01 1Pharmacia & Upjohn Company Kalamazoo US
01 13-oxo-4-azaandrost-5-ene-17beta-carboxylic acid, Delta-5-4-Aza-Acid
01 1U.S.A
01 1Withdrawn by Holder
3-oxo-4-azaandrost-5-ene-17beta-carboxylic Acid,...
Certificate Number : R0-CEP 2000-292 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2001-12-12
Type : TSE
Substance Number :
A Carboxylic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carboxylic Acid, including repackagers and relabelers. The FDA regulates Carboxylic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carboxylic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Carboxylic Acid supplier is an individual or a company that provides Carboxylic Acid active pharmaceutical ingredient (API) or Carboxylic Acid finished formulations upon request. The Carboxylic Acid suppliers may include Carboxylic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Carboxylic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carboxylic Acid CEP of the European Pharmacopoeia monograph is often referred to as a Carboxylic Acid Certificate of Suitability (COS). The purpose of a Carboxylic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Carboxylic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Carboxylic Acid to their clients by showing that a Carboxylic Acid CEP has been issued for it. The manufacturer submits a Carboxylic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Carboxylic Acid CEP holder for the record. Additionally, the data presented in the Carboxylic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Carboxylic Acid DMF.
A Carboxylic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Carboxylic Acid 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 Carboxylic Acid suppliers with CEP (COS) on PharmaCompass.
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