01 1Croda Chemicals Europe Ltd Leek GB
02 1EPAX NORWAY AS Aalesund NO
01 1Omega-3-acid triglycerides
02 1Omega-3-acid triglycerides, Grade RF 07300
01 1Norway
02 1United Kingdom
01 1Valid
02 1Withdrawn by Holder
Omega-3-acid Triglycerides, Grade RF 07300
Certificate Number : R1-CEP 2000-233 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2007-10-24
Type : Chemical
Substance Number : 1352
Certificate Number : R1-CEP 2005-213 - Rev 01
Status : Valid
Issue Date : 2012-05-14
Type : Chemical
Substance Number : 1352
A Tripalmitolein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tripalmitolein, including repackagers and relabelers. The FDA regulates Tripalmitolein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tripalmitolein 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 Tripalmitolein supplier is an individual or a company that provides Tripalmitolein active pharmaceutical ingredient (API) or Tripalmitolein finished formulations upon request. The Tripalmitolein suppliers may include Tripalmitolein API manufacturers, exporters, distributors and traders.
click here to find a list of Tripalmitolein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tripalmitolein CEP of the European Pharmacopoeia monograph is often referred to as a Tripalmitolein Certificate of Suitability (COS). The purpose of a Tripalmitolein CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tripalmitolein EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tripalmitolein to their clients by showing that a Tripalmitolein CEP has been issued for it. The manufacturer submits a Tripalmitolein CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tripalmitolein CEP holder for the record. Additionally, the data presented in the Tripalmitolein CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tripalmitolein DMF.
A Tripalmitolein CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tripalmitolein 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 Tripalmitolein suppliers with CEP (COS) on PharmaCompass.
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