01 1Pharmacia & Upjohn Company Kalamazoo US
01 1Tirilazad
01 1U.S.A
01 1Expired
Certificate Number : R0-CEP 2000-355 - Rev 00
Status : Expired
Issue Date : 2002-08-02
Type : TSE
Substance Number : 2243
A Tirilazad manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tirilazad, including repackagers and relabelers. The FDA regulates Tirilazad manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tirilazad 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 Tirilazad supplier is an individual or a company that provides Tirilazad active pharmaceutical ingredient (API) or Tirilazad finished formulations upon request. The Tirilazad suppliers may include Tirilazad API manufacturers, exporters, distributors and traders.
click here to find a list of Tirilazad suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tirilazad CEP of the European Pharmacopoeia monograph is often referred to as a Tirilazad Certificate of Suitability (COS). The purpose of a Tirilazad CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tirilazad EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tirilazad to their clients by showing that a Tirilazad CEP has been issued for it. The manufacturer submits a Tirilazad CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tirilazad CEP holder for the record. Additionally, the data presented in the Tirilazad CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tirilazad DMF.
A Tirilazad CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tirilazad 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 Tirilazad suppliers with CEP (COS) on PharmaCompass.
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