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    Company profile for Inke S.A

    Inke SA-PSE
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    Formoterol Fumarate: Inke’s Flagship API for Respiratory Health

    13 May 2025

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    Inke’s Emissions Reduction Targets Approved by the SBTi

    03 Apr 2025

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    Inke highlights the importance of EU capital markets EIB interview

    04 Feb 2025

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    About

    Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation.

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    Inke S.ASpain_new Flag
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    Spain
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    Area Industrial Llobregat, Argent,1 08755 Castellbisbal Barcelona
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    +34 936828180
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    contact-inke@inke.es
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    https://www.inke.es/
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    CPhI WW Frankfurt

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    INTERVIEW #SpeakPharma

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    “Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

    mic“Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

    This week, SpeakPharma interviews Miquel Bachs, CEO of Inke, a company with over two decades of expertise in micronization and particle engineering, and a leader in providing high-quality, effective solutions in the global fight against chronic respiratory diseases such as COPD and asthma. In this insightful conversation, Bachs shares Inke’s strategic vision, technological innovations, and commitment to sustainability, offering a comprehensive look at how the company is shaping the future of respiratory health. HIGHLIGHTS// Inke’s strategic vision/ technological innovations/ commitment to sustainability Studies suggest that 13 percent of people over 40 years of age, the world over, have chronic obstructive pulmonary disease (COPD). Given the increasing prevalence of respiratory diseases, how does Inke position itself as a leader in the development and manufacturing of respiratory APIs? Inke has established itself as a global leader in generic respiratory API development through our unique blend  of technological innovation, expertise in micronization, and a comprehensive portfolio of inhalation therapies. With over 20 years of experience in micronization and particle engineering, our ability to customize APIs to meet specific client requirements has resulted in highly effective, high-quality products tailored for respiratory therapies. The increasing prevalence of chronic respiratory diseases, such as COPD and asthma, has only underscored Inke’s pivotal role in supporting the pharmaceutical industry’s need for advanced treatments. We specialize in bronchodilators and other critical respiratory APIs that improve patient outcomes and meet the stringent regulatory requirements of global health authorities. Our end-to-end approach, from early-stage API development to commercial-scale production, ensures that we maintain the highest standards of quality, safety, and efficacy. As the market for respiratory APIs continues to evolve, Inke remains committed to expanding its portfolio to address unmet therapeutic needs. Beyond respiratory APIs, we are also prioritizing growth in CNS treatments and building on our expertise in complex molecule synthesis. This strategic focus allows us to provide an integrated solution that not only meets current market demands but also anticipates future pharmaceutical trends. HIGHLIGHTS// comprehensive portfolio of inhalation therapies/ over 20 years of experience in micronization and particle engineering/ specialize in bronchodilators and other critical respiratory APIs/ prioritizing growth in CNS treatments In the field of micronization, what differentiates Inke’s approach from that of other manufacturers of respiratory APIs? What sets Inke apart in micronization is our advanced particle size reduction technology and our dedication to precision. Our facility is equipped with various milling techniques such as Cone, Jet, and Pin mills, allowing us to reduce particle size while stabilizing the amorphous content to ensure consistent quality. Our in-depth understanding of respiratory APIs, combined with our ability to tailor solutions for each customer, results in APIs with improved solubility, stability, and bioavailability, which are critical for the efficacy of inhalation products. This, along with our exceptional quality standards and a flawless audit track record, has positioned us as a key partner for major players in the inhalation market. HIGHLIGHTS// advanced particle size reduction technology/ technological innovations/ tailor solutions/ improved solubility, stability, and bioavailability Developing complex APIs can be challenging. How does Inke ensure a smooth and successful partnership throughout the development and manufacturing process, including customization, ensuring regulatory compliance and timely delivery? At Inke, we are dedicated to fostering strong partnerships with our clients through a collaborative approach that prioritizes open communication and mutual understanding. Our commitment to quality and personalized service sets us apart in the pharmaceutical landscape. Our team takes the time to engage in comprehensive discussions to customize our solutions, ensuring alignment with client specifications across all batches and grades. This commitment to flexibility allows us to respond effectively to evolving requirements, solidifying Inke’s reputation as a reliable partner. We understand that navigating regulatory landscapes can be challenging. That's why our team is equipped to manage all aspects of the regulatory process with meticulous attention to detail. From the submission of Drug Master Files (DMFs) and Certificates of Suitability to crafting precise responses to potential Deficiency Letters, we ensure compliance at every step. Moreover, we offer extensive support in patent and intellectual property matters, providing technical assistance and guidance tailored to the specific requirements of each region. Our unwavering dedication to quality, coupled with our agile response capabilities, enables us to deliver exceptional results while maintaining transparency and trust. At Inke, we are committed to building lasting relationships that drive success for both our clients and our organization. HIGHLIGHTS// ensuring alignment with client specifications/ manage all aspects of the regulatory process/ support in patent and intellectual property matters Given Inke’s global presence, what are the key markets for growth and how does Inke plan to expand its market reach and strengthen its position in these regions? Inke is strategically focused on expanding its footprint in the European and US markets, where we continue to prioritize our efforts. The US market remains pivotal for us, especially considering our successful FDA inspections and ongoing regulatory compliance efforts that solidify our reputation. Japan is another significant market where we have established a robust presence, reflecting our commitment to high-quality manufacturing and innovation. Looking ahead, China represents a key growth opportunity for Inke. With 12 active DMFs registered, we are well-positioned to tap into this burgeoning market. Our strategy involves leveraging our existing capabilities to navigate regulatory landscapes and fostering strong partnerships within the region, thereby enhancing our market reach and influence in the pharmaceutical sector. HIGHLIGHTS// expanding footprint in the European and US markets/ China represents a key growth opportunity for Inke With Inke expanding into contract manufacturing organization (CMO) services, how does this new offering align with Inke’s broader strategic goals, and what advantages does it provide to pharmaceutical partners? At Inke, the introduction of CMO services is a natural extension of our core expertise in the development and manufacturing of high-quality generic APIs. Our expansion into CMO is part of a strategic move to diversify our service portfolio, allowing us to offer end-to-end solutions for our clients. The CMO service integrates seamlessly with our expertise in API manufacturing, particularly in micronization, which has been a key differentiator for Inke for over two decades. With our advanced particle engineering capabilities, we can offer tailored solutions that meet specific technical and regulatory requirements. Whether it is small-batch production or scaling up to commercial quantities, we offer the flexibility to accommodate a wide range of customer needs. This adaptability, paired with our deep expertise in micronization, allows us to support evolving project needs, maintaining the highest standards of consistency, quality, and performance that define Inke’s footprint. HIGHLIGHTS// CMO is part of a strategic move to diversify our service portfolio/ deep expertise in micronization What is Inke’s commitment to sustainability and corporate social responsibility and how is it integrating sustainable practices into its operations and product development? At Inke, we recognize that integrating environmental, social, and governance (ESG) principles into our operations is not just a responsibility but a pathway to long-term success. Our ESG vision is centered around aligning business growth with sustainable practices that positively impact our communities and the environment. We are dedicated to environmental responsibility, actively implementing initiatives such as efficient wastewater treatment and water reuse systems to minimize our ecological footprint. Our recent investments in energy efficiency include the installation of a 135 kWp solar panel system, which underscores our commitment to reducing emissions and resource consumption across our manufacturing and research facilities. Inke is also committed to fostering a diverse and inclusive workforce. With a notable increase in our team members, particularly in operations and quality assurance, we prioritize career development and the well-being of our employees. By adhering to high regulatory standards, we ensure our products meet stringent global requirements, enhancing our transparency and compliance. Through these initiatives, Inke aims to cultivate sustainable practices that not only support our business objectives but also contribute positively to the pharmaceutical industry and society at large. HIGHLIGHTS// integrating ESG principles/ efficient wastewater treatment and water reuse systems/ installation of a 135 kWp solar panel system/ diverse and inclusive workforce

