01 1CordenPharma
01 1OMIGANAN PENTAHYDROCHLORIDE BULK DRUG SUBSTANCE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21323
Submission : 2008-02-07
Status : Inactive
Type : II
A Omiganan Pentahydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omiganan Pentahydrochloride, including repackagers and relabelers. The FDA regulates Omiganan Pentahydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omiganan Pentahydrochloride 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 Omiganan Pentahydrochloride supplier is an individual or a company that provides Omiganan Pentahydrochloride active pharmaceutical ingredient (API) or Omiganan Pentahydrochloride finished formulations upon request. The Omiganan Pentahydrochloride suppliers may include Omiganan Pentahydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Omiganan Pentahydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Omiganan Pentahydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Omiganan Pentahydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Omiganan Pentahydrochloride DMFs exist exist since differing nations have different regulations, such as Omiganan Pentahydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Omiganan Pentahydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Omiganan Pentahydrochloride USDMF includes data on Omiganan Pentahydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Omiganan Pentahydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Omiganan Pentahydrochloride suppliers with USDMF on PharmaCompass.
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