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