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