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Glenmark closes decentralised registration procedure for generic Seretide Accuhaler in Nordic region

Our Bureau, Mumbai
Friday, December 1, 2017, 16:20 Hrs  [IST]

Glenmark Pharmaceuticals Europe has successfully closed the decentralised registration procedure for generic Seretide Accuhaler in the Nordic region, including Sweden, Denmark, Norway, Finland and Iceland. This will be its first inhaled respiratory product approval in Europe, and re-enforces Glenmark's commitment in the respiratory area. The commercialization of the product would depend on national approval as well as substitution and pricing approvals.

It had entered into a strategic development & 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. This the first approval from the deal, and marks the entry of Glenmark in the respiratory generic segment.

Glenn Saldanha, chairman and MD, said, “Our successful registration closure of a complex respiratory product like fluticasone/salmeterol dry powder inhaler (DPI) in a developed market re-enforces Glenmark's capability and determination towards the respiratory segment. This continues to emphasize Glenmark's focus in this complex product segment and in Europe. 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 US$ 1.1 billion as per IMS.

Celon Pharma S A is an integrated pharma company which conducts advanced research and manufactures modoern drugs. It has two fully equipped laboratories, dedicated to research and development of medicinal products, both generic and innovative.

 

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