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 : 9660
Submission : 1992-04-20
Status : Active
Type : II
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 : 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 Pepto-bismol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pepto-bismol, including repackagers and relabelers. The FDA regulates Pepto-bismol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pepto-bismol 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 Pepto-bismol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pepto-bismol supplier is an individual or a company that provides Pepto-bismol active pharmaceutical ingredient (API) or Pepto-bismol finished formulations upon request. The Pepto-bismol suppliers may include Pepto-bismol API manufacturers, exporters, distributors and traders.
click here to find a list of Pepto-bismol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pepto-bismol DMF (Drug Master File) is a document detailing the whole manufacturing process of Pepto-bismol active pharmaceutical ingredient (API) in detail. Different forms of Pepto-bismol DMFs exist exist since differing nations have different regulations, such as Pepto-bismol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pepto-bismol DMF submitted to regulatory agencies in the US is known as a USDMF. Pepto-bismol USDMF includes data on Pepto-bismol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pepto-bismol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pepto-bismol suppliers with USDMF on PharmaCompass.
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