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Carglumic acid is used in the management of rare, life-threatening inborn metabolic disorders affecting the urea cycle.
Dipharma S.A., a Swiss pharmaceutical company specialized in developing medicines for rare diseases, announced that it has developed a new, fast-dissolving formulation of carglumic acid tablets that are stable at room temperature. Carglumic acid is used in the management of rare, life-threatening inborn metabolic disorders affecting the urea cycle.
Dipharma has filed a patent application for its new fast dissolving and stable tablet formulations of carglumic acid, together with the proprietary technology developed to improve the product stability, without modifying the pharmaceutical dosage form.
Carglumic acid formulation will be the fourth commercialized product from the company. Diterin (sapropterin dihydrochloride 100 mg tabs) has already been approved in South Korea and Russia for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU); Miglustat (miglustat 100 mg caps) was submitted to FDA through an abbreviated new drug application (ANDA) in 2016 for the treatment of Gaucher disease; and Disanit (nitisinone capsules) was submitted to EMA in the last quarter of 2016 for the treatment of hereditary tyrosinemia type I.
Dipharma is also developing other products for the treatment of rare metabolic diseases.