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 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, and COA 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, and COA 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.
We have 1 companies offering Codeine
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