
Substance Number : 422
Certificate Number : R0-CEP 2019-267 - Rev 00
Status : Valid
Issue Date : 2021-12-08
Type : Chemical
Substance Number : 422
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A Buta phen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Buta phen, including repackagers and relabelers. The FDA regulates Buta phen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Buta phen API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Buta phen supplier is an individual or a company that provides Buta phen active pharmaceutical ingredient (API) or Buta phen finished formulations upon request. The Buta phen suppliers may include Buta phen API manufacturers, exporters, distributors and traders.
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A Buta phen CEP of the European Pharmacopoeia monograph is often referred to as a Buta phen Certificate of Suitability (COS). The purpose of a Buta phen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Buta phen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Buta phen to their clients by showing that a Buta phen CEP has been issued for it. The manufacturer submits a Buta phen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Buta phen CEP holder for the record. Additionally, the data presented in the Buta phen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Buta phen DMF.
A Buta phen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Buta phen CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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