01 1Pierre Fabre
01 1LEVOMILNACIPRAN
01 1France
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22351
Submission : 2008-12-22
Status : Active
Type : II
A Levomilnacipran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levomilnacipran, including repackagers and relabelers. The FDA regulates Levomilnacipran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levomilnacipran 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 Levomilnacipran manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levomilnacipran supplier is an individual or a company that provides Levomilnacipran active pharmaceutical ingredient (API) or Levomilnacipran finished formulations upon request. The Levomilnacipran suppliers may include Levomilnacipran API manufacturers, exporters, distributors and traders.
click here to find a list of Levomilnacipran suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levomilnacipran DMF (Drug Master File) is a document detailing the whole manufacturing process of Levomilnacipran active pharmaceutical ingredient (API) in detail. Different forms of Levomilnacipran DMFs exist exist since differing nations have different regulations, such as Levomilnacipran USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levomilnacipran DMF submitted to regulatory agencies in the US is known as a USDMF. Levomilnacipran USDMF includes data on Levomilnacipran's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levomilnacipran USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levomilnacipran suppliers with USDMF on PharmaCompass.
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