Abstract: The present invention relates to an improved process for the preparation of Isavuconazonium sulfate. The present invention also provides a process for the preparation of key starting materials used for the preparation of Isavuconazonium sulfate.

Abstract: The present application provides stable ready-to-use injectable formulations of melphalan, methods for preparing storage-stable, ready-to-use injectable formulations that include melphalan, which are easy to administer without need of any reconstitution step and has a desirable solubility, stability, and safety profile. In other embodiments, provided are storage-stable, ready-to-use, injectable liquid parenteral formulations that include melphalan and other pharmaceutically acceptable excipients.

Abstract: Liquid parenteral formulations are provided that include tigecycline and at least one or more pharmaceutically acceptable excipient or adjuvant, where the formulation is ready to use without additional steps for reconstitution at the time of administration.

Abstract: The invention relates to an improved composition of ferric maltol or ferric trimaltol for the treatment of iron deficiency, wherein the composition comprises the active ferric maltol or ferric trimaltol lower than 60% of the total composition weight. The compositions further can be a capsule or tablet or any other pharmaceutical solid dosage form, preferably a capsule in a hard gelatin in a size of 0 or 1, for oral administration.

Abstract: The present application provides processes for the purification of ferric carboxymaltose, the process includes the steps of dissolving crude ferric carboxymaltose in a first solvent; charging the ferric carboxymaltose solution in a reaction vessel with a second solvent and precipitating therefrom a ferric carboxymaltose precipitate; and isolating pure ferric carboxymaltose from the ferric carboxymaltose precipitate.

Abstract: The present application provides improved processes for the synthesis of eribulin intermediate, which generally comprise the steps of: a) De-protecting the eribulin-enone (compound 1) in tetrahydrofuran by using TBAF solution, buffered with imidazole HCl in the presence of molecular sieve and sodium sulphate to get an insitu mixture of eribulin-dione diastereomer at C12 carbon (compound 2). Then ketalization may be performed of eribulin-dione insitu intermediate containing mixture of diastereomer at C12 carbon (compound 2) with PPTS in dichloromethane to yield eribulin-diol (compound 3).

Abstract: Methods for preparing degarelix acetate are provided that include the steps of providing a suitable resin; deprotecting the resin with a diethylenetriamine solution; reacting sequentially the deprotected resin with different Fmoc protected amino acids; deprotecting the amino acid in each sequence with a diethylenetriamine solution in a stepwise fashion to yield a degarelix crude compound; and purifying the degarelix crude compound to yield pharmaceutically acceptable degarelix acetate. Methods of preparing degarelix acetate-mannitol premix and the resulting degarelix acetate-mannitol premix are also provided.

Abstract: A process for the preparation of hydroxocobalamin hydrochloride. More particularly the present application relates to improved process for the preparation of Hydroxocobalamin hydrochloride. In addition the present application also relates to process for the preparation of novel amorphous form. This application particularly relates to a process for the industrial manufacture of hydroxocobalamin hydrochloride from cyanocobalamin. The present application also relates to the improvement in yield with better purity of Hydroxocobalamin hydrochloride.

Abstract: A stable, ready-to-use injectable solution including thiotepa and one or more pharmaceutically acceptable solvents, co-solvents, and/or solubilizing agents. Formulations retain at least 90% and as high as 99% of the purity of thiotepa as measured by HPLC after storage at 25° C./60% RH for a period of 7 days. Certain formulations retain at least 99% of the purity of thiotepa as measured by HPLC after storage for at least six months at 2-8° C.

Abstract: The present application provides method for producing methylene blue that includes the steps of providing a reaction mixture having one or more methylene blue intermediates; precipitating metal from the reaction mixture; and producing therefrom crude methylene blue. The crude may further be purified, resulting in methylene compounds having low impurities, preferably having a purity greater than about 97%, having Azure B impurity no greater than 2.5%, and/or a total metal content no greater than 77 ppm. Formulations containing such compounds are also provided.

Abstract: The present application provides method for formulating and corresponding liquid parenteral formulations that include a desired amount of acyclovir sodium added to a vessel with a pharmaceutically acceptable infusion diluent, which are stirred to provide a shelf stable injectable solution.

Abstract: The present application provides method for formulating and corresponding a ready-to-use liquid injectable parenteral pharmaceutical composition, comprising Micafungin sodium and a first excipient and/or pharmaceutically acceptable second excipient.

Abstract: Ready-to-use liquid parenteral formulations are provided that include trabectedin, at least one of a pharmaceutically acceptable solvent, and at least one pharmaceutically acceptable excipient or adjuvant.

Abstract: Method are provided for obtaining ferric citrate that includes the step(s) of reacting ferric chloride with a suitable base to obtain ferric hydroxide; reacting the ferric hydroxide with citric acid to obtain ferric citrate; and processing the ferric citrate to obtain ferric citrate. The resulting ferric citrate has a specific surface area greater than 16 sq. m/g, but less than 20 sq. m/g.

Abstract: The present application provides processes for the purification of ferric carboxymaltose, the process includes the steps of dissolving crude ferric carboxymaltose in a first solvent; charging the ferric carboxymaltose solution in a reaction vessel with a second solvent and precipitating therefrom a ferric carboxymaltose precipitate; and isolating pure ferric carboxymaltose from the ferric carboxymaltose precipitate.

Abstract: The present application provides methods for the synthesis of intermediates in the synthesis of Safinamide or a pharmaceutically acceptable salt thereof herein Safinamide Mesylate, that is substantially free of impurities.

Abstract: A process for the preparation of hydroxocobalamin hydrochloride. More particularly the present application relates to improved process for the preparation of Hydroxocobalamin hydrochloride. In addition the present application also relates to process for the preparation of novel amorphous form. This application particularly relates to a process for the industrial manufacture of hydroxocobalamin hydrochloride from cyanocobalamin. The present application also relates to the improvement in yield with better purity of Hydroxocobalamin hydrochloride.

Abstract: Liquid parenteral formulations are provided that include tigecycline and at least one or more pharmaceutically acceptable excipient or adjuvant, where the formulation is ready to use without additional steps for reconstitution at the time of administration.

Abstract: The present application provides stable ready-to-use injectable formulations of melphalan, methods for preparing storage-stable, ready-to-use injectable formulations that include melphalan, which are easy to administer without need of any reconstitution step and has a desirable solubility, stability, and safety profile. In other embodiments, provided are storage-stable, ready-to-use, injectable liquid parenteral formulations that include melphalan and other pharmaceutically acceptable excipients.

Abstract: Novel processes for making the N-pyrrazole substituted 2-adenosine derivative regadenoson and a novel polymorph thereof. The novel polymorph of regadenoson designated form H and drug substances and pharmaceutical compositions including the novel polymorph H are disclosed.