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