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DMFs Filed

 

 

 

S. NoProduct NameRegulatory AgencyDMF No.
1Abacavir (base)IT,PL,DE,NL,ES etcASMF no. available from EU regions
2Atazanavir sulphate Form AUS FDA28952
3Capecitabine Ph.Eur.CEP/EDQMR0 CEP-2013-309
4Capecitabine USPUS FDA25054
5Capecitabine USPMHRA – UKMFD-39882-1-11433-0001
6DasatinibIT,PL,DE,NL,ES etcASMF no. available from EU regions
7Efavirenz USPUS FDA24847
8Efavirenz USPWHOAPIMF173
9Imatinib Mesylate α FormIT,PL,DE,NL,ES etcASMF no. available from EU regions
10Imatinib Mesylate α FormUS FDA26424
11Imatinib mesylate α FormCEP/EDQMCEP 2018-262 under review.
12Imatinib Mesylate β FormUS FDA26322
13Lopinavir USPUS FDA28244
14Tenofovir Disoproxil FumarateWHOAPIMF219
15Tenofovir Disoproxil FumarateUS FDA27143
16SunitinibIT,PL,DE,NL,ES etcASMF no. available from EU regions
17SunitinibHealth Canada2018-202
18Erlotinib Form AIT,PL,DE,NL,ES etcASMF no. available from EU regions
19Erlotinib Form AUS FDA033226
20Pemetrexed Disodium  2.5 hydrateUS FDA032639
21Pazopanib HClUS FDA033054
22PalbociclibUSDMF033055