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