01 1Calyx Chemicals & Pharmaceuticals Limited
02 1Cipla
03 1Ipca Laboratories
04 1Micro Labs Limited
05 1Shanghai Desano Bio-Pharmaceutical
06 1Solara Active Pharma Sciences
01 5LUMEFANTRINE
02 1LUMEFANTRINE USP
01 1China
02 5India
01 3Active
02 3Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23966
Submission : 2010-07-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20172
Submission : 2008-04-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22221
Submission : 2009-01-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28108
Submission : 2014-03-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26766
Submission : 2012-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23561
Submission : 2010-02-22
Status : Active
Type : II
A Lumefantrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lumefantrine, including repackagers and relabelers. The FDA regulates Lumefantrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lumefantrine 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 Lumefantrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lumefantrine supplier is an individual or a company that provides Lumefantrine active pharmaceutical ingredient (API) or Lumefantrine finished formulations upon request. The Lumefantrine suppliers may include Lumefantrine API manufacturers, exporters, distributors and traders.
click here to find a list of Lumefantrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lumefantrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Lumefantrine active pharmaceutical ingredient (API) in detail. Different forms of Lumefantrine DMFs exist exist since differing nations have different regulations, such as Lumefantrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lumefantrine DMF submitted to regulatory agencies in the US is known as a USDMF. Lumefantrine USDMF includes data on Lumefantrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lumefantrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lumefantrine suppliers with USDMF on PharmaCompass.
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