Good News! L-Malic Acid API from Shijiazhuang Sihua Pharmaceutical Group Has Been Approved


发布时间:2023-04-28

【概要描述】 In the fragrant month of April, innovation at Shijiazhuang Sihua Pharmaceutical Group is blooming in a particularly vibrant hue. On April 28, L-malic acid, submitted by the group’s Hebei Guolong Pharmaceutical Co., Ltd., was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms.
In the fragrant month of April, innovation at Shijiazhuang Sihua Pharmaceutical Group is blooming in a particularly vibrant hue. On April 28, L-malic acid, submitted by the group’s Hebei Guolong Pharmaceutical Co., Ltd., was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms.
According to reports, the L-malic acid API approved this time is the group’s sixth new product to receive approval in April, and also the fifth API variety approved by the group this year, following tinidazole, doxofylline, theobromine, and tedizolid phosphate.
According to available information, L-malic acid serves as the active pharmaceutical ingredient in Compound Electrolyte Injection (II), which is indicated for the treatment of acidosis-associated dehydration and for replenishing extracellular fluid; it is also incorporated into compound amino acid injection, intended for postoperative patients who are debilitated or have hepatic dysfunction, to enhance the bioavailability of amino acids. In addition, L-malic acid is used in various tablet formulations to impart a fruity flavor and to facilitate its absorption and distribution within the body.
 

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