Inke Inhalation

Delivering high-quality APIs for asthma and COPD therapies, manufactured under EU-GMP standards with advanced micronization technologies.

For more than two decades, Inke has been dedicated to advancing respiratory care through the development and manufacturing of APIs for inhalation therapies. Our strategic vision focuses on delivering high-quality, micronized APIs that meet the stringent requirements of global health authorities.
We combine deep expertise in particle engineering, process optimization, and scale-up with robust regulatory support, ensuring that our partners can bring safe and effective treatments to market faster. Our portfolio addresses the growing demand for therapies targeting asthma and chronic obstructive pulmonary disease (COPD).

Addressing the Global Burden of Asthma and COPD

Respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) represent a major global health burden, affecting hundreds of millions of people worldwide. COPD alone is among the leading causes of morbidity and mortality, with prevalence expected to rise due to aging populations, urbanization, and environmental factors.

Effective inhalation therapies are essential to improve patient outcomes, reduce hospitalizations, and enhance quality of life. APIs for inhalation play a critical role in these treatments, requiring precise particle size control, micronization expertise, and stringent manufacturing standards to ensure efficacy and safety.

Interested in our inhalation APIs?

High-Containment Manufacturing Excellence

Advanced Containment for Inhalation APIs

Our inhalation APIs are manufactured in facilities designed for OEL 1 μg/m³ containment, ensuring maximum operator safety and product integrity. Using glove-box and isolator technology, we handle micronized APIs under controlled conditions, minimizing exposure and guaranteeing compliance with global safety regulations.

This advanced containment approach supports full EU-GMP production, from milligrams to commercial kilos, complemented by rigorous quality systems and periodic inspections from major health authorities worldwide. These capabilities make Inke a trusted partner for complex inhalation APIs.

Inhalation Portfolio - APIs

Our commercial portfolio includes APIs for the treatment of asthma, COPD, and other respiratory conditions, manufactured under EU-GMP standards with full regulatory support. These APIs are available in micronized form for inhalation delivery systems:

PRODUCT INDICATION API MICRONIZED CEP/DMF
Aclidinium bromide COPD ✓ EU-US DMF
Arformoterol tartrateP polymorph A and D COPD ✓ US-CN-KR DMF
Formoterol fumarate Asthma and COPD ✓ CEP/US-CN-JP-KR DMF
Glycopyrronium bromideP COPD ✓ CEP/US-CN-KR DMF
Indacaterol maleateP Asthma and COPD ✓ EU-US-CN-KR DMF
Montelukast sodium Asthma, allergic & seasonal rhinitis   EU-JP DMF
Olodaterol HClP COPD EU-US-CN DMF
Revefenacin COPD EU-US-CN DMF
Salmeterol xinafoateP Asthma and COPD ✓ CEP/US-CN-KR DMF
Tiotropium bromide monohydrate COPD ✓ CEP/US-CN DMF
Umeclidinium bromide COPD ✓ EU-US-CN DMF
Vilanterol trifenatateP Asthma and COPD ✓ EU-US DMF

Pipeline

In addition to our established portfolio, we are actively developing next-generation inhalation APIs for respiratory diseases. These molecules are currently available as laboratory samples for research purposes, reflecting our commitment to innovation and future therapeutic solutions:

THERAPEUTIC AREA PRODUCT INDICATION SAMPLES TECHNICAL PACKAGE VALIDATION BATCH DMF
Antiasthmatics, COPD and respiratory diseases Ensifentrine P COPD ✓ Q1 2026 ✓ Q2 2026
Indacaterol acetate Asthma ✓ ✓ ✓ Q1 2026
Roflumilast COPD ✓ Pending Q3 2026 Pending

CEP = Products with Certificate of Suitability
P = Patent applications/granted patents owned by Inke

Listed products protected by valid patents are developed solely for purposes related to the development, preparation and submission of information to obtain a Marketing Authorization. In particular these products are under development for uses related to the activities stated in Art. 10.6 of Directive 2001/83/EC amended by the Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, i.e. activities carried out to obtain a Marketing Authorization. None of the products are offered for sale or supplied to countries in which they could be in conflict with valid patents.

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From Development to Commercial Scale

Integrated R&D and Analytical Expertise

We integrate process chemistry, particle engineering, and analytical science to accelerate inhalation API development:

  • Micronization under containment with SS‑316L jet mills and isolator-based dispensing for precise PSD and MMAD.
  • Crystalline form control and solid-state characterization (XRD, DSC, TGA, SEM) for polymorph stability.
  • Moisture & stability profiling using DVS and climatic chambers to ensure robust performance.
  • Analytical release with advanced tools (HPLC, UPLC/MS, GC/HS, particle size analyzers) aligned to USP/EP.

Seamless tech transfer from lab to plant is supported by dedicated preparative/weighing booths (OEL 1–10 mg/m³), validated SOPs, and data‑integrity compliant systems (LIMS, SAP, LabX, OpenLab).

Micronization & Particle Engineering

Precision PSD for Inhalation

Performance of inhalation products hinges on precise aerodynamic behavior. Our micronization platform delivers:

  • Narrow, reproducible PSD tailored to DPI carrier blends or MDI suspensions.
  • Control of electrostatic charge, flowability, and surface area to optimize dispersion and emitted dose.
  • In‑process monitoring and post‑micronization stabilization treatments in dedicated cabins to preserve form and PSD.
  • Homogenization & sieving within isolators to ensure batch uniformity and minimize agglomeration.

Outcomes: improved fine particle fraction (FPF), consistent delivered dose, and robust stability profiles across packaging and climatic conditions.

Why Leading Companies Choose Inke for Inhalation APIs

OEL 1 µg/m³ high‑containment design

with glove‑box/isolator operations dedicated to inhalation handling.

Micronization expertise

(jet milling, PSD control, aerodynamic performance) tailored to DPI/MDI requirements.

Solid‑state & moisture control

(XRD/DRX, DSC/TGA, SEM, DVS) to safeguard polymorph purity and stability.

End‑to‑end scalability

from milligrams to commercial kilos with validated tech transfer and data‑integrity systems.

Quality & compliance under EU‑GMP

with successful global inspections and comprehensive DMF/CEP coverage in US/EU/CN/JP/KR.

Driving Innovation in Respiratory APIs

Looking for a trusted supplier of inhalation APIs?

If you’re looking for a reliable partner for inhalation APIs, Inke combines EU-GMP manufacturing, high-containment micronization, and full regulatory support with over 20 years of successful FDA inspections.
From development to commercial scale, we deliver precision, compliance, and tailor-made solutions for asthma and COPD therapies.

Start Your Project Today