Nanopharm
Nanopharm Ltd is a contract research and development organisation specialising in orally inhaled and nasal drug products (OINDPs). The company provides end-to-end development support from preclinical formulation and particle engineering through in‑vitro and in‑silico bioequivalence approaches, analytical method development, and cGMP‑compliant clinical supply and batch release. Nanopharm emphasises integrated device–formulation development, advanced aerosol characterisation, and regulatory pathways for alternative bioequivalence.
Industries
Nr. of Employees
small (1-50)
Nanopharm
Patents
Apparatus and method for determination of the fine particle dose of a powder inhalation formulation
US-11181447-B2
View DetailsApparatus and method for determination of the fine particle dose of a powder inhalation formulation
US-10724928-B2
View Details
Apparatus and method for determination of the fine particle dose of a powder inhalation formulation
US-11181447-B2
View DetailsApparatus and method for determination of the fine particle dose of a powder inhalation formulation
US-10724928-B2
View DetailsProducts
Aeronose Nasal CAST
A proprietary in-vitro 3D nasal cavity model co-developed by Aptar Pharma and the University of Tours to assess spray deposition patterns of nasal spray products across different target regions of the nasal cavity.
Clinical Trial Manufacturing (CTM) Support
End-to-end clinical trial material manufacturing support for orally inhaled and nasal drug products (OINDPs), including small-batch cGMP manufacturing, fill and finish services, stability testing, and finished product release testing.
cGMP Analytical Stability Testing
Specialized clinical development services providing stage-appropriate analytical method validations, cGMP clinical trial materials (CTMs) release, and stability testing programs for OINDPs.
Nanopharm Clinical Development Services
Comprehensive clinical development services for inhaled and intranasal drug products, including cGMP manufacturing, fill-finish services, and analytical support.
Analytical Research & Development
Specialized analytical R&D services focused on characterizing active pharmaceutical ingredients, excipients, and device performance for orally inhaled and nasal drug products (OINDPs).
Dry Powder Inhaler Services
Specialized development services for dry powder inhalers covering material characterization, process development, particle engineering, and aerosol testing.
Aeronose Nasal CAST
A proprietary in-vitro 3D nasal cavity model co-developed by Aptar Pharma and the University of Tours to assess spray deposition patterns of nasal spray products across different target regions of the nasal cavity.
Clinical Trial Manufacturing (CTM) Support
End-to-end clinical trial material manufacturing support for orally inhaled and nasal drug products (OINDPs), including small-batch cGMP manufacturing, fill and finish services, stability testing, and finished product release testing.
cGMP Analytical Stability Testing
Specialized clinical development services providing stage-appropriate analytical method validations, cGMP clinical trial materials (CTMs) release, and stability testing programs for OINDPs.
Nanopharm Clinical Development Services
Comprehensive clinical development services for inhaled and intranasal drug products, including cGMP manufacturing, fill-finish services, and analytical support.
Analytical Research & Development
Specialized analytical R&D services focused on characterizing active pharmaceutical ingredients, excipients, and device performance for orally inhaled and nasal drug products (OINDPs).
Dry Powder Inhaler Services
Specialized development services for dry powder inhalers covering material characterization, process development, particle engineering, and aerosol testing.
Services
Feasibility, preformulation, formulation optimisation, device integration and development support through to cGMP readiness and clinical supply.
Analytical method development, validation, cGMP release testing and ICH stability studies for inhaled and nasal products.
Combined laboratory aerosol testing and computational modelling services to simulate regional deposition, dissolution and pharmacokinetics to support alternative bioequivalence approaches.
Regulatory strategy, dossier preparation and Model Master File development to support alternative bioequivalence pathways and regulatory engagement.
cGMP release testing, batch release, ICH stability testing and clinical materials supply including fill–finish services for OINDPs.
Feasibility, preformulation, formulation optimisation, device integration and development support through to cGMP readiness and clinical supply.
Analytical method development, validation, cGMP release testing and ICH stability studies for inhaled and nasal products.
Combined laboratory aerosol testing and computational modelling services to simulate regional deposition, dissolution and pharmacokinetics to support alternative bioequivalence approaches.
Regulatory strategy, dossier preparation and Model Master File development to support alternative bioequivalence pathways and regulatory engagement.
cGMP release testing, batch release, ICH stability testing and clinical materials supply including fill–finish services for OINDPs.
Expertise Areas
- OINDP development and formulation
- In‑vitro and in‑silico bioequivalence approaches
- Aerosol characterisation and inhaler performance testing
- Particle engineering and spray drying
Key Technologies
- Computational fluid dynamics (CFD)
- Physiologically based pharmacokinetic (PBPK) modelling
- Aerodynamic particle size distribution testing (impactor methods)
- Integrated in‑vitro/in‑silico modelling
News & Updates
Press release describing an exclusive collaboration to combine imaging-derived CFD and integrated in‑vitro/in‑silico modelling to support alternative bioequivalence submissions for inhaled products.
Article outlining the use of Model Master Files to reuse validated simulation models and streamline regulatory review for OINDPs.
Announcement of expansion into a larger facility with R&D and cGMP analytical laboratories, and increased particle engineering and spray drying capacity.
Article discussing FDA priorities and the increasing role of modelling and simulation (CFD, PBPK) as alternatives or complements to clinical endpoint bioequivalence studies for OINDPs.
Aptar Pharma Bolsters Clinical Trial Capabilities with Strategic Materials Manufacturing Acquisition
Announcement describing acquisition of a clinical trial materials manufacturing capability, noting operation of an FDA-inspected cGMP facility with cleanrooms, high-potency API suites, biologics capabilities and advanced fill–finish technologies. The article is hosted on the company site and referenced in relation to clinical supply integration.
Press release describing an exclusive collaboration to combine imaging-derived CFD and integrated in‑vitro/in‑silico modelling to support alternative bioequivalence submissions for inhaled products.
Article outlining the use of Model Master Files to reuse validated simulation models and streamline regulatory review for OINDPs.
Announcement of expansion into a larger facility with R&D and cGMP analytical laboratories, and increased particle engineering and spray drying capacity.
Article discussing FDA priorities and the increasing role of modelling and simulation (CFD, PBPK) as alternatives or complements to clinical endpoint bioequivalence studies for OINDPs.
Aptar Pharma Bolsters Clinical Trial Capabilities with Strategic Materials Manufacturing Acquisition
Announcement describing acquisition of a clinical trial materials manufacturing capability, noting operation of an FDA-inspected cGMP facility with cleanrooms, high-potency API suites, biologics capabilities and advanced fill–finish technologies. The article is hosted on the company site and referenced in relation to clinical supply integration.