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