01 1Diosynth BV Oss NL
01 1Orgotein
01 1United Kingdom
01 1Expired
Certificate Number : R0-CEP 2001-124 - Rev 01
Status : Expired
Issue Date : 2005-02-28
Type : TSE
Substance Number :
A Orgotein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orgotein, including repackagers and relabelers. The FDA regulates Orgotein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orgotein 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 Orgotein supplier is an individual or a company that provides Orgotein active pharmaceutical ingredient (API) or Orgotein finished formulations upon request. The Orgotein suppliers may include Orgotein API manufacturers, exporters, distributors and traders.
click here to find a list of Orgotein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Orgotein CEP of the European Pharmacopoeia monograph is often referred to as a Orgotein Certificate of Suitability (COS). The purpose of a Orgotein CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orgotein EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orgotein to their clients by showing that a Orgotein CEP has been issued for it. The manufacturer submits a Orgotein CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orgotein CEP holder for the record. Additionally, the data presented in the Orgotein CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orgotein DMF.
A Orgotein CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orgotein 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 Orgotein suppliers with CEP (COS) on PharmaCompass.
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