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    Company profile for Inke S.A

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    Micronization Enhances Bioavailability in Dry Powder Inhalers

    17 Mar 2026

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    APIs for Asthma and COPD: Challenges in Inhalation Formulations

    05 Mar 2026

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    Regulatory Pathways for Inhalable APIs in the EU and US

    23 Feb 2026

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    Inke S.A: APIs manufacturing plant.

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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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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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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    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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    https://www.pharmacompass.com/speak-pharma/due-to-its-20-year-mastery-in-micronization-inke-has-emerged-a-cornerstone-in-treating-global-respiratory-diseases

    #SpeakPharma With Inke
    28 Oct 2024
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2026

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    Corporate Presentation

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    Ophthalmic API Product List 2026

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    Inke Completes Pharmanoid Acquisition

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    API Product List 2026

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    API Under Development 2026

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    CNS API Product List 2026

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    Inhalation API Product List 2026

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    GMP Certificate 2026

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    DATA COMPILATION #PharmaFlow

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    Prostaglandin market to cross US$ 1.27 bn by 2035; Liquidia’s Yutrepia okayed for pulmonary hypertension

    Prostaglandin market to cross US$ 1.27 bn by 2035; Liquidia’s Yutrepia okayed for pulmonary hypertension

    Prostaglandins are natural fatty acid compounds produced by the human body. They are made from a type of fat known as arachidonic acid and act like messengers, controlling many functions such as inflammation, blood flow, muscle contraction, and fluid drainage in the eye. Prostaglandin APIs are synthetic (lab-made) versions of natural prostaglandins that are used to create medicines. Prostaglandin-based medicines are used in obstetrics and gynecology, gastroenterology, urology, and cosmetics, and their use is also being explored in certain cardiovascular and respiratory conditions. One of the largest and most important uses of prostaglandin APIs is in ophthalmology (eye care), where they are used as first-line therapy for open-angle glaucoma (a chronic, progressive eye disease) and ocular hypertension (a condition where pressure inside the eye is consistently higher than normal). In ophthalmic applications, these drugs usually serve as prodrugs – inactive in the formulation but converted into their active form after entering the eye.According to estimates, the global prostaglandin market is valued at US$ 0.63 billion in 2025 and is poised to grow from US$ 0.68 billion in 2026 to US$ 1.27 billion by 2035, growing at a CAGR of 7.1 percent between 2026 and 2035.Prostaglandin API manufacturing is a highly specialised field, with only a few experienced manufacturers. Companies such as EUROAPI, Cayman Pharma, Chirogate International, Kyowa Pharma Chemical, Everlight Chemical, and Yonsung Fine Chemicals are key players with strong capabilities in complex chemistry.FDA allows Glaukos’ iDose TR to be re-administered for treating eye diseases; approves Liquidia’s Yutrepia The prostaglandin market continues to see steady regulatory activity and innovations. In ophthalmology, Glaukos Corporation’s iDose TR received a labelling supplement from the US Food and Drug Administration (FDA) that allows for re-administration of the medication indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The intracameral implant was originally approved in December 2023 for single use. This update was supported by long-term safety data demonstrating good tolerability in patients with OAG and OHT. Similarly, Santen Pharmaceutical secured manufacturing and marketing approval in Japan for Setaneo (sepetaprost) ophthalmic solution 0.002% in August 2025 for the treatment of glaucoma and OHT. In April 2025, Santen also received approval in China for Tapcom (tafluprost + timolol maleate), a preservative-free fixed-dose combination therapy that lowers intraocular pressure (IOP) in patients with OAG and OHT.Beyond ophthalmology, prostaglandin APIs are also driving advancements in respiratory care. Liquidia Corporation received FDA approval in May 2025 for Yutrepia (treprostinil) inhalation powder for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). While PAH is a serious and progressive disease where blood pressure in the lung arteries rises, causing them to narrow and harden, PH-ILD is a serious complication in which high blood pressure develops in the lung arteries due to lung scarring. Yutrepia is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary technology.  Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Nicox’s drug scores phase 3 win in glaucoma, OHT; United seeks expanded approval for Tyvaso to treat pulmonary fibrosisInnovation in prostaglandins is increasingly focused on enhanced efficacy and sustained drug delivery. French ophthalmology company Nicox has reported positive phase 3 results for its ophthalmic solution NCX 470, demonstrating consistent lowering of intraocular pressure in OAG and OHT. Nicox is likely to submit a new drug application for NCX 470 sometime soon, with a potential approval and launch expected in 2027.Meanwhile, US-based SpyGlass Pharma is advancing sustained-release innovation through intraocular lens (IOL)-based and ring-based drug delivery systems. Its Bimatoprost Drug Pad–Intraocular Lens (BIM-IOL) system (currently in phase 3 trials) integrates drug delivery with cataract surgery to enable sustained therapy for up to three years. The company is also developing a preclinical Bimatoprost Drug Ring System (BIM-DRS) designed for similarly extended drug release. In respiratory indications, Insmedis progressing treprostinil palmitil inhalation powder through phase 3 trials for PH-ILD, as well as for idiopathic pulmonary fibrosis and PAH.Additionally, United Therapeutics is expanding the clinical scope of Tyvaso DPI (treprostinil). Following its global approval in 2022 for PAH, the therapy is now under regulatory review in the US and Canada for progressive pulmonary fibrosis and idiopathic pulmonary fibrosis.  Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Glaukos sets up new R&D facility in Alabama, Inke acquires Pharmanoid to strengthen presence in prostaglandins Several players are expanding capacities due to rising demand across ophthalmology. Glaukos Corporation is setting up a new research, development, and manufacturing facility in Huntsville, Alabama. The planned 200,000 square-foot site, to be built on a 25-acre campus in Cummings Research Park, envisages an investment of over US$ 80 million. Expected to be completed by 2030, the facility is designed to augment the company’s existing infrastructure and support long-term growth, particularly in ophthalmic therapies including sustained-release drug delivery systems.EUROAPIis undertaking a significant capacity expansion at its Budapest site. The company has committed €50 million (US$ 54.8 million) to install a new state-of-the-art production plant focused on prostaglandins. The project aims to debottleneck existing operations and introduce new multi-purpose manufacturing equipment, ultimately more than doubling the site’s prostaglandin production capacity by 2027. The expansion will also strengthen EUROAPI’s highly potent API (HPAPI) capabilities.Alongside capacity additions by established players, the market is also witnessing consolidation and capability expansion through acquisitions. For instance, Essential Pharma acquired Ventavis (iloprost trometamol) from Bayer AG, including rights to the accompanying Breelib nebuliser delivery technology. Ventavis, a prostacyclin analogue, is a well-established treatment for adult patients with primary pulmonary hypertension.Inke strengthened its presence in ophthalmology-focused high-potency APIs (HPAPIs), including prostaglandins, through the acquisition of Pharmanoid in December 2025. Backed by regulatory approvals across 25+ countries, Pharmanoid enhances Inke’s capabilities in complex API production and supports its ambition to build a leading European platform for advanced API development and manufacturing. The Barcelona facility is capable of producing and handling APIs across all potency levels while adhering to SafeBridge Scale OEB4 (Occupational Exposure Band 4) containment protocols, a classification for high-potency substances requiring strict controls to limit occupational exposure.With more than two decades of experience, Inke is recognized for innovating and manufacturing high-quality APIs, delivering expertise, safety, and excellence across inhalation, CNS, and ophthalmic therapies, while supporting pharmaceutical companies worldwide. The ophthalmic API commercial portfolio includes bimatoprost, latanoprost, tafluprost, and travoprost, while the next-generation prostaglandin analog pipeline includes bimatoprost grenod and latanoprostene bunod.  Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Our viewInnovation is guiding the prostaglandins market towards long-acting, sustained-release formulations and novel delivery systems. These innovations are driving steady growth in prostaglandins, while capacity expansions are strengthening capabilities in complex and highly potent APIs. Overall, this remains a niche but important market to watch. 
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    https://www.pharmacompass.com/radio-compass-blog/prostaglandin-market-to-cross-us-1-27-bn-by-2035-liquidia-s-yutrepia-okayed-for-pulmonary-hypertension

