SAVA Healthcare Limited, a leading contract development and manufacturing organization (CDMO) in the Indian pharmaceutical sector, has received its first drug approval from the Drug Controller General of India (DCGI) for a combination nasal spray indicated for the treatment of allergic rhinitis with nasal congestion.
The approved formulation contains Fluticasone Furoate (27.5 mcg) and Oxymetazoline Hydrochloride (50 mcg) and is designed for targeted relief of allergy-induced nasal symptoms, including inflammation and congestion.
The product will be manufactured at SAVA Healthcare’s state-of-the-art facility in Surendranagar, Gujarat, which complies with stringent regulatory requirements and quality standards.
Packaged in high-density polyethylene (HDPE) bottles equipped with a metered spray pump, the nasal spray ensures precise dosing and user-friendly administration. This formulation combines the anti-inflammatory properties of fluticasone, a corticosteroid, with the decongestant effect of oxymetazoline, offering comprehensive symptomatic relief for patients suffering from seasonal and perennial allergic rhinitis.
All regulatory and technical prerequisites laid out by the Central Drugs Standard Control Organisation (CDSCO) were met during the approval process, highlighting SAVA Healthcare’s growing competency in complex formulations and respiratory drug delivery systems.
With the launch of this formulation, SAVA Healthcare not only enters a new product category under its own license but also sets the stage for future filings and tech transfers in the complex nasal spray segment, both for India and international markets.
