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