Teva Pharmaceutical Industries Limited

Mili Abramov

Santiago Ini

Anita Liberman

Sigalit Levi

Eran Turgeman

Judith Aronhime

Tamas Koltai

Michal Rafilovich

Yaron Shmuely

Alexei Ploutno

Osnat Porter-Kleks

Dina Berezovsky

Ron Bar-Shavit

The invention encompasses novel amorphous and crystalline forms of carvedilol phosphate, carvedilol hydrogen phosphate, and carvedilol dihydrogen phosphate as well as methods of making the novel amorphous and crystalline forms. Also disclosed are pharmaceutical compositions comprising the novel amorphous and crystalline forms and uses thereof.

Amorphous carvedilol dihydrogen phosphate

Carvedilol phosphate

(S)-N,N-Dimethyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine maleate (DNT-maleate) and polymorphs of DNT-maleate, compositions of DNT-maleate and its polymorphs, processes for the preparation of DNT-maleate and its polymorphs, and processes for the preparation of duloxetine hydrochloride from DNT-maleate are provided.

DNT-maleate and methods of preparation thereof

The invention encompasses 2-(N-methyl-propanamine)-3-(2-naphthol)thiophene, a duloxetine hydrochloride impurity, as well as its use as a reference marker and reference standard.

2-(N-methyl-propanamine)-3-(2-naphthol)thiophene, an impurity of duloxetine hydrochloride

A chiral resolution process for the preparation of (S)-AT-OL, and a process for the racemization of AT-OL are provided.

Process for the preparation of (S)-(-)-N,N-dimethyl-3-(2-thienyl)-3-hydroxypropananine, a duloxetine intermediate

Process for the purification of duloxetine HCl is provided.

Process for the purification of duloxetine hydrochloride

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Givataim, Israel

Mili Abramov