01 2Tris Pharma Inc
01 1COD-CPM ER ORAL SUSPENSION
02 1COD-CPM-PSE ER ORAL SUSPENSION
01 2U.S.A
01 2Active
01 2Blank
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
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PharmaCompass offers a list of Codeine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Codeine manufacturer or Codeine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Codeine manufacturer or Codeine supplier.
A Codinex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Codinex, including repackagers and relabelers. The FDA regulates Codinex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Codinex 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 Codinex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Codinex supplier is an individual or a company that provides Codinex active pharmaceutical ingredient (API) or Codinex finished formulations upon request. The Codinex suppliers may include Codinex API manufacturers, exporters, distributors and traders.
click here to find a list of Codinex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Codinex DMF (Drug Master File) is a document detailing the whole manufacturing process of Codinex active pharmaceutical ingredient (API) in detail. Different forms of Codinex DMFs exist exist since differing nations have different regulations, such as Codinex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Codinex DMF submitted to regulatory agencies in the US is known as a USDMF. Codinex USDMF includes data on Codinex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Codinex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Codinex suppliers with USDMF on PharmaCompass.
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