Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1Moehs Iberica
02 1Apex Healthcare
03 1Cambrex Corporation
04 1Delta Synthetic Co. Ltd
05 1Gufic Biosciences
06 1Harman Finochem
07 1Konduskar Laboratories
08 1Mahendra Chemicals
09 1SALSBURY CHEMICALS INC
10 1Swati Spentose
11 3Blank
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-05
Pay. Date : 2014-05-29
DMF Number : 5876
Submission : 1985-06-10
Status :
Type : II
98
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A LTA II KIT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LTA II KIT, including repackagers and relabelers. The FDA regulates LTA II KIT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LTA II KIT 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 LTA II KIT supplier is an individual or a company that provides LTA II KIT active pharmaceutical ingredient (API) or LTA II KIT finished formulations upon request. The LTA II KIT suppliers may include LTA II KIT API manufacturers, exporters, distributors and traders.
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A LTA II KIT DMF (Drug Master File) is a document detailing the whole manufacturing process of LTA II KIT active pharmaceutical ingredient (API) in detail. Different forms of LTA II KIT DMFs exist exist since differing nations have different regulations, such as LTA II KIT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LTA II KIT DMF submitted to regulatory agencies in the US is known as a USDMF. LTA II KIT USDMF includes data on LTA II KIT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LTA II KIT USDMF is kept confidential to protect the manufacturer’s intellectual property.
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