01 1Apicore LLC
01 1FLIBANSERIN
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35336
Submission : 2020-11-12
Status : Active
Type : II
A Flibanserin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flibanserin, including repackagers and relabelers. The FDA regulates Flibanserin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flibanserin 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 Flibanserin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flibanserin supplier is an individual or a company that provides Flibanserin active pharmaceutical ingredient (API) or Flibanserin finished formulations upon request. The Flibanserin suppliers may include Flibanserin API manufacturers, exporters, distributors and traders.
click here to find a list of Flibanserin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flibanserin DMF (Drug Master File) is a document detailing the whole manufacturing process of Flibanserin active pharmaceutical ingredient (API) in detail. Different forms of Flibanserin DMFs exist exist since differing nations have different regulations, such as Flibanserin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flibanserin DMF submitted to regulatory agencies in the US is known as a USDMF. Flibanserin USDMF includes data on Flibanserin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flibanserin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flibanserin suppliers with USDMF on PharmaCompass.
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