Glenmark Pharmaceuticals Europe (Glenmark) has successfully closed the Decentralised Registration Procedure (DCP) for generic Seretide Accuhaler in the Nordic region, including Sweden, Denmark, Norway, Finland and Iceland. This will be Glenmark’s 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.
Glenmark had entered into a Strategic Development & Licensing Agreement with Celon Pharma S.A. (Celon) to develop and market a generic version of GlaxoSmithKline’s Seretide Accuhaler product - Fluticasone / Salmeterol dry powder Inhaler in Europe. This is the first approval from the deal, and marks the entry of Glenmark in the Respiratory Generic segment.
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.
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| Zydus Lifesciences | 938.90 |
| Lupin | 2377.90 |
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