01 1Abbott Laboratories
02 1Chattem Chemicals, Inc
03 1Curia
04 1International Flavors and Fragrances
05 2Blank
01 2BUTABARBITAL
02 2BUTABARBITAL SODIUM
03 1BUTABARBITAL SODIUM, USP
04 1SODIUM BUTABARBITAL
01 4U.S.A
02 2Blank
01 2Active
02 4Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4872
Submission : 1983-03-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14438
Submission : 1999-10-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14636
Submission : 1999-12-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4366
Submission : 1981-11-25
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6490
Submission : 1986-06-17
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1048
Submission : 1967-03-24
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
23
PharmaCompass offers a list of Butabarbital API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Butabarbital manufacturer or Butabarbital supplier for your needs.
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A Butabarbital manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butabarbital, including repackagers and relabelers. The FDA regulates Butabarbital manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butabarbital API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Butabarbital supplier is an individual or a company that provides Butabarbital active pharmaceutical ingredient (API) or Butabarbital finished formulations upon request. The Butabarbital suppliers may include Butabarbital API manufacturers, exporters, distributors and traders.
click here to find a list of Butabarbital suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Butabarbital DMF (Drug Master File) is a document detailing the whole manufacturing process of Butabarbital active pharmaceutical ingredient (API) in detail. Different forms of Butabarbital DMFs exist exist since differing nations have different regulations, such as Butabarbital USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butabarbital DMF submitted to regulatory agencies in the US is known as a USDMF. Butabarbital USDMF includes data on Butabarbital's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butabarbital USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butabarbital suppliers with USDMF on PharmaCompass.
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