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