Therapeutic Area
Respiratory CDMOs
Compare CDMOs with respiratory drug manufacturing expertise for metered-dose inhalers, dry powder inhalers, nebulizer solutions, and nasal sprays. Filter by device type, scale, and certifications.
110 companies listed
About Respiratory Drug Manufacturing
Respiratory drug manufacturing is device-intensive. The active ingredient is only half the product -- the delivery device (metered-dose inhaler, dry powder inhaler, soft mist inhaler, nebulizer) determines drug deposition in the lungs and ultimately clinical efficacy. CDMOs in this space need both pharmaceutical formulation expertise and device/packaging engineering capabilities.
Particle engineering is the critical science. Inhaled drugs require precisely controlled particle size distributions (typically 1-5 microns for deep lung delivery). Micronization, spray drying, and engineered particle technologies determine the respirable fraction. CDMOs should demonstrate particle size control via laser diffraction (Malvern), cascade impaction (NGI), and delivered dose uniformity testing across the product lifecycle.
Combination products add regulatory complexity. Inhalers are regulated as drug-device combination products by the FDA (21 CFR Part 4) and require both pharmaceutical cGMP and device quality system (ISO 13485) compliance. The CDMO must manage two quality systems simultaneously. For generic inhalers, demonstrating bioequivalence requires in vitro similarity studies (aerodynamic particle size distribution, delivered dose uniformity) and often in vivo pharmacokinetic studies.
Companies (110)
Vetter Pharma
Germany
Vetter Pharma is a leading global Contract Development and Manufacturing Organization specializing in aseptic fill-and-finish services for injectable drug products. Headquartered in Ravensburg, Germany, Vetter operates as an independent, family-owned business with over 75 years of experience.
Biologics Drug ProductFill/Finish (Vials)Fill/Finish (Syringes)
BioInnovatise, Inc.
United States
BioInnovatise is a US-based CDMO specializing in quick-turnaround molecular biology services for early-stage drug discovery. Services include plasmid DNA services, viral vector packaging, and CRISPR-Cas9 services. The company collaborates with researchers in government, academia, and industry, focusing on custom cloning and the early discovery phase of drug development.
Viral Vectors
Frequently Asked Questions
What device manufacturing capabilities should a respiratory CDMO have?+
Key capabilities include: metered-dose inhaler (MDI) formulation and filling (propellant-based systems, valve crimping), dry powder inhaler (DPI) formulation (carrier-based and engineered particle systems), nebulizer solution manufacturing (sterile or non-sterile), device component molding or sourcing, assembly line integration, and combination product testing (dose content uniformity, aerodynamic particle size distribution via cascade impaction). ISO 13485 certification is essential for the device component.
Why is particle size so critical for inhaled drugs?+
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