01 1Amphastar Pharmaceuticals
01 1SODIUM NITRITE INJECTION USP, 30 MG / ML, 10 ML
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19016
Submission : 2005-12-06
Status : Inactive
Type : II
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A Filmerine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Filmerine, including repackagers and relabelers. The FDA regulates Filmerine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Filmerine 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 Filmerine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Filmerine supplier is an individual or a company that provides Filmerine active pharmaceutical ingredient (API) or Filmerine finished formulations upon request. The Filmerine suppliers may include Filmerine API manufacturers, exporters, distributors and traders.
click here to find a list of Filmerine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Filmerine DMF (Drug Master File) is a document detailing the whole manufacturing process of Filmerine active pharmaceutical ingredient (API) in detail. Different forms of Filmerine DMFs exist exist since differing nations have different regulations, such as Filmerine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Filmerine DMF submitted to regulatory agencies in the US is known as a USDMF. Filmerine USDMF includes data on Filmerine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Filmerine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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