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