    #PharmaFlow by PHARMACOMPASS
    14 May 2026
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    NEWS #PharmaBuzz

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    Micronization Enhances Bioavailability in Dry Powder Inhalers
    Micronization Enhances Bioavailability in Dry Powder Inhalers

    17 Mar 2026

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    https://www.inke.es/news/how-micronization-enhances-bioavailability-in-dpis/

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    17 Mar 2026
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    APIs for Asthma and COPD: Challenges in Inhalation Formulations
    APIs for Asthma and COPD: Challenges in Inhalation Formulations

    05 Mar 2026

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    https://www.inke.es/news/apis-for-asthma-and-copd-challenges/

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    05 Mar 2026
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    Regulatory Pathways for Inhalable APIs in the EU and US
    Regulatory Pathways for Inhalable APIs in the EU and US

    23 Feb 2026

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    https://www.inke.es/news/regulatory-pathways-for-inhalable-apis-eu-us/

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    23 Feb 2026
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    Upcoming Trends in Inhalation Drug Delivery Technologies
    Upcoming Trends in Inhalation Drug Delivery Technologies

    12 Feb 2026

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    https://www.inke.es/news/upcoming-trends-in-inhalation-drug-delivery/

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    12 Feb 2026
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    Advanced Particle Engineering for Reliable& High-Performance APIs
    Advanced Particle Engineering for Reliable& High-Performance APIs

    29 Jan 2026

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    https://www.inke.es/news/science-behind-particle-engineering-for-inhalation-therapies/

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    29 Jan 2026
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    How to Select a Strategic API Partner High-Quality Manufacturer
    How to Select a Strategic API Partner High-Quality Manufacturer

    14 Jan 2026

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    https://www.inke.es/news/choosing-the-right-api-supplier-5-critical-criteria/

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    14 Jan 2026
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    ALL APIs

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    01

    Formoterol Fumarate

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
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    • fda
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    USDMF arrow-down Click Us! arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-06-16

    Pay. Date : 2017-05-10

    DMF Number : 16628

    Submission : 2003-06-03

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2006-024 - Rev 03

    Issue Date : 2025-03-27

    Type : Chemical

    Substance Number : 1724

    Status : Valid

     JDMF arrow-down
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    Registration Number : 224MF10042

    Registrant's Address : Area Industrial del Llobregat, C/Argent 1,08755 Castellbisbal Barcelona SPAIN

    Initial Date of Registration : 2012-02-28

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
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    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2013-08-19

    Registration Number : 20130819-187-I-288-06

    Manufacturer Name : INKE SA

    Manufacturer Address : Argent,1, Area Industrial del Llobregat, Castellbisbal 08755 (Barcelona), Spain.

     VMF CN arrow-down
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    Available Reg. Filing : CN
    AUDIT arrow-down
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    02

    Granisetron Hydrochloride

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
    Attending
    • fda
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-12-10

    Pay. Date : 2021-12-07

    DMF Number : 17346

    Submission : 2004-04-05

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2008-030 - Rev 01

    Issue Date : 2016-03-17

    Type : Chemical

    Substance Number : 1695

    Status : Valid

     JDMF arrow-down
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    Registration Number : 218MF10350

    Registrant's Address : Area Industrial del Llobregat, C/Argent 1,08755 Castellbisbal Barcelona SPAIN

    Initial Date of Registration : 2006-03-17

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
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    Registrant Name : Hana Pharmaceutical Co., Ltd.

