Approvals and DMFs


Product Name Regulatory Agency APIMF/ASMF/DMF number assigned
by  Regulatory Agency
Status
Lumefantrine (Ph.Int.)
WHO Geneva
APIMF 100/WHOAPI 100
Approved
Amodiaquine Hydrochloride
WHO Geneva
APIMF 134/WHOAPI 134
Approved
Artesunate (Ph.Int.)
WHO Geneva
APIMF 135/WHOAPI 135
Approved
Artemether (Ph.Int.)
WHO Geneva
APIMF 138/WHOAPI 138
Approved
Piperaquine Phosphate
WHO Geneva and EMA
WHOAPI 149 and EMEA/ASMF/01007
Approved
Dihydroartemisinin
WHO-Geneva and EMA
WHOAPI 151and EMEA/ASMF/01008
Approved
Tenofovir Disoproxil Fumarate
WHO-Geneva
APIMF 204/WHOAPI 204
Approved
Furosemide (Ph.Eur.)
BfArM, Germany
ASMF Ref No. 11.02-3620-2604
Approved
Allopurinol (Ph.Eur.)
EDQM
CEP 2011-067/ Allopurinol
Approved
Nimesulide (Ph.Eur.)
EDQM
CEP 2011-310/ Nimesulide
Approved
Emtricitabine
WHO-Geneva
APIMF 314/WHOAPI 314
Approved
Efavirenz
WHO-Geneva
WHOAPI 318
Under Assessment