01 1Jagsonpal
02 1Wockhardt
03 1Blank
01 2D-OXYPHENE
02 1D-OXYPHENE BASE
01 2India
02 1Blank
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19632
Submission : 2006-07-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15543
Submission : 2001-06-20
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6191
Submission : 1986-02-22
Status : Inactive
Type : II
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A Dextrocarbinol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextrocarbinol, including repackagers and relabelers. The FDA regulates Dextrocarbinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextrocarbinol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Dextrocarbinol supplier is an individual or a company that provides Dextrocarbinol active pharmaceutical ingredient (API) or Dextrocarbinol finished formulations upon request. The Dextrocarbinol suppliers may include Dextrocarbinol API manufacturers, exporters, distributors and traders.
click here to find a list of Dextrocarbinol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dextrocarbinol DMF (Drug Master File) is a document detailing the whole manufacturing process of Dextrocarbinol active pharmaceutical ingredient (API) in detail. Different forms of Dextrocarbinol DMFs exist exist since differing nations have different regulations, such as Dextrocarbinol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dextrocarbinol DMF submitted to regulatory agencies in the US is known as a USDMF. Dextrocarbinol USDMF includes data on Dextrocarbinol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dextrocarbinol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dextrocarbinol suppliers with USDMF on PharmaCompass.
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