01 35N Plus Lubeck GmbH
02 1FIRST RARE MATERIALS CO LTD
03 1Laboratorios Imperiales, S.A. de C.V.
04 1OMICRON QUIMICA SA
05 1Siegfried AG
01 4BISMUTH SUBSALICYLATE
02 1BISMUTH SUBSALICYLATE PASTE
03 1BISMUTH SUBSALICYLATE SG
04 1BISMUTH SUBSALICYLATE SG FINE
01 3Canada
02 1China
03 1France
04 1Mexico
05 1Switzerland
01 5Active
02 2Inactive
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36384
Submission : 2021-12-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16327
Submission : 2002-12-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9660
Submission : 1992-04-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27871
Submission : 2013-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25360
Submission : 2011-10-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11889
Submission : 1996-03-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 572
Submission : 1963-05-29
Status : Inactive
Type : II
A Bismuth Subsalicylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth Subsalicylate, including repackagers and relabelers. The FDA regulates Bismuth Subsalicylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth Subsalicylate 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 Subsalicylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bismuth Subsalicylate supplier is an individual or a company that provides Bismuth Subsalicylate active pharmaceutical ingredient (API) or Bismuth Subsalicylate finished formulations upon request. The Bismuth Subsalicylate suppliers may include Bismuth Subsalicylate API manufacturers, exporters, distributors and traders.
click here to find a list of Bismuth Subsalicylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bismuth Subsalicylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bismuth Subsalicylate active pharmaceutical ingredient (API) in detail. Different forms of Bismuth Subsalicylate DMFs exist exist since differing nations have different regulations, such as Bismuth Subsalicylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bismuth Subsalicylate DMF submitted to regulatory agencies in the US is known as a USDMF. Bismuth Subsalicylate USDMF includes data on Bismuth Subsalicylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bismuth Subsalicylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bismuth Subsalicylate suppliers with USDMF on PharmaCompass.
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