01 1FIRST RARE MATERIALS CO LTD
02 1Laboratorios Imperiales, S.A. de C.V.
03 1OMICRON QUIMICA SA
01 3BISMUTH SUBNITRATE
01 1China
02 1France
03 1Mexico
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27870
Submission : 2013-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25895
Submission : 2012-03-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14197
Submission : 1999-04-14
Status : Inactive
Type : II
A Bismuth Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth Nitrate, including repackagers and relabelers. The FDA regulates Bismuth Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth 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 Bismuth Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bismuth Nitrate supplier is an individual or a company that provides Bismuth Nitrate active pharmaceutical ingredient (API) or Bismuth Nitrate finished formulations upon request. The Bismuth Nitrate suppliers may include Bismuth Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Bismuth Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bismuth Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bismuth Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Bismuth Nitrate DMFs exist exist since differing nations have different regulations, such as Bismuth Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bismuth Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Bismuth Nitrate USDMF includes data on Bismuth Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bismuth Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bismuth Nitrate suppliers with USDMF on PharmaCompass.
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