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    28 Oct 2024
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2025

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    Corporate Presentation

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    API Product List 2025

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    API Under Development 2025

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    CNS API Product List 2025

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    Inhalation API Product List 2025

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    GMP Certificate 2023

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    NEWS #PharmaBuzz

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    Formoterol Fumarate: Inke’s Flagship API for Respiratory Health
    Formoterol Fumarate: Inke’s Flagship API for Respiratory Health

    13 May 2025

    // PRESS RELEASE

    https://www.inke.es/news/formoterol-fumarate-inkes-flagship-api-for-respiratory-health/

    PRESS RELEASE
    13 May 2025
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    Inke’s Emissions Reduction Targets Approved by the SBTi
    Inke’s Emissions Reduction Targets Approved by the SBTi

    03 Apr 2025

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    https://www.inke.es/news/inkes-near-term-emissions-reduction-targets-approved-by-the-sbti/#

    PRESS RELEASE
    03 Apr 2025
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    Inke highlights the importance of EU capital markets EIB interview
    Inke highlights the importance of EU capital markets EIB interview

    04 Feb 2025

    // PRESS RELEASE

    https://www.inke.es/news/inke-highlights-the-importance-of-european-capital-markets-in-eib-interview/

    PRESS RELEASE
    04 Feb 2025
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    Inke Names Vanessa Martinez As HSE Head To Drive Sustainability Goals
    Inke Names Vanessa Martinez As HSE Head To Drive Sustainability Goals

    14 Jan 2025

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    https://www.inke.es/news/inke-promotes-vanessa-martinez-to-hse-director-strengthening-our-commitment-to-sustainability/

    PRESS RELEASE
    14 Jan 2025
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    Inke Expands Its Reach in China with New DMF Approvals
    Inke Expands Its Reach in China with New DMF Approvals

    07 Jan 2025

    // PRESS RELEASE

    https://www.inke.es/news/inke-expands-its-reach-in-china-with-new-dmf-approvals/

    PRESS RELEASE
    07 Jan 2025
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    Inke Achieves Aprepitant CEP and Salmeterol DMF A Step Forward
    Inke Achieves Aprepitant CEP and Salmeterol DMF A Step Forward

    04 Dec 2024

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    https://www.inke.es/news/inke-achieves-aprepitant-cep-and-salmeterol-dmf-a-step-forward/

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    04 Dec 2024
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    CEP/COS

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    Aprepitant, Micronised and non micronise...

