01 1FIRST RARE MATERIALS CO LTD
02 1OMICRON QUIMICA SA
01 2BISMUTH SUBCARBONATE
01 1China
02 1France
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27869
Submission : 2013-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12725
Submission : 1997-10-29
Status : Inactive
Type : II
A Bismuth Subcarbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth Subcarbonate, including repackagers and relabelers. The FDA regulates Bismuth Subcarbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth Subcarbonate 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 Subcarbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bismuth Subcarbonate supplier is an individual or a company that provides Bismuth Subcarbonate active pharmaceutical ingredient (API) or Bismuth Subcarbonate finished formulations upon request. The Bismuth Subcarbonate suppliers may include Bismuth Subcarbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Bismuth Subcarbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bismuth Subcarbonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bismuth Subcarbonate active pharmaceutical ingredient (API) in detail. Different forms of Bismuth Subcarbonate DMFs exist exist since differing nations have different regulations, such as Bismuth Subcarbonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bismuth Subcarbonate DMF submitted to regulatory agencies in the US is known as a USDMF. Bismuth Subcarbonate USDMF includes data on Bismuth Subcarbonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bismuth Subcarbonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bismuth Subcarbonate suppliers with USDMF on PharmaCompass.
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