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01 1Boehringer Ingelheim GmbH
02 1Vital Laboratories Private Limited
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01 1SCOPOLAMINE BUTYL BROMIDE (HYOSCINE BUTYL BROMIDE)
02 1SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPAN)
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01 1Germany
02 1India
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01 2Inactive
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01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11679
Submission : 1995-09-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24477
Submission : 2010-10-01
Status : Inactive
Type : II
A Butylscopolamine Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butylscopolamine Bromide, including repackagers and relabelers. The FDA regulates Butylscopolamine Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butylscopolamine Bromide 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 Butylscopolamine Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Butylscopolamine Bromide supplier is an individual or a company that provides Butylscopolamine Bromide active pharmaceutical ingredient (API) or Butylscopolamine Bromide finished formulations upon request. The Butylscopolamine Bromide suppliers may include Butylscopolamine Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Butylscopolamine Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Butylscopolamine Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Butylscopolamine Bromide active pharmaceutical ingredient (API) in detail. Different forms of Butylscopolamine Bromide DMFs exist exist since differing nations have different regulations, such as Butylscopolamine Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butylscopolamine Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Butylscopolamine Bromide USDMF includes data on Butylscopolamine Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butylscopolamine Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butylscopolamine Bromide suppliers with USDMF on PharmaCompass.
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