01 1OMICRON QUIMICA SA
01 1BISMUTH SUBGALLATE
01 1France
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14196
Submission : 1999-04-15
Status : Inactive
Type : II
A Bismuth Subgallate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth Subgallate, including repackagers and relabelers. The FDA regulates Bismuth Subgallate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth Subgallate 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 Subgallate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bismuth Subgallate supplier is an individual or a company that provides Bismuth Subgallate active pharmaceutical ingredient (API) or Bismuth Subgallate finished formulations upon request. The Bismuth Subgallate suppliers may include Bismuth Subgallate API manufacturers, exporters, distributors and traders.
click here to find a list of Bismuth Subgallate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bismuth Subgallate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bismuth Subgallate active pharmaceutical ingredient (API) in detail. Different forms of Bismuth Subgallate DMFs exist exist since differing nations have different regulations, such as Bismuth Subgallate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bismuth Subgallate DMF submitted to regulatory agencies in the US is known as a USDMF. Bismuth Subgallate USDMF includes data on Bismuth Subgallate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bismuth Subgallate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bismuth Subgallate suppliers with USDMF on PharmaCompass.
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