The company added that the commercialisation of the product would depend on national approval as well as substitution and pricing approvals
Glenmark Pharmaceuticals Europe has received approval for an inhaled respiratory product in Nordic countries, including Sweden, Denmark, Norway, Finland and Iceland.
The company ‘has successfully closed the decentralised registration procedure for generic Seretide Accuhaler in the Nordic region’, Glenmark Pharma said in BSE filing today.
“This will be Glenmark’s first inhaled respiratory product approval in Europe, and re-enforces Glenmark’s commitment in the respiratory area,” it said.
The company added that the commercialisation of the product would depend on national approval as well as substitution and pricing approvals.
Glenmark had entered into a strategic development and licensing agreement with Celon Pharma to develop and market a generic version of GlaxoSmithKline’s Seretide Accuhaler product – Fluticasone/Salmeterol dry powder Inhaler in Europe.
Glenn Saldanha, Chairman and MD, Glenmark Pharmaceuticals said, “We will continue to work in the area of respiratory especially devices in Europe and we will continue to launch products in this area in future.”
The Fluticasone/ Salmeterol dry powder inhaler is a combination product for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Seretide marketed by GlaxoSmithKline is among the top three pharmaceutical brands in Europe with sales of $1.1 billion as per IMS.