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 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 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 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: The present invention provides novel salts of nilotinib and polymorphs thereof. The acid addition salts of nilotinib with benzenesulfonic acid, butanedisulfonic acid, 1-5-naphthalenedisulfonic acid, naphthalene-1-sulfonic acid and 1-hydroxynaph-thoic acid; hydrates and anhydrates thereof.

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 relates to the anti dengue activity of the cissampelos pareira extracts. Pharmaceutical compositions comprising extracts of cissampelos pareira and processes for the preparation of extracts of cissampelos pareira are also provided.

Abstract: An oral pharmaceutical composition of isotretinoin with reduced food effect. A process for preparing the oral pharmaceutical composition of the present invention.

Abstract: This disclosure provides an extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units, wherein said capsule dosage form is bioequivalent to the marketed Toprol-XL® tablet. The extended-release capsule dosage form comprising coated discrete units can be sprinkled onto food to ease administration to patients who have difficulty swallowing tablets or capsules.

Abstract: The present invention relates to a method of treating acne or psoriasis by topically administering Tazarotene substantially free of dimer impurity of formula 4,4-dimethyl-6-[4-(4,4-dimethylthiochroman-6-yl)-buta-1,3-diynyl]-thiochroman.

Abstract: The present invention relates to a pharmaceutical gastro-retentive solid oral dosage form comprising nilotinib as the active ingredient. The invention is further related to methods of preparing said dosage form.

Abstract: The present invention relates to a dapagliflozin-citric acid co-crystal, processes for its preparation, and its use for the treatment of type 2 diabetes mellitus. A dapagliflozin citric acid co-crystal. The dapagliflozin citric acid co-crystal of claim 1, characterized by X-ray powder diffraction peaks having d-spacing values at about 3.89, 3.90, 4.01, 4.35, 5.77, and 5.80.

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.