01 1Alkaloida Chemical Company Zrt
02 1F. Hoffmann-La Roche
03 1Harman Finochem
04 1Nantong Jinghua Pharmaceutical
05 1Shandong Xinhua Pharmaceutical
06 2Siegfried AG
07 2Blank
01 1HYOSCYAMINE SO4 & HYOSCYAMINE S04 W/PHENOBARBITAL SR CAPS-KREMERS
02 1PENTOBARBITOL SODIUM USP
03 2PHENOBARBITAL
04 1PHENOBARBITAL SODIUM USP
05 1PHENOBARBITAL TIMED RELEASE PELLETS
06 2PHENOBARBITAL USP
07 1SYNTHESIS OF PHENOBARBITAL, BULK FORM
01 2China
02 1Hungary
03 1India
04 3Switzerland
05 2Blank
01 6Active
02 3Inactive
01 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4642
Submission : 1982-09-01
Status : Active
Type : II
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 : 4714
Submission : 1982-11-10
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 : 1003
Submission : 1966-10-19
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
58
PharmaCompass offers a list of Phenobarbital 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 Phenobarbital manufacturer or Phenobarbital supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenobarbital manufacturer or Phenobarbital supplier.
PharmaCompass also assists you with knowing the Phenobarbital API Price utilized in the formulation of products. Phenobarbital API Price is not always fixed or binding as the Phenobarbital Price is obtained through a variety of data sources. The Phenobarbital Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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