01 3Pharmacia & Upjohn Company Kalamazoo US
01 1Triamcinolone
02 1Triamcinolone 3, (21-(acetyloxy)pregna-1,4,9(11)-16-tetraene-3,20-dione)
03 1Triamcinolone 5, (9beta,11beta-Epoxy-16alpha,17alpha,21-trihydroxypregna-1,4-diene-3,20-dione)
01 3U.S.A
01 2Expired
02 1Withdrawn by Holder
Triamcinolone 5, (9beta,11beta-Epoxy-16alpha,17a...
Certificate Number : R0-CEP 2001-127 - Rev 00
Status : Expired
Issue Date : 2002-04-09
Type : TSE
Substance Number :
Triamcinolone 3, (21-(acetyloxy)pregna-1,4,9(11)...
Certificate Number : R0-CEP 2001-230 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2002-04-09
Type : TSE
Substance Number :
Certificate Number : R0-CEP 2001-129 - Rev 00
Status : Expired
Issue Date : 2002-05-17
Type : TSE
Substance Number : 1376
11
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A Tricortone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tricortone, including repackagers and relabelers. The FDA regulates Tricortone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tricortone 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 Tricortone supplier is an individual or a company that provides Tricortone active pharmaceutical ingredient (API) or Tricortone finished formulations upon request. The Tricortone suppliers may include Tricortone API manufacturers, exporters, distributors and traders.
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A Tricortone CEP of the European Pharmacopoeia monograph is often referred to as a Tricortone Certificate of Suitability (COS). The purpose of a Tricortone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tricortone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tricortone to their clients by showing that a Tricortone CEP has been issued for it. The manufacturer submits a Tricortone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tricortone CEP holder for the record. Additionally, the data presented in the Tricortone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tricortone DMF.
A Tricortone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tricortone 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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