01 1Pharmacia & Upjohn Company Kalamazoo US
01 1Estramustine Phosphate Sodium
01 1U.S.A
01 1Withdrawn by Holder
Certificate Number : R0-CEP 2000-408 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2001-11-16
Type : TSE
Substance Number :
A Estramustine Phosphate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estramustine Phosphate Sodium, including repackagers and relabelers. The FDA regulates Estramustine Phosphate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium supplier is an individual or a company that provides Estramustine Phosphate Sodium active pharmaceutical ingredient (API) or Estramustine Phosphate Sodium finished formulations upon request. The Estramustine Phosphate Sodium suppliers may include Estramustine Phosphate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Estramustine Phosphate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estramustine Phosphate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Estramustine Phosphate Sodium Certificate of Suitability (COS). The purpose of a Estramustine Phosphate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Estramustine Phosphate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Estramustine Phosphate Sodium to their clients by showing that a Estramustine Phosphate Sodium CEP has been issued for it. The manufacturer submits a Estramustine Phosphate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Estramustine Phosphate Sodium CEP holder for the record. Additionally, the data presented in the Estramustine Phosphate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Estramustine Phosphate Sodium DMF.
A Estramustine Phosphate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium suppliers with CEP (COS) on PharmaCompass.
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