01 2SAFC
01 2MEBROFENIN
01 2U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30548
Submission : 2016-09-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15863
Submission : 2002-02-18
Status : Inactive
Type : II
A Mebrofenin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mebrofenin, including repackagers and relabelers. The FDA regulates Mebrofenin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mebrofenin 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 Mebrofenin supplier is an individual or a company that provides Mebrofenin active pharmaceutical ingredient (API) or Mebrofenin finished formulations upon request. The Mebrofenin suppliers may include Mebrofenin API manufacturers, exporters, distributors and traders.
click here to find a list of Mebrofenin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mebrofenin DMF (Drug Master File) is a document detailing the whole manufacturing process of Mebrofenin active pharmaceutical ingredient (API) in detail. Different forms of Mebrofenin DMFs exist exist since differing nations have different regulations, such as Mebrofenin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mebrofenin DMF submitted to regulatory agencies in the US is known as a USDMF. Mebrofenin USDMF includes data on Mebrofenin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mebrofenin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mebrofenin suppliers with USDMF on PharmaCompass.
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