Abstract: The present invention relates to novel pharmaceutically acceptable salts of Bempedoic acid, novel intermediates of Bempedoic acid, novel crystalline form of Bempedoic acid and novel processes for the preparation of Bempedoic acid or its intermediates thereof.

Abstract: Various crystalline and amorphous solid state forms of an apoptosis-inducing agent and preparations thereof are disclosed. Also discloses the use of crystalline forms for the preparation of amorphous form of apoptosis-inducing agent. Further discloses a process for preparation of the apoptosis-inducing agent.

Abstract: The present invention provides process for preparation of cysteamine bitartrate comprising reacting cysteamine or its salt with tartaric acid. The present invention further provides crystalline form L1 of cysteamine bitartrate having characteristic diffraction peaks at 10.36, 14.54, 17.23, 18.03, 19.24, 20.76, 21.20, 22.02, 23.37, 23.64, 27.71, 28.28, 29.26, 31.33, 32.84, 33.83, 35.51, 36.74±0.2 degree two theta in an X-ray diffraction pattern and process for preparation thereof. The present invention provides crystalline form L2 of cysteamine bitartrate having characteristic diffraction peaks at 7.4, 10.3, 11.0, 11.4, 14.4, 14.9, 18.6, 19.4, 20.1, 20.8, 21.9, 22.3, 22.5, 23.5±0.2 degree two theta in an X-ray diffraction pattern and process for preparation thereof.

Abstract: A one-pot process is disclosed for the preparation of pharmaceutical grade ferric citrate that includes preparing a ferric hydroxide slurry followed by treatment with a citrate ion source to yield pharmaceutical grade ferric citrate.

Abstract: The present invention provides process for preparation of cysteamine bitartrate comprising reacting cysteamine or its salt with tartaric acid. The present invention further provides crystalline form L1 of cysteamine bitartrate having characteristic diffraction peaks at 10.36, 14.54, 17.23, 18.03, 19.24, 20.76, 21.20, 22.02, 23.37, 23.64, 27.71, 28.28, 29.26, 31.33, 32.84, 33.83, 35.51, 36.74±0.2 degree two theta in an X-ray diffraction pattern and process for preparation thereof. The present invention provides crystalline form L2 of cysteamine bitartrate having characteristic diffraction peaks at 7.4, 10.3, 11.0, 11.4, 14.4, 14.9, 18.6, 19.4, 20.1, 20.8, 21.9, 22.3, 22.5, 23.5±0.2 degree two theta in an X-ray diffraction pattern and process for preparation thereof.

Abstract: The present invention provides one pot process for preparation of highly pure unsaturated cinacalcet hydrochloride (II) comprising: i) converting 3-(trifluromethyl) cinnamic acid (III) into 3-(3-(trifluoromethyl)phenyl)prop-2-en-1-ol (IV), ii) converting 3-(3-(trifluoromethyl)phenyl)prop-2-en-1-ol (IV) to compound (V), wherein R is Cl, Br, I, tosylate and mesylate, Formula (V) iii) reacting compound (V) with (R)-1-(1-Naphthyl) ethylamine (VI) in presence of base followed by treatment with hydrochloric acid. The present invention further provides conversion of unsaturated cinacalcet hydrochloride (II) to cinacalcet hydrochloride (I).

Abstract: The present invention relates to a novel process for preparation of rufinamide (I) comprising: reacting 2,6-difluorobenzyl azide (II) and propiolic acid (III) in a mixture of alcohol and water to produce 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxylic acid (IV), esterifying the acid (IV) to ester (V) and treating ester (V) with ammonia. The invention further relates to process for purification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxylic acid (IV), by crystallization from a mixture of alcohol and water. The present invention also provides process for purification of rufinamide (I) by crystallization from mixture of polar aprotic solvent with water or alcohol.

Abstract: An improved process for synthesis of duloxetine hydrochloride (1) having chiral purity greater than 99.9% that is characterized by the following: (i) preparation of racemic condensed compound (RS)—N,N-di methyl-3-(1-naphthyloxy)-3-(2-thienyl)propanamine (4) by reaction of racemic hydroxy compound (2) with 1-fluoronaphthalene (3) in presence of a base such as sodamide, potassium amide or potassium bis(trimethylsilyl)amide (KHDMS) in polar aprotic solvent, (ii) optical resolution of racemic condensed compound (5a+5b) with di-benzoyl-L-tartaric acid (7, DBTA, R=H) or di-para-anisoyl-L-tartaric acid (7, DATA, R=OCH3) to obtain crude (S)—N.N-dimethyl-3-(1-naphthyloxy)-3-(2-thienyl)propanamine dibenzoyl tartarate salt (8a) or (S)—N.

Abstract: An improved process for synthesis of duloxetine hydrochloride (1) having chiral purity greater than 99.

Abstract: A process for preparation of perindopril of formula (II) and salts thereof which is simple, safe, convenient and cost-effective. The process involves reaction of compound of formula (I), wherein X is chlorine or bromine with compound of formula (VII) wherein A signifies that the six-membered ring of the bicyclic system is either saturated or unsaturated to give compound of formula (VIII), wherein A is as defined above, followed by catalytic hydrogenation of the compound of formula (VIII) thus obtained to give the perindopril of formula (II). The above process for the manufacture of perindopril would specifically avoid the use of harmful chemicals like phosgene or costly coupling agents like dicyclohexylcarbodiimide and 1-hydroxybenxotriazole usually used for such manufacture. The process would also not require any intervention of a catalyst and does not require any alkaline or acidic reaction conditions.