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Dipharma SA
21 June 2022

Analog Pharma and Dipharma announce US FDA approval of abbreviated new drug application (ANDA) of generic Nitisinone capsules (temperature stable)

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 ...
Press
Dipharma SA
16 February 2021

Miglustat Dipharma is now available in Switzerland

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...
Press
Dipharma SA
20 February 2019

Dipharma announces grant of centralised marketing authorization for generic Miglustat in Europe

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
Dipharma SA
18 April 2018

Amerigen and Dipharma announce U.S. FDA approval for generic MIGLUSTAT 100 mg capsules

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...
Press
Dipharma SA
23 February 2017

Dipharma announces the validation of DISANIT® (NITISINONE) marketing authorization application in Europe

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...
Press
Dipharma SA
3 February 2017

DIPHARMA and ALVOGEN announce launch of Diterin® 100mg tablets in South Korea

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 ...
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