Glenmark Pharmaceuticals announced that its wholly-owned subsidiary, Glenmark Specialty S.A. (Switzerland), received a United States Food & Drug Administration (FDA) approval for its New Drug Application (NDA), Ryaltris nasal spray.
Ryaltris is a nasal spray used in the treatment of symptoms of seasonal allergic Rhinitis in adults and pediatric patients 12 years of age and older in the United States. The recommended daily dose for Ryaltris is two sprays in each nostril twice daily.
Ryaltris will be marketed and distributed in the United States (US) by Hikma Specialty U.S.A., Inc., as part of its exclusive licensing agreement with Glenmark Specialty S.A (Switzerland).
Ryaltris has been approved and is marketed in Australia, the Czech Republic, Poland, Russia, South Africa, Ukraine, the United Kingdom, and Uzbekistan. In April 2021, Glenmark Pharmaceuticals concluded the DCP regulatory procedure in Europe, enabling approval in 17 countries across EU and UK.
The pharmaceutical major has entered into commercial agreements with several partners around the world, including Menarini for the commercialization of Ryaltris in select EU markets, and with Bausch Health in Canada (where it is under review by Health Canada).
The drug company posted a 10.1% increase in consolidated net profit to Rs 257.66 crore on a 7.5% rise in net sales to Rs 3,125.43 crore in Q2 FY22 over Q2 FY21.
Shares of Glenmark Pharmaceuticals rose 1.23% to close at Rs 521.55 yesterday, 14 January 2022. Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and over-the-counter (OTC) business with operations in over 50 countries.
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