01 1Roche Diagnostics GmbH Mannheim DE
01 1Digitoxin
01 1Germany
01 1Withdrawn by Holder
Certificate Number : R1-CEP 1997-085 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2005-06-23
Type : Chemical
Substance Number : 78
A Digitoxin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Digitoxin, including repackagers and relabelers. The FDA regulates Digitoxin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Digitoxin 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 Digitoxin supplier is an individual or a company that provides Digitoxin active pharmaceutical ingredient (API) or Digitoxin finished formulations upon request. The Digitoxin suppliers may include Digitoxin API manufacturers, exporters, distributors and traders.
click here to find a list of Digitoxin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Digitoxin CEP of the European Pharmacopoeia monograph is often referred to as a Digitoxin Certificate of Suitability (COS). The purpose of a Digitoxin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Digitoxin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Digitoxin to their clients by showing that a Digitoxin CEP has been issued for it. The manufacturer submits a Digitoxin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Digitoxin CEP holder for the record. Additionally, the data presented in the Digitoxin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Digitoxin DMF.
A Digitoxin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Digitoxin 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 Digitoxin suppliers with CEP (COS) on PharmaCompass.
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