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