    Registration Date : 2014-04-30

    Registration Number : 20130314-177-I-205-02(1)

    Manufacturer Name : INKE, SA

    Manufacturer Address : Area Industrial del Llobregat, C/ Argent, 1 08755 CASTELLBISBAL, Barcelona, ​​SPAIN

     VMF Others AUDIT arrow-down
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    03

    Aprepitant

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-05-31

    Pay. Date : 2022-05-16

    DMF Number : 35497

    Submission : 2022-04-26

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2022-247 - Rev 00

    Issue Date : 2024-10-29

    Type : Chemical

    Substance Number : 2757

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    Inke Company Banner

    04

    Glycopyrronium Bromide

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-02-16

    Pay. Date : 2017-07-06

    DMF Number : 31836

    Submission : 2017-07-22

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2017-182 - Rev 00

    Issue Date : 2023-08-17

    Type : Chemical

    Substance Number : 1783

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    NDC Package Code : 64567-0018

    Start Marketing Date : 2017-07-28

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2020-11-03

    Registration Number : 20201103-211-J-782

    Manufacturer Name : INKE SA

    Manufacturer Address : C/Argent 1, Area Industrial del Llobregat 08755 Castellbisbal Barcelona, ​​Spain

     VMF CN arrow-down
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    Available Reg. Filing : CN
    AUDIT arrow-down
    Inke Company Banner

    05

    Ondansetron Hydrochloride

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16317

    Submission : 2002-12-13

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2005-056 - Rev 00

    Issue Date : 2012-05-24

    Type : Chemical

    Substance Number : 2016

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    Inke Company Banner

    06

    Risperidone

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-06-09

    Pay. Date : 2021-06-04

    DMF Number : 15682

    Submission : 2001-10-23

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2006-054 - Rev 00

    Issue Date : 2012-07-16

    Type : Chemical

    Substance Number : 1559

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
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    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-10-C-84-08

    Manufacturer Name : INKE SA

    Manufacturer Address : Area Industrial del Llobregat, C/Argent 1, 08755 Castellbisbal Barcelona

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    Salmeterol Xinafoate

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-08-12

    Pay. Date : 2015-05-20

    DMF Number : 23914

    Submission : 2010-06-23

    Status : Active

    Type : II

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

    Issue Date : 2014-06-16

    Type : Chemical

    Substance Number : 1765

    Status : Valid

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    Tiotropium Bromide

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-04-30

    Pay. Date : 2020-01-13

    DMF Number : 34410

    Submission : 2020-03-17

    Status : Active

    Type : II

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    Certificate Number : CEP 2019-337 - Rev 02

    Issue Date : 2025-10-24

    Type : Chemical

    Substance Number : 2420

    Status : Valid

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    Granisetron

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21790

    Submission : 2008-06-24

    Status : Active

    Type : II

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    Ondansetron

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16172

    Submission : 2002-09-30

    Status : Active

    Type : II

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    KDMF

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    Enalapril maleate

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    Inke S.A

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-12-B-49-06

    Manufacturer Name : Inke, SA(Grupo vita)

    Manufacturer Address : Area Industrial del Llobregat, C/Argent 1, 08755 Castellbisbal Barcelona

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    Formoterol fumarate hydrate

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    Inke S.A

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2013-08-19

    Registration Number : 20130819-187-I-288-06

    Manufacturer Name : INKE SA

    Manufacturer Address : Argent,1, Area Industrial del Llobregat, Castellbisbal 08755 (Barcelona), Spain.

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    Glycopyronium bromide

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    Inke S.A

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2020-11-03

    Registration Number : 20201103-211-J-782

    Manufacturer Name : INKE SA

    Manufacturer Address : C/Argent 1, Area Industrial del Llobregat 08755 Castellbisbal Barcelona, ​​Spain

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    Granisetron hydrochloride

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    Inke S.A

    Registrant Name : Hana Pharmaceutical Co., Ltd.

