Abstract: The invention relates to stable pharmaceutical formulation useful for the oral administration comprising a peptide or protein drug and a permeation enhancer. In particular, the invention relates to stabilized pharmaceutical formulations comprising GLP-1 receptor agonist such as Semaglutide and a permeation enhancer and its process for preparation.

Abstract: The present invention relates to stable premix formulations for parenteral use and packaging for such formulations. The present invention relates to use of a single layer or multilayer film bags comprising polypropylene for packing premixed injectable formulations which remain stable during the storage period. The present invention relates to use of a single layer or multilayer film bags comprising polypropylene for packing dexmedetomidine premixed formulations. Such stable premixed formulations packed into a single layer or multilayer film bags comprising polypropylene are highly advantageous since they are ready-to-use, for example, in perioperative care of a subject in need thereof for sedation.

Abstract: The present invention relates to an extended release dosage form of highly water-soluble antidiabetic drug metformin or its pharmaceutically acceptable salts. This invention also relates to methods for preparing the extended release dosage forms of metformin or its pharmaceutically acceptable salts.

Abstract: The present invention relates to an improved process for the preparation of pure Finasteride of Formula I, which comprises converting dihydrofinasteride to finasteride through novel protected dihydrofinasteride and protected finasteride intermediates.

Abstract: The present invention is directed to a new process of preparing highly pure Florfenicol. The invention is further directed to new oxazolidine derivatives useful in making Florfenicol and processes of making these derivatives. Examples of such intermediates include (4R,5R)-3-acetyl-2,2-dimethyl-4-hydroxymethyl-5-[4-(methylsulfonyl)phenyl]-1,3-oxazolidine; and (4S,5R)-3-acetyl-2,2-dimethyl-4-fluoromethyl-5-[4-(methylsulfonyl)phenyl]-1,3-oxazolidine.

Abstract: The present invention describes an industrially advantageous process to prepare highly pure 1-Methyl-3-phenylpiperazine of Formula I that makes use of a novel piperazine derivative, 4-Benzyl-1-methyl-2-oxo-3-phenylpiperazine, represented by Formula II 1-Methyl-3-phenylpiperazine is a useful intermediate in the preparation of antidepressant Mirtazapine.

Abstract: The present invention relates to an improved process for the preparation of pure Finasteride of Formula I, which comprises converting dihydrofinasteride to finasteride through novel protected dihydrofinasteride and protected finasteride intermediates.

Abstract: The present invention relates to novel crystalline form of Cefdinir, 7?-[(Z)-2-(2-amino-4-thiazolyl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid, herein referred as cefdinir crystal B, processes for preparing cefdinir crystal B, and the incorporation of cefdinir crystal B in pharmaceutical compositions.

Abstract: This invention relates to a novel process to obtain highly pure 4-(cyclopropylcarbonyl)-?,?-dimethylphenylacetic acid of Formula I through crystallization from a mixture of para and meta regioisomers of Formula I and II in cyclohexane, whereby the amount of undesired meta isomer, 3-(cyclopropylcarbonyl)-?,?-dimethylphenylacetic acid of Formula II is decreased to below 0.5%. The compound of Formula I is a key intermediate for the preparation of high purity terfenadine carboxylate, which is a known antihistaminic.

Abstract: The present invention is directed to a new process of preparing highly pure Florfenicol. The invention is further directed to new oxazolidine derivatives useful in making Florfenicol and processes of making these derivatives. Examples of such intermediates include (4R,5R)-3-acetyl-2,2-dimethyl-4-hydroxymethyl-5-[4-(methylsulfonyl)phenyl]-1,3-oxazolidine; and (4S,5R)-3-acetyl-2,2-dimethyl-4-fluoromethyl-5-[4-(methylsulfonyl)phenyl]-1,3-oxazolidine.

Abstract: A novel process is disclosed for the preparation of Cefepime, a cephalosporin antibiotic, using novel new intermediates of the general Formula, where X represents Bromine or Chlorine atom This process comprises the step of cyclizing the bromo or chloro intermediate with thiourea to produce Cefepime of high purity. A process to prepare bromo or chloro intermediate comprising the acylation of 7-Amino-3-[(1-methyl-1-pyrrolidinium) methyl]-3-cephem-4-carboxylate with 4-halo-2-methoxyimino-3-oxobutyric acid halide is also described.

Abstract: The present invention describes an industrially advantageous process to prepare highly pure 1-Methyl-3-phenylpiperazine of Formula I 1

Abstract: Process for the preparation of amorphous form of Atorvastatin calcium of Formula I 1

Abstract: The present invention relates to novel crystalline form of Cefdinir, 7&bgr;-[(Z)-2-(2-amino-4-thiazolyl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid, herein called as cefdinir crystal B, process to prepare it and the use of cefdinir crystal B in pharmaceutical compositions.

Abstract: There is disclosed, a process for lactonization to produce highly pure simvastatin of Formula I which comprises lactonization of a compound of Formula II where Z is H or NH4 in a mixture of acetonitrile and glacial acetic acid under anhydrous conditions at a temperature of 65-70° C.

Abstract: There is disclosed a process for the manufacture of simvastatin of Formula I which comprises heating a compound, namely acid or ammonium salt of compound of Formula II, where Z is H or NH4 in an organic solvent at a temperature of 130-140° C.

Abstract: The present invention relates to an industrially advantageous method for the purification of Citalopram (Formula I) wherein desmethyl citalopram (Formula II), present in crude Citalopram as an impurity, is methylated to produce pure Citalopram.

Abstract: There is disclosed, a process for lactonization to produce highly pure simvastatin of Formula I 1

Abstract: This invention relates to a novel process to obtain highly pure 4-(cyclopropylcarbonyl) -&agr;, &agr;-dimethylphenylacetic acid of Formula I through crystallization from a mixture of para and meta regioisomers of Formula I and II in cyclohexane, whereby the amount of undesired meta isomer, 3-(cyclopropylcarbonyl)-&agr;,&agr;-dimethylphenylacetic acid of Formula 11 1

Abstract: There is disclosed a process for the manufacture of simvastatin of Formula I 1