01 15N Plus Lubeck GmbH
02 1FIRST RARE MATERIALS CO LTD
01 2BISMUTH CITRATE
01 1Canada
02 1China
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9489
Submission : 1992-01-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27868
Submission : 2013-12-19
Status : Active
Type : II
A Bismuth Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth Citrate, including repackagers and relabelers. The FDA regulates Bismuth Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth Citrate 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 Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bismuth Citrate supplier is an individual or a company that provides Bismuth Citrate active pharmaceutical ingredient (API) or Bismuth Citrate finished formulations upon request. The Bismuth Citrate suppliers may include Bismuth Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Bismuth Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bismuth Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bismuth Citrate active pharmaceutical ingredient (API) in detail. Different forms of Bismuth Citrate DMFs exist exist since differing nations have different regulations, such as Bismuth Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bismuth Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Bismuth Citrate USDMF includes data on Bismuth Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bismuth Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bismuth Citrate suppliers with USDMF on PharmaCompass.
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