Abstract: Provided herein are impurities of cinacalcet, (R)-?-methyl-N-[3-[3-(trifluoromethyl)phenyl]propyl]-1-(5,6,7,8-tetrahydronaphthalene)methaneamine (tetrahydro cinacalcet impurity), (R)-?-Methyl-N-[3-[3-(trifluoromethyl)phenyl]propyl]-1-naphthalenemethaneamine-N-oxide (cinacalcet N-oxide impurity) and (R)-?-methyl-N-[3-[3-(trifluoromethyl)phenyl]methyl]-1-naphthalenemethaneamine (benzylamine impurity); and processes for preparation and isolation thereof. Provided further herein is a highly pure cinacalcet or a pharmaceutically acceptable salt thereof substantially free of impurities, processes for the preparation thereof, and pharmaceutical compositions comprising highly pure cinacalcet or a pharmaceutically acceptable salt thereof substantially free of impurities.

Abstract: Disclosed herein are convenient, industrially advantageous and environmentally friendly processes for the preparation of cinacalcet hydrochloride. Disclosed also herein are novel hydrochloride, oxalate and di-p-toluoyl-L-(+)-tartrate salts of (R)-?-methyl-N-[3-[3-(trifluoromethyl)phenyl]propylene]-1-naphthalenemethaneamine (unsaturated cinacalcet), solid state forms of the salts, and a process for their preparation thereof.

Abstract: The present invention relates to solid forms of (±)-O-desmethylvenlafaxine salts, processes for preparation, pharmaceutical compositions, and method of treating thereof. More particularly, the present invention provides solid forms of acid addition salts of (±)-O-desmethylvenlafaxine wherein the acid counter ion is provided by an acid selected from the group consisting of oxalic acid, benzoic acid and lactic acid.

Abstract: The present invention provides highly pure repaglinide substantially free of dimer impurity, and process for the preparation thereof. The present invention also relates to 2-ethoxy-N-[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzamide, an impurity of repaglinide, and a process for preparing and isolating thereof. The present invention further relates to pharmaceutical compositions comprising solid particles of pure repaglinide substantially free of dimer impurity or pharmaceutically acceptable salts thereof, wherein 90 volume-percent of the particles (D90) have a size of less than about 400 microns. The present invention also provides an optical resolution method of racemic 3-methyl-1-(2-piperidino-phenyl)-1-butylamine and use thereof for the preparation of repaglinide.

Abstract: Disclosed herein are co-crystals comprising O-desmethylvenlafaxine and succinic acid, process for the preparation, pharmaceutical compositions, and method of treating thereof.

Abstract: Process for the preparation of amorphous form of Atorvastatin calcium of Formula I 1

Abstract: There is disclosed, a process for lactonization to produce highly pure simvastatin of Formula I which comprises lactonization of a compound of Formula II where Z is H or NH4 in a mixture of acetonitrile and glacial acetic acid under anhydrous conditions at a temperature of 65-70° C.

Abstract: There is disclosed a process for the manufacture of simvastatin of Formula I which comprises heating a compound, namely acid or ammonium salt of compound of Formula II, where Z is H or NH4 in an organic solvent at a temperature of 130-140° C.

Abstract: There is disclosed, a process for lactonization to produce highly pure simvastatin of Formula I 1

Abstract: There is disclosed a process for the manufacture of simvastatin of Formula I 1

Abstract: A novel method for the synthesis of piperazine and its derivatives of formula 1, wherein R is selected from hydrogen, or a lower alkyl group having 1 to 6 carbon atoms or a phenylalkyl group the alkyl of which has 1 to 4 carbon atoms; R1 is selected from hydrogen, a methyl group, a phenyl group optionally substituted with an alkyl group having 1 to 6 carbon atoms, or a phenylalkyl group the alkyl of which has 1 to 4 carbon atoms; and R2 is selected from hydrogen, or a methyl group, or a fluoromethyl group; comprising the steps: a. reacting an ester of formula 11 with substituted or unsubstituted ethylenediamine of formula 7 to give 3,4-dehydropiperazine-2-one and its derivatives of formula 12, wherein R, R1, R2 are as defined above and R6 is a C1 to C4 linear or branched alkyl group; and b. reacting the 3,4-dehydro-piperazine-2-one and its derivatives of formula 12 with a reducing agent to yield the piperazine and its derivatives of formula 1.

Abstract: A novel method for the synthesis of piperazine and its derivatives of formula 1, 1