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Analog Pharma und Dipharma geben die Genehmigung der US FDA für einen abgekürzten Antrag auf ein neues Medikament (ANDA) für generische Nitisinon-Kapseln (temperaturstabil) bekannt
Rosemont, PA and Chiasso, Switzerland, June 21st, 2022 – Analog Pharma (“Analog”) and Dipharma S.A. (“Dipharma”) today announced that their nitisinone abbreviated new drug application (ANDA) has received final approval from the U.S. Food and Drug ...
Miglustat Dipharma ist jetzt in der Schweiz erhältlich
Chiasso, Switzerland, February 16th, 2021 – Swiss-based Dipharma S.A. (“Dipharma”) today announced that its proprietary product Miglustat Dipharma 100 mg capsules is now available in Switzerland. Miglustat Dipharma, a generic equivalent to Actelio...
Dipharma SA gibt bekannt, dass die FDA den Antrag auf das abgekürzte Zulassungsverfahren (ANDA) für das generische Nitisinon zur Prüfung angenommen hat.
Chiasso, Switzerland, January 24th, 2019 – Dipharma S.A. (“Dipharma”) today announced that the U.S. Food and Drug Administration (FDA) accepted its nitisinone abbreviated new drug application (ANDA) for review. Nitisinone is a generic equivalent t...
Dipharma SA gibt die Erteilung der zentralen Marktzulassung für das generische Miglustat in Europa bekannt
Chiasso, Switzerland, February 20th, 2019 – – Dipharma S.A. (“Dipharma”) today announced that the European Commission has granted Marketing Authorization of its generic Miglustat. This authorization comes after CHMP positive opinion last December ...
Press
Amerigen und Dipharma SA geben die Zulassung durch die U. S. FDA für das generische Miglustat 100 mg Kapseln bekannt.
The first generic version of Miglustat is now approved in the U.S. Lyndhurst, N.J. and Chiasso, Switzerland. April 18th, 2018 – Amerigen Pharmaceuticals Limited (“Amerigen”) and Dipharma S.A. (“Dipharma”) today announced that Amerigen’s Abbr...
Dipharma SA gibt die Validierung des Antrags auf Marktzulassung von Disanit® (Nitisinon) in Europa bekannt.
The first stable capsule formulation of Nitisinone for the treatment of hereditary Tyrosinemia type-1 (HT-1) is now under marketing authorization (MA) evaluation in the EU. Chiasso, Switzerland, February 23rd, 2017 – Dipharma S.A. announces the va...
Dipharma SA und Alvogen geben die Markteinführung von Diterin® 100 mg Tabletten in Südkorea bekannt
First drug now registered and commercially available in the Republic of South Korea for the treatment of Hyperphenylalaninemia (HPA) due to Phenylketonuria (PKU). Chiasso, Switzerland and Seoul, South Korea, February 3rd, 2017 – Dipharma S.A. and ...
