01 1Jost Chemical
02 1Mallinckrodt Pharmaceuticals
03 1PHIBRO ANIMAL HEALTH CORPORATION
04 1Productos Quimicos Naturales
05 2Blank
01 2POTASSIUM NITRATE
02 1POTASSIUM NITRATE TAC
03 2POTASSIUM NITRATE USP
04 1POTASSIUM NITRATE USP GRADE
01 1Ireland
02 1Mexico
03 2U.S.A
04 2Blank
01 6Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23359
Submission : 2009-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4034
Submission : 1981-01-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14252
Submission : 1999-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23777
Submission : 2010-04-29
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12357
Submission : 1997-02-11
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8183
Submission : 1989-08-24
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Potassium Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Nitrate, including repackagers and relabelers. The FDA regulates Potassium Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Nitrate 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 Potassium Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Nitrate supplier is an individual or a company that provides Potassium Nitrate active pharmaceutical ingredient (API) or Potassium Nitrate finished formulations upon request. The Potassium Nitrate suppliers may include Potassium Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Potassium Nitrate DMFs exist exist since differing nations have different regulations, such as Potassium Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Nitrate USDMF includes data on Potassium Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium Nitrate suppliers with USDMF on PharmaCompass.
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