Glenmark gets approval for generic Seretide inhaler in Nordic region
Regulatory approval for the generic version of GlaxoSmithKline’s Seretide Accuhaler in the Nordic region is Glenmark’s first inhaled respiratory product approval in Europe
Mumbai: Glenmark Pharmaceuticals Ltd said on Friday that it has received regulatory approval for the generic version of GlaxoSmithKline Plc’s Seretide Accuhaler in the Nordic region, which includes Sweden, Denmark, Norway, Finland and Iceland.
“Glenmark has successfully closed the decentralised registration procedure for generic Seretide Accuhaler in the Nordic region. This will be Glenmark’s first inhaled respiratory product approval in Europe,” the company said in a press release.
The company is now awaiting substitution and pricing approvals and will commercialize the product soon.
In 2015, Glenmark had entered into a strategic development and licensing agreement with Celon Pharma SA to develop and market a generic version of Seretide Accuhaler, which is a dry powder inhaler containing combination fluticasone and salmeterol, in Europe.
Under the pact, Glenmark has semi-exclusive marketing and distribution rights for the product across 15 European countries.
The fluticasone and salmeterol dry powder inhaler is a combination product for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
“Our successful registration closure of a complex respiratory product like fluticasone/salmeterol dry powder inhaler (DPI) in a developed market reinforces Glenmark’s capability and determination towards the respiratory segment. We will continue to work in the area of respiratory, especially devices, in Europe and continue to launch products in future,” Glenn Saldanha, chairman and managing director of the company, said.
On Friday, shares of Glenmark closed 1.77% lower at Rs554.75 on the BSE, while the benchmark Sensex ended down 0.95% at 32,832.94 points.