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