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01 1DUPONT NUTRITION BIOSCIENCES APS Copenhagen K DK
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01 1Lactitol Monohydrate
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01 1Denmark
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01 1Valid
Certificate Number : R1-CEP 2011-255 - Rev 00
Status : Valid
Issue Date : 2017-09-28
Type : Chemical
Substance Number : 1337
A Lactitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactitol, including repackagers and relabelers. The FDA regulates Lactitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactitol 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 Lactitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lactitol supplier is an individual or a company that provides Lactitol active pharmaceutical ingredient (API) or Lactitol finished formulations upon request. The Lactitol suppliers may include Lactitol API manufacturers, exporters, distributors and traders.
click here to find a list of Lactitol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lactitol CEP of the European Pharmacopoeia monograph is often referred to as a Lactitol Certificate of Suitability (COS). The purpose of a Lactitol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lactitol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lactitol to their clients by showing that a Lactitol CEP has been issued for it. The manufacturer submits a Lactitol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lactitol CEP holder for the record. Additionally, the data presented in the Lactitol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lactitol DMF.
A Lactitol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lactitol 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 Lactitol suppliers with CEP (COS) on PharmaCompass.
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