Respiratory Strategic Vision

Inke is specialised in the development and manufacturing of active ingredients for use in Respiratory Inhalation therapies for the last two decades.

When it comes to inhalation APIs, precision, consistency, and regulatory confidence are not optional—they are essential. Pharmaceutical companies developing inhaled therapies face the constant challenge of ensuring that every particle, every formulation, and every process step meets the highest standards of performance and safety. The complexity of delivering active ingredients directly to the lungs requires deep scientific understanding and specialized manufacturing expertise. At Inke, we empower our partners to overcome these challenges through a fully integrated approach to the development and production of inhalation-grade active pharmaceutical ingredients (APIs). Our focus lies in supporting innovators and generic manufacturers who need reliable, high-quality APIs specifically optimized for respiratory drug delivery.

Our unwavering commitment ensures that they receive the highest quality assistance to achieve their goals. With a strategic vision deeply rooted in respiratory care, we specialize in the development and manufacturing of high-added-value active ingredients tailored specifically for inhalation therapies. For over two decades, Inke has led the charge in technology, driving the evolution of respiratory active pharmaceutical ingredients to meet the ever-evolving needs of patients and healthcare providers worldwide.

Our Capabilities in Inhalation APIs Development

At Inke, we combine over twenty-five years of experience in respiratory therapies to master the craft of inhalation drug development. We know that delivering active ingredients for use in respiratory inhalation means more than just chemistry—it means engineering every detail: particle size, crystal form, morphology, and purity. We leverage critical in-process controls throughout our stages, from raw materials to finished API, to ensure consistency in respiratory APIs that perform reliably in inhaled drug formulation. Our multipurpose plant supports complex chemical reactions, handling of hazardous materials, and strict cleaning process validation, so you can trust that your API meets the highest quality and safety standards.

We also understand that different projects demand different approaches. Whether you require active ingredients for use in respiratory inhalation with tight particle size distribution or need customization of amorphous content, Inke is equipped. We offer the ability to optimise crystal shape and size, perform micronization, spray-drying, and advanced particle engineering to match your inhalation pharmaceutical solutions expectations. To learn more about our facilities and how we bring technical expertise to life, see our manufacturing assets.

Global Reach, Local Expertise

As a trusted partner to major generic and branded companies, Inke has solidified its position as a key supplier in the global pharmaceutical landscape. Headquartered in Barcelona, Spain, our reach extends far beyond borders, with a continuous international expansion spanning over two decades. From Europe to the United States, Japan, Korea, and China, Inke delivers cutting-edge APIs to every corner of the globe, advancing respiratory care and improving patient outcomes on a global scale.

Canada, USA & Mexico

For detailed information on this market, please reach out to Maite Pascual.

Japan

For detailed information on this market, please reach out to Mónica Capón

Africa

Turkey, South Africa, MENA (Egypt, Algeria, Morocco & Tunisia)

For detailed information on this market, please reach out to Maite Pascual.

India, Bangladesh & Pakistan

For detailed information on this market, please reach out to Maite Pascual.

INKE S.A.

Main Offices:

Avinguda Diagonal, 605 6D,
08028 Barcelona, Spain

Manufacturing Site:

Area Industrial del Llobregat,
Argent 1, 08755 Castellbisbal
Barcelona, Spain

Inke US Office

53 State Street, Suite 500Boston, MA, 02109.

LATAM

Argentina & Brazil

For detailed information on this market, please reach out to Maite Pascual.

Europe

For detailed information on this market, please reach out to Anna Homs.

Spain

For detailed information on this market, please reach out to Maite Pascual.

Asia & Oceania

China, Korea, Taiwan and Southest Asia (Vietnam, Philippines, Thailand & Malaysia), Australia & New Zealand

For detailed information on this market, please reach out to Harry Yuan.

Respiratory Focus

Discover Inke's Difference

Explore how Inke’s unparalleled expertise and unwavering commitment to respiratory health are shaping the future of inhalation therapies. Learn more about our innovative solutions and discover why leading pharmaceutical companies trust Inke as their preferred partner in respiratory care.

