Abstract: The present invention relates to an improved process for preparation of Dasatinib monohydrate Formula A, comprising the steps of: a) reacting the compound of Formula I with 1-(2-Hydroxyethyl)piperazine (Formula II) in the presence of acetonitrile solvent, an organic base and a phase transfer catalyst; b) heating the reaction mixture at 50-80° C.; c) adding water to the reaction mass obtained in step b); d) cooling the reaction mixture to a temperature below 35° C.; e) filtering and drying the material obtained in step d); f) optionally purifying the product obtained from step e); g) isolating the crystalline Dasatinib monohydrate.

Abstract: The present invention provides an industrially suitable process for the preparation of substantially pure 4-{4-[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]phenoxy}-N-methylpyridine-2-carboxamide or Sorafenib and its tosylate salt, with a suitable impurity profile and without requirement of any additional purification steps. The present invention also provides Sorafenib base (II) as stable crystalline Form-SSB. The present invention further relates to a process for the preparation of crystalline Sorafenib tosylate Form-I which is free from contamination of any other polymorphic form of Sorafenib tosylate, for e.g. Form II or Form III, and does not involve any seeding requirement for crystallization step.

Abstract: The present invention provides an improved process for preparing N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazole carboxamide monohydrate or Dasatinib monohydrate (Formula A).