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    Inke S.A

    Certificate Numbers : CEP 2022-247 - Rev 00

    Status : Valid

    Issue Date : 2024-10-29

    Type : Chemical

    Substance Number : 2757

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    Enalapril maleate

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    Certificate Numbers : R1-CEP 2000-070 - Rev 04

    Status : Valid

    Issue Date : 2019-02-21

    Type : Chemical

    Substance Number : 1420

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    Formoterol fumarate dihydrate, Micronise...

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    Certificate Numbers : CEP 2006-024 - Rev 03

    Status : Valid

    Issue Date : 2025-03-27

    Type : Chemical

    Substance Number : 1724

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    Glycopyrronium bromide, Micronised, non-...

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    Certificate Numbers : R1-CEP 2017-182 - Rev 00

    Status : Valid

    Issue Date : 2023-08-17

    Type : Chemical

    Substance Number : 1783

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    Granisetron hydrochloride

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    Certificate Numbers : R1-CEP 2008-030 - Rev 01

    Status : Valid

    Issue Date : 2016-03-17

    Type : Chemical

    Substance Number : 1695

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    Nitrendipine

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    Certificate Numbers : R1-CEP 2000-132 - Rev 01

    Status : Valid

    Issue Date : 2012-06-20

    Type : Chemical

    Substance Number : 1246

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    Ondansetron hydrochloride dihydrate

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    Certificate Numbers : R1-CEP 2005-056 - Rev 00

    Status : Valid

    Issue Date : 2012-05-24

    Type : Chemical

    Substance Number : 2016

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    Risperidone

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    Certificate Numbers : R1-CEP 2006-054 - Rev 00

    Status : Valid

    Issue Date : 2012-07-16

    Type : Chemical

    Substance Number : 1559

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    Salmeterol xinafoate

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    Certificate Numbers : R1-CEP 2007-127 - Rev 00

    Status : Valid

    Issue Date : 2014-06-16

    Type : Chemical

    Substance Number : 1765

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    Tiotropium bromide monohydrate, Micronis...

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    Certificate Numbers : R0-CEP 2019-337 - Rev 01

    Status : Valid

    Issue Date : 2023-05-16

    Type : Chemical

    Substance Number : 2420

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    KEY PRODUCTS

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    Services

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    API Manufacturing

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    API & Drug Product Development

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    Inspections and registrations

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    EDQM

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    GMP Certified

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    Type : GMP Certificates

    Number : NCF-II/2307...

    EudraGMDP Key : 162326

    Country : Spain

    Issue Date : 2023-03-06

    Post Code :

    NCA Ref : 10128-001

    City : Castellbisbal

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    GMP Certified

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    Type : GMP Certificates

    Number : NCF-II/2217...

    EudraGMDP Key : 150521

    Country : Spain

    Issue Date : 2022-04-13

    Post Code :

    NCA Ref : 10128-001

    City : Castellbisbal

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    GMP Certified

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    Type : GMP Certificates

    Number : NCF-II/2123...

    EudraGMDP Key : 130804

    Country : Spain

    Issue Date : 2021-06-08

    Post Code :

    NCA Ref : 10128-001

    City : Castellbisbal

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    GMP Certified

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    Type : GMP Certificates

    Number : NCF-II/2019...

    EudraGMDP Key : 98642

    Country : Spain

    Issue Date : 2020-07-30

    Post Code :

    NCA Ref : 10128-001

    City : Castellbisbal

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    GMP Certified

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    Type : GMP Certificates

    Number : NCF-II/1932...

    EudraGMDP Key : 75855

    Country : Spain

    Issue Date : 2019-10-23

    Post Code :

    NCA Ref : 10128-001

    City : Castellbisbal

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    GMP Certified

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    Type : GMP Certificates

    Number : NCF-II/&191...

    EudraGMDP Key : 54658

    Country : Spain

    Issue Date : 2019-05-02

    Post Code :

    NCA Ref : 10128-001

    City : Castellbisbal

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    GMP Certified

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    Type : GMP Certificates

    Number : NCF-II/1910...

    EudraGMDP Key : 53950

    Country : Spain

    Issue Date : 2019-02-19

    Post Code :

    NCA Ref : 10128-001

    City : Castellbisbal

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    08

    GMP Certified

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    Type : GMP Certificates

    Number : NCF/1740/00...

    EudraGMDP Key : 42404

    Country : Spain

    Issue Date : 2017-06-21

    Post Code :

    NCA Ref : 10128-001

    City : Castellbisbal

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    09

    GMP Certified

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    Type : GMP Certificates

    Number : ES/069/11

    EudraGMDP Key : 12964

    Country : Spain

    Issue Date : 2011-07-07

    Post Code :

    NCA Ref : 259001

    City : Castellbisbal

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