01 1The Mosaic Company
02 1Blank
01 1ERYTHRITOL TETRANITRATE(ETN) MNFG IN SPANISH FORK, UTAH FACILITIES
02 1NITROGLYCERIN,PENTAERYTHRITOL TETRANITRATE AND ISOSORBIDE DINITRATE
01 1U.S.A
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4143
Submission : 1981-04-13
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4504
Submission : 1982-03-18
Status : Inactive
Type : II
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A Erythrityl Tetranitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erythrityl Tetranitrate, including repackagers and relabelers. The FDA regulates Erythrityl Tetranitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erythrityl Tetranitrate 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 Erythrityl Tetranitrate supplier is an individual or a company that provides Erythrityl Tetranitrate active pharmaceutical ingredient (API) or Erythrityl Tetranitrate finished formulations upon request. The Erythrityl Tetranitrate suppliers may include Erythrityl Tetranitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Erythrityl Tetranitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Erythrityl Tetranitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Erythrityl Tetranitrate active pharmaceutical ingredient (API) in detail. Different forms of Erythrityl Tetranitrate DMFs exist exist since differing nations have different regulations, such as Erythrityl Tetranitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Erythrityl Tetranitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Erythrityl Tetranitrate USDMF includes data on Erythrityl Tetranitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Erythrityl Tetranitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Erythrityl Tetranitrate suppliers with USDMF on PharmaCompass.
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