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