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.
50 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 (50)
N
NovaPharma B.V.
Netherlands
NovaPharma B.V. is a leading contract development and manufacturing organization headquartered in Netherlands. We specialize in Commercial Manufacturing, Small Molecule API Manufacturer with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
IGS B.V.
Netherlands
IGS B.V. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
P
Praveen Laboratories Pvt Ltd
India
Praveen Laboratories Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Cleo Singapore
Singapore
Cleo Singapore is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Kekule Pharma Limited
India
Kekule Pharma Limited is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
P
PrimePharma GmbH
Ireland
PrimePharma GmbH is a leading contract development and manufacturing organization headquartered in Ireland. We specialize in Formulation Development, Clinical Trial Materials, Biologics Manufacturer with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
P
PurCell Bio
United States
PurCell Bio is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
C
Caplin Point Laboratories / Caplin Steriles
India
Caplin Point Laboratories / Caplin Steriles is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
A
ApexPharma Corp.
Belgium
ApexPharma Corp. is a leading contract development and manufacturing organization headquartered in Belgium. We specialize in Small Molecule API Manufacturer, Commercial Manufacturing, Packaging with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Centroflora Group
Brazil
Centroflora Group is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Macleods Pharmaceuticals Ltd
India
Macleods Pharmaceuticals Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
R
RNP Pharmachem
India
RNP Pharmachem is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Interos Inc.
France
Interos Inc. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
GL Biochem (Shanghai) Ltd.
China
GL Biochem (Shanghai) Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
CBL Patras S.A.
Greece
CBL Patras S.A. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
LOTTE BIOLOGICS
South Korea
LOTTE BIOLOGICS is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
TekniPlex (TekniPlex Healthcare)
Italy
TekniPlex (TekniPlex Healthcare) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
RENOLIT Healthcare
China
RENOLIT Healthcare is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Laboratorios Salvat, S.A.
Spain
Laboratorios Salvat, S.A. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
E
Elysium Pharmaceuticals Ltd.
India
Elysium Pharmaceuticals Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Douglas CDMO
United Kingdom
Douglas CDMO is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
The Ritedose Corporation
United States
The Ritedose Corporation is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
N
Newland Pharmaceutical Co. Ltd
China
Newland Pharmaceutical Co. Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Oliver Healthcare Packaging
China
Oliver Healthcare Packaging is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
F
FusionPharma B.V.
Germany
FusionPharma B.V. is a leading contract development and manufacturing organization headquartered in Germany. We specialize in Fill/Finish, Packaging with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
V
VanguardTherapeutics LLC
Ireland
VanguardTherapeutics LLC is a leading contract development and manufacturing organization headquartered in Ireland. We specialize in Clinical Trial Materials, Packaging, Cell & Gene Therapy with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
M
MedTherapeutics GmbH
Denmark
MedTherapeutics GmbH is a leading contract development and manufacturing organization headquartered in Denmark. We specialize in Packaging, Formulation Development, Commercial Manufacturing with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
P
PremierTherapeutics Inc.
Spain
PremierTherapeutics Inc. is a leading contract development and manufacturing organization headquartered in Spain. We specialize in Fill/Finish, Cell & Gene Therapy, Biologics Manufacturer with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Lee Pharma Limited
India
Lee Pharma Limited is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
P
Piramal Pharma Limited (Piramal Pharma Solutions)
Canada
Piramal Pharma Limited (Piramal Pharma Solutions) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Fermic
Mexico
Fermic is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Emmennar Pharma Private Limited
India
Emmennar Pharma Private Limited is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
N
Nanjing Lifenergy R&D Co., Ltd.
China
Nanjing Lifenergy R&D Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Flamma Group
China
Flamma Group is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
K
Kirsch Pharma HealthCare
Germany
Kirsch Pharma HealthCare is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Hiral Labs Ltd
India
Hiral Labs Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Landmark Bio
United States
Landmark Bio is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Archimica S.p.A.
Italy
Archimica S.p.A. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Boston Institute of Biotechnology (BIB)
United States
Boston Institute of Biotechnology (BIB) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
GELITA AG
Brazil
GELITA AG is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Honeywell International Inc.
United States
Honeywell International Inc. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Qualiskills / Pharma Pack Hungary Ltd.
Hungary
Qualiskills / Pharma Pack Hungary Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
ExoXpert
Germany
ExoXpert is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
High Force Research Ltd
United Kingdom
High Force Research Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Genevia Lifesciences AG
Switzerland
Genevia Lifesciences AG is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Addii Biotech Pvt Ltd
India
Addii Biotech Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
TAIZHOU YONGFENG CHEMICAL INDUSTRY CO., LTD
China
TAIZHOU YONGFENG CHEMICAL INDUSTRY CO., LTD is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
ACON Pharmaceuticals
United States
ACON Pharmaceuticals is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Instrumex GmbH
Germany
Instrumex GmbH is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Tower Cold Chain
United Kingdom
Tower Cold Chain is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
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?+
Particle size determines where in the respiratory tract the drug deposits. Particles larger than 5 microns deposit in the mouth and throat (local side effects, reduced efficacy). Particles between 1-5 microns reach the lower airways and alveoli (therapeutic target for asthma, COPD). Particles smaller than 0.5 microns may be exhaled without depositing. The respirable fraction (percentage of drug in the 1-5 micron range) directly correlates with clinical efficacy. A CDMO must control this parameter within tight specifications.
Need help finding the right CDMO?
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.