Year-End Cheer For Glenmark As Ryaltris To Debut In Australia
Glenmark is ending 2019 on a buoyant note, with its rhinitis therapy getting the go-ahead in Australia. Though not seen as a huge commercial opportunity in the island continent, the clearance augurs well for the product’s overall trajectory.
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Glenmark expects its first US manufacturing site to go commercial next year, accelerating growth in that market, while it sets right certain compliance blips back home. The Indian firm is also on course to divest certain non-core assets but notes that bringing in a minority partner for its API unit is not a priority.
Firm should have addressed complaints of gritty topicals and compromised container/closures, and its own findings about overheated creams, the US FDA says.
India's Glenmark gets US Complete Response Letter for Ryaltris but emphasizes the FDA hasn’t faulted the clinical data for the product, and that the action won’t impact recent alliances for the rhinitis asset.