    Registration Date : 2014-04-30

    Registration Number : 20130314-177-I-205-02(1)

    Manufacturer Name : INKE, SA

    Manufacturer Address : Area Industrial del Llobregat, C/ Argent, 1 08755 CASTELLBISBAL, Barcelona, ​​SPA...

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    Granisetron hydrochloride

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    Inke S.A

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2013-03-14

    Registration Number : 20130314-177-I-205-02

    Manufacturer Name : INKE, SA

    Manufacturer Address : Area Industrial del Llobregat, C/ Argent, 1 08755 CASTELLBISBAL, Barcelona, ​​SPA...

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    Indacaterol maleate

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    Inke S.A

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2020-10-27

    Registration Number : Su207-45-ND

    Manufacturer Name : INKE SA

    Manufacturer Address : 08755 Area Industrial del Llobregat, C/Argent 1, Castellbisbal Barcelona, ​​Spain

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    Olanzapine

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    Inke S.A

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2020-11-13

    Registration Number : 20201113-209-J-568

    Manufacturer Name : INKE SA

    Manufacturer Address : C/Argent, 1. Area Industrial del Llobregat, 08755 Castellbisbal (Barcelona), Spain

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    Quetiapine fumarate

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    Inke S.A

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2013-03-15

    Registration Number : 20130315-172-I-248-10

    Manufacturer Name : INKE, SA

    Manufacturer Address : Area industrial del Llobregat. C/Argent 1, 08755, Castellbisbal. Barcelona. Spain

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    Risperidon

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    Inke S.A

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-10-C-84-08

    Manufacturer Name : INKE SA

    Manufacturer Address : Area Industrial del Llobregat, C/Argent 1, 08755 Castellbisbal Barcelona

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    NDC API

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    01

    ACLIDINIUM BROMIDE

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    Inke S.A

    NDC Package Code : 64567-0028

    Start Marketing Date : 2022-01-13

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    ARFORMOTEROL TARTRATE

    Spain
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    Inke S.A

    NDC Package Code : 64567-0020

    Start Marketing Date : 2018-07-19

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    GLYCOPYRROLATE

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    Inke S.A

    NDC Package Code : 64567-0018

    Start Marketing Date : 2017-07-28

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    OLANZAPINE

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    Inke S.A

    NDC Package Code : 64567-0017

    Start Marketing Date : 2013-01-24

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    REVEFENACIN

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    Inke S.A

    NDC Package Code : 64567-0029

    Start Marketing Date : 2022-01-13

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    UMECLIDINIUM BROMIDE

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    Inke S.A

    NDC Package Code : 64567-0030

    Start Marketing Date : 2022-01-13

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    LISTED APIs

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    Aclidinium Bromide

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    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 b...
    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Aclidinium Bromide

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    Inke S.A

    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : 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...

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    Aprepitant

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    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 b...
    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Aprepitant

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    Inke S.A

    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : 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...

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    Arformoterol Tartrate

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    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 b...
    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Arformoterol Tartrate

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    Inke S.A

    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : 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...

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    Asenapine Maleate

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    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 b...
    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Asenapine Maleate

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    Inke S.A

    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : 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...

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    Bimatoprost

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    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 b...
    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Bimatoprost

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    Inke S.A

    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : 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...

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    Bimatoprost Grenod

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    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 b...
    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Bimatoprost Grenod

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    Inke S.A

    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    Carvedilol

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    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 b...
    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Carvedilol

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    Inke S.A

    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : 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...

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    Clevidipine Butyrate

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    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 b...
    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Clevidipine Butyrate

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    Inke S.A

    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : 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...

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    Daprodustat

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    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 b...
    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Daprodustat

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    Inke S.A

    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : 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...

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    Daridorexant

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    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 b...
    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Daridorexant

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    Virtual BoothInke S.A: APIs manufacturing plant.

    Inke S.A

    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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : 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...

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    Inke S.A is a supplier offers 51 products (APIs, Excipients or Intermediates).

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