Innovation & Process Engineering

We believe innovation is what separates good inhalation APIs from great ones. At Inke, we’ve invested heavily in R&D to push the boundaries of inhalation drug development. This continuous innovation also feeds into how we design inhaled drug formulation, helping our clients reach target delivery profiles with reduced variability.

Our process engineering is built around critical in process controls, cleaning validation, and environmental controls (ISO-7 at final stages). We take pride in our ability to work with contained equipment for hazardous chemistry and advanced particle engineering. To see how our innovation arm contributes, visit our innovation page.

Respiratory APIs in the Main Markets Worldwide

USDMFs

Respiratory APIs
  • Aclidinium bromide
  • Arformoterol tartrate (A)
  • Arformoterol tartrate (D)
  • Formoterol fumarate dihydrate
  • Glycopyrronium bromide
  • Indacaterol maleate
  • Olodaterol hydrochloride
  • Revefenacin trihydrate
  • Salmeterol xinafoate
  • Tiotropium bromide monohydrate
  • Umeclidinium bromide
  • Vilanterol trifenatate

CEPs/EU DMFs

Respiratory APIs
  • Aclidinium bromide
  • Formoterol fumarate dihydrate
  • Glycopyrronium bromide
  • Indacaterol maleate
  • Montelukast sodium
  • Olodaterol hydrochloride
  • Revefenacin trihydrate
  • Salmeterol xinafoate
  • Tiotropium bromide monohydrate
  • Vilanterol trifenatate
  • Umeclidinium bromide

Why Partner with Inke for Your Inhalation API Needs

We understand the pain points of companies developing inhaled therapies: unpredictable particle behaviour, batch inconsistency, regulatory delays, and difficulty in scaling. With Inke, you get a partner who addresses all those: we deliver respiratory APIs with tight specifications, reproducible performance, and strong regulatory backing. We take pride in being proactive, not reactive—anticipating challenges in inhaled drug formulation and solving them early.

Moreover, we don’t just make APIs—we aim to be part of your success story. From the early R&D stage through process validation, manufacturing, and market entry, we offer comprehensive support. We stand among the top in Europe not only for the number of patents we hold but for our commitment to scientific excellence, strong active ingredients for use in respiratory inhalation, and customer collaboration. To understand where we come from and our track record, you can explore our history page.

Know more about our Respiratory Solutions

Explore Our Full Range of Respiratory APIs

Dive into our extensive product portfolio and discover the

high-quality respiratory APIs designed to meet your needs.

Access to detailed information and download product PDFs

by filling the form at the end of the page.

Frequently Asked Questions About Inhalation APIs

What are Inhalation APIs?

Inhalation APIs are active pharmaceutical ingredients specifically designed for drug delivery to the lungs. They are developed and manufactured to achieve precise particle size, morphology, and purity so that inhaled medications perform consistently and safely in respiratory therapies.

Why are Inhalation APIs important for respiratory treatments?

These APIs are at the core of effective inhalation pharmaceutical solutions. By ensuring the right aerodynamic properties and stability, respiratory APIs help deliver medication deep into the lungs, improving bioavailability and patient outcomes for conditions like asthma, COPD, and other chronic respiratory diseases.

What support does Inke provide beyond manufacturing?

Inke partners with clients throughout every stage of inhalation drug development—from feasibility studies and process optimization to regulatory documentation and post-approval lifecycle management. Our team ensures you have a seamless path from lab to commercial scale.

How does Inke ensure regulatory compliance and quality?

We follow strict quality assurance protocols aligned with GMP and international pharmacopeial standards. Inke also leads the industry with 125+ patent applications, demonstrating ongoing innovation in synthetic processes, polymorphic forms, and salts. More details are available on our Quality Assurance page.

How can I start a collaboration with Inke?

You can reach out through our contact form to discuss your project needs. We’ll review your technical requirements and propose a customized solution for your inhalation APIs or respiratory pharmaceutical project.