The present disclosure provides industrially scalable methods of making (Z)-endoxifen or a salt thereof, crystalline forms of endoxifin, and compositions comprising them. The present disclosure also provides methods for treating hormone-dependent breast and hormone-dependent reproductive tract disorders.

The present disclosure provides industrially scalable methods of making (Z)-endoxifen or a salt thereof, crystalline forms of endoxifin, and compositions comprising them. The present disclosure also provides methods for treating hormone-dependent breast and hormone-dependent reproductive tract disorders.

A process for the conversion of glycolaldehyde with an aminating agent in the presence of hy-5 drogen and of a catalyst, wherein the conversion is carried out in the gas phase.

The present invention relates to new crystalline forms of vilanterol trifenatate, processes for their preparation, and their use in a pharmaceutical composition for the treatment of respiratory diseases, particularly for the treatment of asthma and chronic obstructive pulmonary disease. In particular, the present invention relates to a crystalline form of vilanterol trifenatate characterised in that the form has an XRPD pattern as defined herein having characteristic diffraction angles (2-theta or 20 (°)) falling within or at each end of one or more of the following ranges: (a) 3 to 5°, such as 3.8 to 4.4°; and/or (b) 7 to 9.9°, such as 7 to 8.5°; and/or (c) 12 to 13.3°, such as 12 to 13.3′; and/or (d) 16.4 to 17.3°, such as 16.4 to 17.3′; and/or (e) 26.8 to 28.3°, such as 26.8 to 28.3°.

The present invention relates to new crystalline forms of vilanterol trifenatate, processes for their preparation, and their use in a pharmaceutical composition for the treatment of respiratory diseases, particularly for the treatment of asthma and chronic obstructive pulmonary disease. In particular, the present invention relates to a crystalline form of vilanterol trifenatate characterised in that the form has an XRPD pattern as defined herein having characteristic diffraction angles (2-theta or 20 (°)) falling within or at each end of one or more of the following ranges: (a) 3 to 5°, such as 3.8 to 4.4°; and/or (b) 7 to 9.9°, such as 7 to 8.5°; and/or (c) 12 to 13.3°, such as 12 to 13.3′; and/or (d) 16.4 to 17.3°, such as 16.4 to 17.3′; and/or (e) 26.8 to 28.3°, such as 26.8 to 28.3°.

The present invention provides process for preparation of highly pure Fingolimod hydrochloride (I),

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without involving the use of column chromatographic purification in the entire process. Fingolimod hydrochloride (I) obtained by the process of present invention may be useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of autoimmune related disorder including multiple sclerosis.

The present invention provides process for preparation of highly pure Fingolimod hydrochloride (I),

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without involving the use of column chromatographic purification in the entire process. Fingolimod hydrochloride (I) obtained by the process of present invention may be useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of autoimmune related disorder including multiple sclerosis.

There is disclosed a process for recovering monoethanolamine from an aqueous mother liquor solution comprising the steps of: (a) adding excess ammonia or alkali hydroxide and a solvent to the aqueous solution comprised of monoethanolamine sulfate and at least one component selected from the group of inorganic salts consisting of ammonium sulfate, ammonium sulfite, alkali sulfite, and alkali sulfate, to precipitate the inorganic salts, wherein the alkali is lithium, sodium, or potassium; (b) separating the inorganic salts by means of a solid-liquid separation to yield an aqueous solution comprised of the monoethanolamine; and (c) distilling the solvent to yield an aqueous solution comprised of the monoethanolamine and optionally purifying the MEA by distillation. The recovered MEA is recycled to produce taurine.

There is disclosed a process for recovering monoethanolamine from an aqueous mother liquor solution comprising the steps of: (a) adding excess ammonia or alkali hydroxide and a solvent to the aqueous solution comprised of monoethanolamine sulfate and at least one component selected from the group of inorganic salts consisting of ammonium sulfate, ammonium sulfite, alkali sulfite, and alkali sulfate, to precipitate the inorganic salts, wherein the alkali is lithium, sodium, or potassium; (b) separating the inorganic salts by means of a solid-liquid separation to yield an aqueous solution comprised of the monoethanolamine; and (c) distilling the solvent to yield an aqueous solution comprised of the monoethanolamine and optionally purifying the MEA by distillation. The recovered MEA is recycled to produce taurine.

The present invention concerns a novel process for preparing solriamfetol hydrochloride.