01 1Roche Diagnostics GmbH Penzberg DE
01 1Galactose
01 1Germany
01 1Withdrawn by Holder
Certificate Number : R1-CEP 1997-098 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2010-12-01
Type : Chemical
Substance Number : 1215
A Alpha-D-Galactose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpha-D-Galactose, including repackagers and relabelers. The FDA regulates Alpha-D-Galactose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpha-D-Galactose API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Alpha-D-Galactose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alpha-D-Galactose supplier is an individual or a company that provides Alpha-D-Galactose active pharmaceutical ingredient (API) or Alpha-D-Galactose finished formulations upon request. The Alpha-D-Galactose suppliers may include Alpha-D-Galactose API manufacturers, exporters, distributors and traders.
click here to find a list of Alpha-D-Galactose suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alpha-D-Galactose CEP of the European Pharmacopoeia monograph is often referred to as a Alpha-D-Galactose Certificate of Suitability (COS). The purpose of a Alpha-D-Galactose CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alpha-D-Galactose EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alpha-D-Galactose to their clients by showing that a Alpha-D-Galactose CEP has been issued for it. The manufacturer submits a Alpha-D-Galactose CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alpha-D-Galactose CEP holder for the record. Additionally, the data presented in the Alpha-D-Galactose CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alpha-D-Galactose DMF.
A Alpha-D-Galactose CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alpha-D-Galactose 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 Alpha-D-Galactose suppliers with CEP (COS) on PharmaCompass.
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