01 1Siegfried AG
02 2Tris Pharma Inc
01 1COD-CPM ER ORAL SUSPENSION
02 1COD-CPM-PSE ER ORAL SUSPENSION
03 1CODEINE
01 1Switzerland
02 2U.S.A
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9366
Submission : 1991-10-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27314
Submission : 2013-07-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29687
Submission : 2015-11-03
Status : Active
Type : II
A Codeine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Codeine, including repackagers and relabelers. The FDA regulates Codeine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Codeine 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 Codeine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Codeine supplier is an individual or a company that provides Codeine active pharmaceutical ingredient (API) or Codeine finished formulations upon request. The Codeine suppliers may include Codeine API manufacturers, exporters, distributors and traders.
click here to find a list of Codeine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Codeine DMF (Drug Master File) is a document detailing the whole manufacturing process of Codeine active pharmaceutical ingredient (API) in detail. Different forms of Codeine DMFs exist exist since differing nations have different regulations, such as Codeine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Codeine DMF submitted to regulatory agencies in the US is known as a USDMF. Codeine USDMF includes data on Codeine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Codeine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Codeine suppliers with USDMF on PharmaCompass.
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