The present invention discloses pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical-grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.

The present invention discloses pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical-grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.

A process for production of malic acid includes obtaining a feed that includes one or more of crude maleic anhydride, pure maleic anhydride, crude maleic acid, crude fumaric acid, pure maleic acid, pure fumaric acid, vent gas scrubber solutions from production of maleic anhydride, and vent gas scrubber solutions from production of phthalic anhydride. The feed is passed in a tubular reactor assembly to obtain a first product stream, which includes unreacted feed and malic acid. The feed is made to undergo hydration reaction in the tubular reactor assembly for a first predetermined time period, and further hydration of the first product stream is caused in a stirred tank reactor assembly for a second predetermined time period to obtain a final product stream, which includes the malic acid.

A process for production of malic acid includes obtaining a feed that includes one or more of crude maleic anhydride, pure maleic anhydride, crude maleic acid, crude fumaric acid, pure maleic acid, pure fumaric acid, vent gas scrubber solutions from production of maleic anhydride, and vent gas scrubber solutions from production of phthalic anhydride. The feed is passed in a tubular reactor assembly to obtain a first product stream, which includes unreacted feed and malic acid. The feed is made to undergo hydration reaction in the tubular reactor assembly for a first predetermined time period, and further hydration of the first product stream is caused in a stirred tank reactor assembly for a second predetermined time period to obtain a final product stream, which includes the malic acid.

The present invention belongs to the pharmaceutical field, and provides the pharmaceutically acceptable salts of the compound (S)-7-(4-(1-(methylsulfonyl)piperidin-4-yl)phenyl)-N-(morpholin-2-ylmethyl)pyrido[3,4-b]pyrazin-5-amine and the crystalline forms thereof, the solvates and the crystalline forms thereof, the pharmaceutical compositions comprising the same as well as the methods of preparing the same and the use thereof.

The present invention relates to novel hydroxyl compounds, compositions comprising hydroxyl compounds, and methods useful for treating and preventing a variety of diseases and conditions such as, but not limited to aging, Alzheimer's Disease, cancer, cardiovascular disease, diabetic nephropathy, diabetic retinopathy, a disorder of glucose metabolism, dyslipidemia, dyslipoproteinemia, hypertension, impotence, inflammation, insulin resistance, lipid elimination in bile, obesity, oxysterol elimination in bile, pancreatitis, pancreatitius, Parkinson's disease, a peroxisome proliferator activated receptor-associated disorder, phospholipid elimination in bile, renal disease, septicemia, metabolic syndrome disorders (e.g., Syndrome X), thrombotic disorder. Compounds and methods of the invention can also be used to modulate C reactive protein or enhance bile production in a patient. In certain embodiments, the compounds, compositions, and methods of the invention are useful in combination therapy with other therapeutics, such as hypocholesterolemic and hypoglycemic agents.

The present invention relates to novel hydroxyl compounds, compositions comprising hydroxyl compounds, and methods useful for treating and preventing a variety of diseases and conditions such as, but not limited to aging, Alzheimer's Disease, cancer, cardiovascular disease, diabetic nephropathy, diabetic retinopathy, a disorder of glucose metabolism, dyslipidemia, dyslipoproteinemia, hypertension, impotence, inflammation, insulin resistance, lipid elimination in bile, obesity, oxysterol elimination in bile, pancreatitis, pancreatitius, Parkinson's disease, a peroxisome proliferator activated receptor-associated disorder, phospholipid elimination in bile, renal disease, septicemia, metabolic syndrome disorders (e.g., Syndrome X), thrombotic disorder. Compounds and methods of the invention can also be used to modulate C reactive protein or enhance bile production in a patient. In certain embodiments, the compounds, compositions, and methods of the invention are useful in combination therapy with other therapeutics, such as hypocholesterolemic and hypoglycemic agents.

Preparation and characterization of novel tamibarotene forms suitable for pharmaceutical compositions in drug delivery systems for the treatment of cancer stem cells. The tamibarotene compositions can be used for the safe and effective treatment of human diseases including a variety of cancers, cancer stem cells, drug resistant cancers, and used as a radio sensitizer.

Preparation and characterization of novel tamibarotene forms suitable for pharmaceutical compositions in drug delivery systems for the treatment of cancer stem cells. The tamibarotene compositions can be used for the safe and effective treatment of human diseases including a variety of cancers, cancer stem cells, drug resistant cancers, and used as a radio sensitizer.

The present invention relates to salt forms of the hematopoietic progenitor kinase 1 (HPK1) inhibitors N-(2-((2S,4S)-4-Amino-2-(hydroxymethyl)pyrrolidin-1-yl)-5-fluorophenyl)-2-(2-fluoro-6-methoxyphenyl)pyrimidine-4-carboxamide and N-(2-((2S,4S)-4-Amino-2-(hydroxymethyl)pyrrolidin-1-yl)-4-(4-cyanopyridin-3-yl)phenyl)-2-(2-fluoro-6-methoxyphenyl)pyrimidine-4-carboxamide, including methods of preparation thereof, where the compounds are useful in the treatment of HPK1 mediated diseases such as cancer.