New Delhi: Glenmark Pharmaceuticals Europe Ltd has received approval for an inhaled respiratory product in Nordic countries, including Sweden, Denmark, Norway, Finland, and Iceland.
The company “has successfully closed the decentralized registration procedure for generic Seretide Accuhaler in the Nordic region”, Glenmark Pharma said in BSE filing.
“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 commercialization 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 S.A. to develop and market a generic version of GlaxoSmithKline’s Seretide Accuhaler product – Fluticasone/Salmeterol dry powder Inhaler in Europe.
Glenmark Pharmaceuticals Chairman & MD Glenn Saldanha 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 3 pharmaceutical brands in Europe with sales of $1.1 billion as per IMS.