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)
R
Reig Jofre
Spain
Reig Jofre (Laboratorio Reig Jofre, S.A.) is a Spanish pharmaceutical company founded in 1929 that operates both as a pharmaceutical company with its own products and as a CDMO. They have four development and production centres in Europe (two in Toledo, one in Barcelona, one in Sweden) with over 1,100 employees. Their CDMO capabilities include sterile lyophilizates, sterile liquids, non-sterile liquids, and beta-lactam manufacturing. Known for excellence in freeze-drying technology and advanced sterile manufacturing. FDA-registered with manufacturing and analysis operations, though regulatory history shows 3 OAI inspections.
Small Molecule Drug ProductOral Solid DoseFormulation Development
CSL (incl. CSL Behring)
Australia
CSL is a global biotechnology company headquartered in Melbourne, Australia, operating through CSL Behring, CSL Seqirus, and CSL Vifor. The company specializes in plasma-derived biotherapies for rare and serious diseases including bleeding disorders and immunodeficiencies, vaccines, and iron deficiency treatments, but operates as an integrated developer/manufacturer for its own products rather than as a CDMO offering contract services to external clients.
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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