Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1Moehs Iberica
02 1Alivus Life Sciences
03 1CordenPharma
04 1Harman Finochem
05 1Laboratorio Chimico Internazionale Spa
06 1Lupin Ltd
07 1Olon S.p.A
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-30
Pay. Date : 2014-10-09
DMF Number : 24540
Submission : 2011-01-07
Status :
Type : II
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A TRILIPIX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRILIPIX, including repackagers and relabelers. The FDA regulates TRILIPIX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRILIPIX API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A TRILIPIX supplier is an individual or a company that provides TRILIPIX active pharmaceutical ingredient (API) or TRILIPIX finished formulations upon request. The TRILIPIX suppliers may include TRILIPIX API manufacturers, exporters, distributors and traders.
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A TRILIPIX DMF (Drug Master File) is a document detailing the whole manufacturing process of TRILIPIX active pharmaceutical ingredient (API) in detail. Different forms of TRILIPIX DMFs exist exist since differing nations have different regulations, such as TRILIPIX USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TRILIPIX DMF submitted to regulatory agencies in the US is known as a USDMF. TRILIPIX USDMF includes data on TRILIPIX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TRILIPIX USDMF is kept confidential to protect the manufacturer’s intellectual property.
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