01 1Alkaloida Chemical Company Zrt
02 1DMFs Not Supported
03 1F. Hoffmann-La Roche
04 1Harman Finochem
05 1Nantong Jinghua Pharmaceutical
06 1Shandong Xinhua Pharmaceutical
07 2Siegfried AG
08 2Blank
01 1CALCIUM PHENOBARBITAL
02 1HYOSCYAMINE SO4 & HYOSCYAMINE S04 W/PHENOBARBITAL SR CAPS-KREMERS
03 1PENTOBARBITOL SODIUM USP
04 2PHENOBARBITAL
05 1PHENOBARBITAL SODIUM USP
06 1PHENOBARBITAL TIMED RELEASE PELLETS
07 2PHENOBARBITAL USP
08 1SYNTHESIS OF PHENOBARBITAL, BULK FORM
01 2China
02 1Hungary
03 1India
04 3Switzerland
05 3Blank
01 6Active
02 4Inactive
01 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4642
Submission : 1982-09-01
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 778
Submission : 1964-01-24
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3756
Submission : 1980-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17823
Submission : 2004-11-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31321
Submission : 2017-02-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27827
Submission : 2013-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1169
Submission : 1968-04-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1049
Submission : 1967-03-21
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1003
Submission : 1966-10-19
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 : 4714
Submission : 1982-11-10
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Phenobarbital manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenobarbital, including repackagers and relabelers. The FDA regulates Phenobarbital manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenobarbital 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 Phenobarbital manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenobarbital supplier is an individual or a company that provides Phenobarbital active pharmaceutical ingredient (API) or Phenobarbital finished formulations upon request. The Phenobarbital suppliers may include Phenobarbital API manufacturers, exporters, distributors and traders.
click here to find a list of Phenobarbital suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenobarbital DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenobarbital active pharmaceutical ingredient (API) in detail. Different forms of Phenobarbital DMFs exist exist since differing nations have different regulations, such as Phenobarbital USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenobarbital DMF submitted to regulatory agencies in the US is known as a USDMF. Phenobarbital USDMF includes data on Phenobarbital's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenobarbital USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenobarbital suppliers with USDMF on PharmaCompass.
We have 6 companies offering Phenobarbital
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
