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