Nasal Spray Development and Manufacturing

Specializing in the pharmaceutical development and GMP manufacturing of nasal spray products, we offer fully integrated CDMO services for both generic and innovative non‑pressurized nasal drug delivery systems. With comprehensive in‑house capabilities spanning formulation, analytical development, process optimization, and commercial-scale production, our team ensures full compliance with global regulatory standards. This enables faster, reliable, and high‑quality pathways to market for your nasal spray products.

Nasal Spray

Proven Expertise in Nasal API Formulation

We have extensive experience in developing and manufacturing nasal spray formulations with a broad range of key APIs. This proven track record ensures robust development, optimized performance, and reliable manufacturing of both single‑API and combination nasal spray products. Our expertise covers:

  • Xylometazoline – A widely used topical decongestant that provides fast and effective relief of nasal congestion
  • Mometasone Furoate, Fluticasone Propionate and Fluticasone Furoate – Potent corticosteroids for the treatment of allergic rhinitis and other inflammatory nasal conditions
  • Fluticasone + Azelastine – A combination therapy offering both anti‑inflammatory and antihistamine effects, providing comprehensive relief for seasonal allergic rhinitis
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Critical Quality Attributes for Generic Nasal Sprays

Our Analytical Development team ensures robust testing and full compliance with EMA, ICH, and global guidelines. We provide comprehensive in-house testing of all critical quality attributes for generic nasal sprays.

  • Qualitative and Quantitative Composition
  • Actuation Volume
  • Single Actuation Content / Mass of Single Dose
  • Droplet Size Distribution
  • Mass of Droplets (<10 µm)
  • Minimum Fill Justification
  • Extractables and Leachables
  • Particle Size Distribution
  • Spray Pattern
  • Plume Angle and Plume Geometry
  • Rheological properties (e.g. thixotrophy, viscosity)
  • Surface Tension
  • pH, Density, Osmolality
  • Buffer Capacity
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Why choose Basic Pharma for nasal spray CDMO services?

We offer a full suite of end-to-end CDMO capabilities for nasal spray drug products.

  • Formulation Development

    Expertise in nasal spray solutions, suspensions, and emulsion-based delivery systems. Our team develops and optimizes formulations with a focus on in vitro bioequivalence (IVBE) study requirements, physical and chemical stability, and regulatory compliance in line with current European and overseas guidelines.

  • Analytical Method Development

    A dedicated analytical development team supports method validation and stability studies, ensuring compliance with EMA, and ICH guidelines. We provide in vitro bioavailability (IVBA) testing, nasal spray droplet size distribution, spray pattern analysis, and plume geometry testing.

  • Nitrosamine Risk Assessment

    Our development process includes thorough nitrosamine risk mitigation, aligned with the latest regulatory expectations, ensuring your product meets the strictest global safety standards.

  • Scale-Up & GMP Manufacturing

    From pilot batches to full commercial scale, we offer GMP-compliant manufacturing with nasal spray filling and packaging lines. We also provide technical transfer support and market launch readiness.

  • Regulatory & Market Expansion Support

    Our regulatory affairs team provides expert guidance in dossier compilation, variation filing, and CTD Module 3 preparation, supporting your product’s approval across multiple territories.

  • In-Use Stability Studies

    We also conduct comprehensive in-use stability studies, long-term shelf-life stability studies, and forced‑degradation experiments to support fully ICH‑compliant stability programs. Our facilities include climate chambers covering Zones II, III, IVa, and IVb.