End-to-End CDMO Services for Nasal Spray Development and Manufacturing
At Basic Pharma, we specialize in the pharmaceutical development and GMP manufacturing of nasal spray products, offering fully integrated CDMO services for both generic and innovative non-pressurized nasal drug delivery systems. Our expertise ensures compliance with global regulatory standards, helping you bring high-quality nasal sprays to market efficiently.
Scientific expertise across nasal spray formulations
Self- or co-developed products
From over the counter (OTC) decongestants to prescription corticosteroids and combination therapies, Basic Pharma provides end-to-end support, including formulation development (both solutions and suspensions), packaging development, analytical method development and validation, process scale-up and GMP manufacturing, and in vitro bioequivalence studies
Proven expertise with key APIs
Basic Pharma has proven expertise with key APIs such as Xylometazoline, a widely used topical decongestant for relief of nasal congestion, and Mometasone Furoate, Fluticasone Propionate, Fluticasone Furoate, corticosteroids used in the treatment of allergic rhinitis and other nasal inflammatory conditions, with or without Azelastine as a combination therapy used for seasonal allergic rhinitis, offering anti-inflammatory and antihistamine properties in one formulation.
Self- or co-developed products
Securing bioequivalence and regulatory approval for a generic nasal spray requires strategic insight. Our end-to-end development services are designed to de-risk your program, accelerate your path to market, and optimize your total investment. We provide the critical guidance to determine what is needed and what may be justified, reducing overall project investment.
Our proven expertise covers all key performance indicators, required to ensure product performance, safety, and quality. Our in-house experts leverage advanced analytical capabilities to optimize your product's critical behaviours and comprehensive understanding of the requirements for a successful development.
From solutions to suspensions, our development process is built on a comprehensive evaluation of all Critical Quality Attributes to ensure our products meet the most stringent regulatory standards in EU and abroad.
Get in touch to discuss your specific requirements
Advanced analytical development and validation
Our analytical development team ensures robust testing and compliance with EMA, ICH, and global guidelines, and has a track record for developing and validating non-pharmacopeial methods on complex final formulations using HPLC-PI, HPLC-RI, and UV/VIS. In addition we perform in-use and ongoing (through shelf-life) stability studies in house, with our newly built climate chambers set to both climatic zone II, zone IVa and IVb.
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, including:
• 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 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 optimized for sterile and non-sterile products. 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.
The Basic Pharma Advantage
At Basic Pharma, we understand that every nasal spray development project comes with unique challenges. That’s why we offer tailored solutions to support you from concept to commercial launch.
Need a reliable nasal spray CDMO?
We provide full-service development and regulatory support — from formulation and analytical method development to dossier preparation and GMP manufacturing.
Developing a generic product?
Our extensive experience in nasal spray solutions and suspensions ensures a streamlined path to bioequivalence and market approval.
Expanding into new markets?
We offer commercial scale-up, GMP-compliant production, and global launch planning to help you successfully expand your product portfolio worldwide.
Bring your nasal spray to market with confidence
Partner with Basic Pharma — your trusted CDMO for efficient, end-to-end nasal spray development and manufacturing. With our scientific expertise, state-of-the-art infrastructure, and agile approach, we transform your concept into a commercially successful, high-quality nasal spray product.
