SAVA Healthcare Secures CDSCO Approval for Nasal Spray Targeting Allergic Rhinitis with Congestion
- SAVA received first DCGI approval for a combination nasal spray.
- Designed for targeted relief of allergy-induced nasal symptoms, including inflammation and congestion.
Pune, 12 June 2025: SAVA Healthcare Limited, a leading contract development and manufacturing organization (CDMO) in the Indian pharmaceutical sector, has announced that it 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.
Aniruddha Rajurkar, CEO, SAVA Healthcare Limited, said: “This DCGI approval marks a significant milestone in our R&D formulation journey. It reflects our commitment to strive for innovation, regulatory excellence, and high-quality manufacturing. This approval further enhances our position as a reliable CDMO partner, strengthening SAVA’s domestic and global partnerships, particularly in the respiratory therapeutics segment, where patient demand for non-invasive and rapid-relief solutions is growing steadily.”
Known for its robust R&D pipeline and international footprint, SAVA Healthcare Limited continues to expand its portfolio in regulated and semi-regulated markets. The company’s expertise spans multiple therapeutic segments, with a special focus on respiratory care, dermatology, ophthalmology, and animal health.
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.
SAVA Healthcare is a trusted manufacturing partner to top Indian pharmaceutical companies, such as, Dr. Reddys’ Laboratory, Sun Pharma, Abbott, Lupin, Zydus, etc. and has a global footprint with exports of pharmaceutical products to more than 50 countries including Canada, Ukraine, the CIS, Asia and Africa (especially FWA – French West Africa).
About SAVA Healthcare:
SAVA Healthcare Limited, headquartered in India, operates a Health Canada and PIC/s certified manufacturing facility in Gujarat, alongside an advanced R&D centre in Pune. The company is organized into four key sectors: International Business, Contract Research & Manufacturing Services (CRAMS), Companion Animal (CA) Healthcare, and Farm Animal (FA) Healthcare, as well as a specialized division, SAVA Herbals. Its International Business division extends SAVA’s reach globally, distributing both human and veterinary pharmaceuticals across North America, Central America, Asia, Africa, and the CIS countries.
Renowned for its expertise in Nasal Drug Delivery Platforms, SAVA’s CRAMS division has established itself as a reliable partner, catering to a diverse clientele of Indian and international companies. This commitment to quality and innovation positions SAVA Healthcare as a prominent player in the pharmaceutical industry.
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For further queries, contact:
Name: Neha Rai | Email: neha.rai@savaglobal.com | Mobile: +91 99879 22230