01 1Chattem Chemicals, Inc
02 1DMFs Not Supported
03 1Mallinckrodt Pharmaceuticals
04 1Siegfried AG
01 1DIDRATE (DIHYDROCODEINE BITARTRATE ANHYDROUS )
02 1DIHYDROCODEINE BITARTRATE ANHYDROUS
03 1DIHYDROCODEINE BITARTRATE USP
04 1PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE)
01 1Ireland
02 1Switzerland
03 1U.S.A
04 1Blank
01 2Active
02 2Inactive
01 1Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32354
Submission : 2019-09-27
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 207
Submission : 1956-05-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-24
Pay. Date : 2012-12-04
DMF Number : 191
Submission : 1956-01-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6009
Submission : 1985-09-27
Status : Inactive
Type : II
A Dihidrocodeina manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dihidrocodeina, including repackagers and relabelers. The FDA regulates Dihidrocodeina manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dihidrocodeina 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 Dihidrocodeina manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dihidrocodeina supplier is an individual or a company that provides Dihidrocodeina active pharmaceutical ingredient (API) or Dihidrocodeina finished formulations upon request. The Dihidrocodeina suppliers may include Dihidrocodeina API manufacturers, exporters, distributors and traders.
click here to find a list of Dihidrocodeina suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dihidrocodeina DMF (Drug Master File) is a document detailing the whole manufacturing process of Dihidrocodeina active pharmaceutical ingredient (API) in detail. Different forms of Dihidrocodeina DMFs exist exist since differing nations have different regulations, such as Dihidrocodeina USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dihidrocodeina DMF submitted to regulatory agencies in the US is known as a USDMF. Dihidrocodeina USDMF includes data on Dihidrocodeina's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dihidrocodeina USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dihidrocodeina suppliers with USDMF on PharmaCompass.
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