Abstract: The present application relates to a process for the preparation of semaglutide. The present application also relates to a recombinant process for the preparation of semapeptide. The present invention is related to a process for producing semapeptide, the process comprising the steps of, a) culturing a host cell comprising a nucleotide sequence encoding of Formula (II) under suitable conditions for expression, wherein, insoluble tag is a nucleotide sequence of Alanine-Valine; b) recovering semapeptide, wherein semapeptide amino acid sequence is Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys-Glu-Phe-Ile-Ala-Trp-Leu-Val-Arg-Gly-Arg-Gly.

Abstract: The present invention relates to process for the continuous manufacture of Statins or salts thereof. The present invention relates to process for the continuous manufacture of Atorvastatin or a salt thereof. The present invention relates to a continuous manufacturing process for the crystallization of Atorvastatin calcium. The present invention also relates to a continuous manufacturing process for the crystallization of Atorvastatin calcium Form I.

Abstract: The present application relates to improved and effective purification processes and also relates to method of increasing the solubility of for GLP-1 analog and its derivatives particularly Liraglutide. The purification process of present application is advantageous not only in terms of providing the highly pure peptide chemically but also in terms of affording peptide drug substance which is having good physical stability even at a large scale during holding or in-use period, while making drug substance compatible for formulation.

Abstract: Aspect of the present application relates to process for the preparation of crystalline form of Apalutamide and process for the preparation of Apalutamide in the presence of neutralizing agent selected from triethylsilylchloride, trimethylsilyl chloride, zinc chloride, aluminium chloride, iron chloride, sodium chloride, acetic acid, ammonium chloride or mixture thereof followed by treating with acid to obtain Apalutamide.

Abstract: The present invention provides substantially pure venetoclax, process for the preparation of substantially pure venetoclax and pharmaceutical formulation of substantially pure venetoclax. In another aspect present invention provides amorphous venetoclax in a free drug particulate form, process for the preparation of amorphous venetoclax in a free drug particulate form and pharmaceutical formulation of amorphous venetoclax in a free drug particulate form.

Abstract: The present application relates to a process for the preparation of midostaurin by controlling critical impurities or by-products which in turn lead to increase in the overall yield and purity. The present application also provides midostaurin having less than 0.15% or substantially free or free of one or more impurities.

Abstract: The present application relate to a purification process for preparation of halichondrin B analogues such as eribulin or pharmaceutically acceptable salts thereof having less than 0.15% or substantially free or free from one or more impurities. The present application also provide acid addition salts of eribulin and process for preparation thereof.

Abstract: The present invention provides optically pure (S)-(+)-N-methyl-3-(1-naphthaleneoxy)-3-(2-thienyl)propanamine, a compound of formula (I), and optically pure (S)-isomer of compound of formula 4, wherein R1 and R2 both are methyl or R1 is methyl and R2 is benzyl or substituted benzyl group and process for preparation thereof. Formula (I) and (IV). In another aspect the present invention provides a process for preparation of an acid addition salt of compound of formula (I).

Abstract: The present invention provides a process for preparation of 1-[9H-carbazol-4-yloxy]-3-[{2-(2-(methoxy)phenoxy)-ethyl}-amino]-propan-2-ol, a compound of formula 1 in racemic form or in the form of optically active R or S enantiomer or its pharmaceutically acceptable salt, comprising, reacting 4-(oxiranylmethoxy)-9H-carbazole, a compound of formula (2) or the R or S enantiomer thereof with a compound of formula (5), wherein R1 is benzyl or substituted benzyl group, in an aprotic organic solvent in presence of a catalyst to obtain a compound of formula (6), or the R or S enantiomer thereof, wherein R1 is as defined above. The resultant compound of formula (6) is subjected to debenzylation reaction by catalytic hydrogenation to obtain the compound of formula (1), if desired converting the resultant compound of formula (1) to a pharmaceutically acceptable salt thereof.

Abstract: The present invention provides a novel process for preparation of trans-3-ethyl 2,5-dihydro-4-methyl-N-[2-[4-[[[[(4-methyl cyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-2-oxo-1H-pyrrole-1-carboxamide via the novel intermediate compounds of formula 3.