Abstract: The present invention relates to a stable amorphous ticagrelor and a process for its preparation.

Abstract: The present invention provides a crystalline Form I of afatinib dimaleate, its process for preparation and pharmaceutical composition thereof, and its use in the treatment of metastatic non-small cell lung cancer.

Abstract: An oral pharmaceutical composition of isotretinoin and a carrier substrate, having isotretinoin in the form of gel, dispersion, solution or emulsion, which is absorbed onto the carrier substrate to form solid particles, powder, or granules. The oral pharmaceutical composition has enhanced bioavailability. A process is used for preparing the oral composition.

Abstract: The present invention relates to a ready-to-administer parenteral dosage form of norepinephrine which comprises an aqueous solution of norepinephrine, having an anti-oxidant which is not a sulfite anti-oxidant, wherein the dosage form is stable at room temperature for prolonged period of time.

Abstract: The present invention relates to a method for preparing a stable extended release suspension composition comprising multiple coated cores of an active ingredient by using a suspension base, wherein the suspension base ensures substantially similar in-vitro dissolution release profile of the active ingredient upon storage of the suspension compositions for at least seven days.

Abstract: The present invention relates to oral liquid compositions of guanfacine. The liquid compositions can be immediate release or extended release compositions. The compositions comprise guanfacine in a concentration from about 0.1 mg/mL to about 12.0 mg/mL of the composition. The liquid compositions can be in the form of ready-to use liquid compositions or reconstituted liquid compositions. It further relates to processes for the preparation of said oral liquid compositions.

Abstract: The present invention provides a crystalline form of baricitinib characterized by an XRPD pattern substantially as depicted in FIG. 1, a process for its preparation, a pharmaceutical composition comprising it, and its use for the treatment of JAK-associated diseases.

Abstract: The present invention relates to a modified-release, once-daily, oral pharmaceutical composition comprising isotretinoin and a process for its preparation. In some embodiments, the disclosure is directed to a modified-release, oral pharmaceutical composition comprising isotretinoin or a pharmaceutically acceptable salt, ester or a derivative thereof; and a release modifying agent, wherein the composition is suitable for once daily administration. In some embodiments, the disclosure is directed to a modified-release, oral pharmaceutical composition comprising isotretinoin, wherein the composition comprises an immediate-release component; and a modified-release component comprising a release modifying agent, and wherein the composition is suitable for once daily administration.

Abstract: The present invention relates to a ready-to-administer parenteral dosage form of norepinephrine which comprises an aqueous solution of norepinephrine, having an anti-oxidant which is not a sulfite anti-oxidant, wherein the dosage form is stable at room temperature for prolonged period of time.

Abstract: The present invention provides a process for the preparation of baricitinib and an intermediate thereof. The present invention provides a convenient, economical, and industrially advantageous two-step process for the preparation of [4-(IH-pyrazol-4-yl)-7Hpyrrolo[2,3-d] pyrimidin-7-yl]methyl pivalate of Formula (II). The process of the present invention involves the use of an alkali or alkaline earth metal hydroxide, carbonate, or bicarbonate as a base for reacting 4-chloro-7H-pyrrolo[2,3-d]pyrimidine of Formula (III) with chloromethyl pivalate of Formula (IV), and the use of an unprotected pyrazole borolane of Formula (VIII) for the conversion of (4-chloro-7H-pyrrolo[2,3-d] pyrimidin-7-yl)methyl 2,2-dimethylpropanoate of Formula V into [4-(1H-pyrazol-4-yl)-7Hpyrrolo[2,3-d]pyrimidin-7-yl]methyl pivalate of Formula (II). The process of the present invention provides [4-(1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl]methyl pivalate of Formula (I) in high yield.

Abstract: The present invention relates to a gastroretentive extended release suspension composition, wherein the composition is characterized by having no substantial change in the in-vitro dissolution release profile upon storage for at least seven days. The invention also relates to processes for the preparation of said gastroretentive extended release suspension compositions.

Abstract: The present invention relates to an osmotic floating tablet comprising: (i) an inner core comprising a drug, one or more low density polymers, and one or more pharmaceutically acceptable excipients; and (ii) an outer osmotic coating surrounding the inner core that is substantially permeable to surrounding fluids and substantially impermeable to the drug. The present invention also relates to processes for the preparation of said tablets.

Abstract: The present invention relates to stable pharmaceutical compositions comprising rifaximin and processes for their preparation.

Abstract: The present invention provides a process for the preparation of pazopanib of Formula Ia or salts, and intermediates thereof.

Abstract: The present invention provides a process for the preparation of 4-dimethylaminocrotonic acid of Formula (II) or its salts, which is used as an intermediate for the preparation of afatinib or its salts.

Abstract: The present invention relates to a stable, sterile, ready to administer parenteral dosage form of amiodarone or its pharmaceutically acceptable salt. Particularly, the present invention provides a stable, sterile, ready to administer parenteral dosage form of amiodarone comprising an aqueous solution comprising amiodarone or its pharmaceutically acceptable salt, an acid, and a polyol, wherein the pH of the solution is in the range of about 2.0 to 4.0, wherein the solution is filled in a plastic container and wherein the solution is free of a solubilizer.

Abstract: The present invention provides a sterile solution comprising leuprolide acetate in a pharmaceutically acceptable vehicle, wherein solution is present as a reservoir in a multiple dose pen injection device, the device being adapted to subcutaneously inject a portion of the said reservoir in a single daily dose and further being adapted to provide multiple portions of solution said while the reservoir remains sterile.

Abstract: The present invention provides a low dose oral pharmaceutical composition of isotretinoin having reduced food effect, in particular no food effect. The present invention further relates to a process for preparing the oral pharmaceutical composition of the present invention.

Abstract: The present invention relates to controlled-release pharmaceutical dosage forms comprising a solid dispersion of a poorly water-soluble or insoluble drug with improved solubility and thus improved dissolution in an aqueous medium. The invention further discloses a process of preparation of these controlled-release dosage forms.

Abstract: The present invention provides a crystalline Form I of afatinib dimaleate, its process for preparation and pharmaceutical composition thereof, and its use in the treatment of metastatic non-small cell lung cancer.