Abstract: The present invention discloses a stable pharmaceutical formulation of an antibody, wherein the formulation contains buffer, surfactant, sugar, and optionally contains a free amino acid. The disclosed formulation is stable at 50° C. for two weeks. In addition, the formulation maintains at least 96% of the antibody in monomeric form under above said storage conditions.

Abstract: The present invention discloses a stable pharmaceutical formulation of an antibody, wherein the formulation contains buffer, surfactant and salt, and wherein the formulation is devoid of free amino acids. The disclosed antibody formulations are liquid formulations that are also suitable for lyophilization.

Abstract: The present invention provides a stable liquid formulation of an antibody in phosphate-amino acid based dual buffer system. The antibody formulated in phosphate-amino acid based dual buffer system imparts optimum stability to the antibody, at lower as well as higher concentrations. Further, the antibody formulated in phosphate-amino acid based buffer system has low viscosity and is suitable for therapeutic administration of high concentrations of antibody.

Abstract: Aspects of the present application relate to process for the preparation of Omecamtiv mecarbil and salts thereof. Specific aspects relate to novel urea intermediate, preparative process thereof and its use in the preparation of Omecamtiv mecarbil and salts thereof. The improved process for the preparation of Omecamtiv mecarbil are industrially viable.

Abstract: Aspects of the present application relate to solid forms of Omecamtiv mecarbil dihydrochloride. Specific aspects relate to crystalline forms and amorphous solid dispersions of Omecamtiv mecarbil dihydrochloride. Further specific aspects related to crystalline forms DP1, DP2, DP3, DP4, OMT-D, OMT-L, OMT-O, OMT-F, OMT-FS and amorphous solid dispersions of Omecamtiv mecarbil dihydrochloride and pharmaceutical compositions thereof.

Abstract: The present application provides process for preparation of siponimod, intermediates of siponimod, salts of siponimod, polymorphic forms and solid dispersions of siponimod and its salts thereof. The present application specifically provides crystalline polymorphic forms of siponimod base, siponimod hemifumarate and other salts and pharmaceutical compositions thereof. Also provided are solid dispersions of siponimod hemifumarate and pharmaceutical compositions containing them.

Abstract: The present invention relates to stable liquid pharmaceutical formulations of cyclophosphamide comprising cyclophosphamide and at least one pharmaceutically acceptable excipient wherein moisture content of the liquid formulation is less than about 2.0% by weight. The invention further relates to stable liquid formulations of cyclophosphamide prepared by a process comprising a step of reducing the moisture content from cyclophosphamide or liquid compositions of cyclophosphamide or both. The invention further relate to method of using such stable liquid formulations of cyclophosphamide for parenteral administration either as ready-to-use or ready-to-dilute for treating various cancer disorders.

Abstract: The present application relates to solid state forms of Lumateperone p-Tosylate and processes for preparation thereof. The present application provides amorphous Lumateperone p-tosylate and a solid dispersion comprising amorphous Lumateperone p-tosylate and one or more pharmaceutically acceptable polymers and processes for preparation thereof. The compounds are useful as 5-HT2 receptor agonists and antagonists used in treating disorders of the central nervous system including a disorder associated with 5HT2C or 5HT2A receptor modulation.

Abstract: The present invention provides crystalline Roxadustat Form-?, crystalline Roxadustat Form-?, process for the preparation of crystalline Roxadustat Form-?, crystalline Roxadustat Form-? and its pharmaceutical compositions thereof. The present invention also provides co-crystals of Roxadustat Form RLP, Roxadustat Form RNM and Roxadustat Form RU, process for their preparation and pharmaceutical composition thereof.

Abstract: The present application relates to amine salt of obeticholic acid. Specifically, the present application relates to (S)-?-methylbenzylamine and diethylamine salt of obeticholic acid. The present application also relates to a process for preparation of amorphous form of obeticholic acid comprising converting amine salt of obeticholic acid to amorphous form of obeticholic acid.

Abstract: The present invention discloses a stable pharmaceutical formulation of an antibody, wherein the formulation contains buffer, surfactant and salt, and wherein the formulation is devoid of free amino acids. The disclosed antibody formulations are liquid formulations that are also suitable for lyophilization.

Abstract: The present invention provides a crystalline form of Lenvatinib Mesylate, processes for the preparation of crystalline form of lenvatinib Mesylate and pharmaceutical compositions thereof. The crystalline form of lenvatinib Mesylate designated as Form VN1 is characterized by powder X-ray diffraction pattern. The present invention further provides a process for the preparation of amorphous form of lenvatinib Mesylate. The amorphous form is characterized by powder X-ray diffraction pattern.

Abstract: The present application relate to a process for preparation of 4-Methylene tetrahydrofuran compound of formula II, which is useful as an intermediate for the preparation of halichondrin B analogues such as Eribulin.

Abstract: Aspects of the present application relate to solid forms of Selinexor, processes for their preparation and pharmaceutical compositions thereof. Specific aspects relate to crystalline and amorphous forms of Selinexor.

Abstract: The invention of the present application relates to the process for the preparation of intermediates of obeticholic acid and their conversion to obeticholic acid. The process involves the conversion of compound of formula (VI) to compound of formula (VII) in presence of an organic base.

Abstract: The present invention relates to novel impurities of cyclophosphamide having structure V, VI or VII, stabilized form of these novel impurities, a process of preparing a stabilized form and isolating thereof. The invention also relates cyclophosphamide formulations which include cyclophosphamide, at least one pharmaceutically acceptable excipient, and a certain level of these impurities having structure V, VI or VII. The invention further relate to method of using such stable liquid formulations of cyclophosphamide for parenteral administration in treating various cancer disorders.

Abstract: The present application relate to process for preparation of tetrahydrofuran compound of formula II, 4-Methylene tetrahydrofuran compound of formula V and tetrahydropyran compound of formula IX which are useful as intermediates for the preparation of halichondrin B analogues such as Eribulin or its pharmaceutically acceptable salts.

Abstract: The present application relates to a process for the preparation of crystalline form A of palbociclib having specific surface area more than 2 m2/g comprising one-pot process for the preparation of compound of formula (IV). The present application further relates to the preparation of acid-addition salts of palbociclib and their use for the synthesis of crystalline form A of palbociclib having specific surface area more than 2 m2/g.

Abstract: The present application relates to crystalline propylene glycol solvate of acalabrutinib and process for preparation thereof. The propylene glycol solvate of acalabrutinib may be selected from a group of racemic propylene glycol solvate, R-propylene glycol solvate and S-propylene glycol solvate of acalabrutinib. Specifically, the present application relates to crystalline forms RSV1, RSV2, RSV3 and RSV4 of acalabrutinib. Crystalline forms RSV2 and RSV3 are stable in all conditions and has excellent physico-chemical properties. The present application also relates to crystalline form RSVS of acalabrutinib.

Abstract: The invention relates to a cell culture process for decreasing the galactosylated content and/or increasing the G0F content of a glycoprotein. The process involves subjecting recombinant cells expressing the said glycoprotein to a temperature and pH shift and supplementing cell culture with glutamine.