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 Erinitrit manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erinitrit, including repackagers and relabelers. The FDA regulates Erinitrit manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erinitrit 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 Erinitrit manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Erinitrit supplier is an individual or a company that provides Erinitrit active pharmaceutical ingredient (API) or Erinitrit finished formulations upon request. The Erinitrit suppliers may include Erinitrit API manufacturers, exporters, distributors and traders.
click here to find a list of Erinitrit suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Erinitrit DMF (Drug Master File) is a document detailing the whole manufacturing process of Erinitrit active pharmaceutical ingredient (API) in detail. Different forms of Erinitrit DMFs exist exist since differing nations have different regulations, such as Erinitrit USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Erinitrit DMF submitted to regulatory agencies in the US is known as a USDMF. Erinitrit USDMF includes data on Erinitrit's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Erinitrit USDMF is kept confidential to protect the manufacturer’s intellectual property.
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