Glenmark secures marketing authorization for its generic version of Seretide® Accuhaler® in Germany
Posted on September 11, 2018
Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, announced today that its subsidiary Glenmark Arzneimittel GmbH has secured marketing authorization in Germany for Fluticasone/Salmeterol dry powder inhaler (DPI), a generic version of GlaxoSmithKline’s Seretide® Accuhaler®.
Fluticasone/Salmeterol DPI is a combination product for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Glenmark will sell the product in Germany under the name “SALFLUTIN”.
“This approval validates Glenmark’s capabilities in the complex inhaled respiratory products segment. Upon launch, generic Fluticasone/Salmeterol DPI will be Glenmark’s first inhalation product available in Germany. There is huge potential for the product in Germany and we are optimistic that it will help enhance growth of the European business,” said Achin Gupta, Executive Vice President & Business Head of Europe and Latin America, Glenmark Pharmaceuticals.
Glenmark had entered into a strategic development and licensing agreement with Celon Pharma S.A. (Celon) in 2015 to develop and market generic Fluticasone/Salmeterol DPI in 15 European countries.
The company has already launched this product in Denmark, Sweden and Norway.
According to IQVIA data, Fluticasone/Salmeterol dry powder inhaler (DPI) had sales of USD 844 million in Europe in the 12 month period ended March 2018.
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