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    Company profile for Inke S.A

    Inke SA-PSE
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    Inke unveils its New Brand Identity reflecting Growth and Innovation

    05 Sep 2024

    // PRESS RELEASE

    Neuraxpharm agrees on divestment of inhalation API specialist Inke to Keensight

    12 Jun 2024

    // PRESS RELEASE

    INKE increases its production capacity with the support of ACCIÓ

    06 Jun 2024

    // PRESS RELEASE

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    speak-pharma/due-to-its-20-year-mastery-in-micronization-inke-has-emerged-a-cornerstone-in-treating-global-respiratory-diseases

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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.

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    Inke S.ASpain_new Flag
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    Spain
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    Address
    Area Industrial Llobregat, Argent,1 08755 Castellbisbal Barcelona
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    Telephone
    +34 936828180
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    jsanchez@inke.es
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    https://www.inke.es/
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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”

    “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 2024

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    Corporate Presentation

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    API Product List 2024

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    Inhalation API Product List 2024

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    GMP Certificate 2023

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    NEWS #PharmaBuzz

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    Inke unveils its New Brand Identity reflecting Growth and Innovation
    Inke unveils its New Brand Identity reflecting Growth and Innovation

    05 Sep 2024

    // PRESS RELEASE

    https://www.inke.es/news/inke-unveils-its-new-brand-identity-reflecting-growth-and-innovation/

    PRESS RELEASE
    05 Sep 2024
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    Neuraxpharm agrees on divestment of inhalation API specialist Inke to Keensight
    Neuraxpharm agrees on divestment of inhalation API specialist Inke to Keensight

    12 Jun 2024

    // PRESS RELEASE

    https://www.inke.es/news/neuraxpharm-agrees-on-the-divestment-of-inhalation-api-specialist-inke-to-keensight-capital-3/

    PRESS RELEASE
    12 Jun 2024
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    INKE increases its production capacity with the support of ACCIÓ
    INKE increases its production capacity with the support of ACCIÓ

    06 Jun 2024

    // PRESS RELEASE

    https://www.inke.es/news/inke-increases-its-production-capacity-with-the-support-of-accio-generalitat-de-catalunya-5/

    PRESS RELEASE
    06 Jun 2024
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    Clifford Chance advises on the financing for Keensight Capital’s acquisition of Inke
    Clifford Chance advises on the financing for Keensight Capital’s acquisition of Inke

    21 Jun 2023

    // IBERIANLAWYER

    https://iberianlawyer.com/clifford-chance-advises-on-the-financing-for-keensight-capitals-acquisition-of-inke/?print-posts=pdf#:~:text=Clifford%20Chance%20has%20advised%20Eurazeo,to%20the%20Neuraxpharm%20pharmaceutical%20group.

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    21 Jun 2023
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    Neuraxpharm announces closing of acquisition of established products from Sanofi
    Neuraxpharm announces closing of acquisition of established products from Sanofi

    01 Feb 2023

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/neuraxpharm-announces-closing-of-acquisition-of-established-products-from-sanofi-301735596.html

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    01 Feb 2023
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    Neuraxpharm completes its presence in Benelux by opening an affiliate
    Neuraxpharm completes its presence in Benelux by opening an affiliate

    24 Jan 2023

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/neuraxpharm-completes-its-presence-in-benelux-by-opening-an-affiliate-in-brussels-to-cover-belgium-and-luxembourg-301728349.html

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    24 Jan 2023
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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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    Rescon USA Summit
    Exhibiting
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    Virtual BoothInke S.A: APIs manufacturing plant.
    USDMF arrow-down Click Us! arrow-down
    ✖

    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 : R1-CEP 2006-024 - Rev 02

    Issue Date : 2020-10-15

    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 arrow-down
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    NDC Package Code : 64567-0006

    Start Marketing Date : 2008-06-17

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samoh 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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    Available Reg. Filing : CN
    AUDIT
    Inke Company Banner

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    02

    Granisetron Hydrochloride

    Spain

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

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    Rescon USA Summit
    Exhibiting
    • 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
    ✖

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

    Issue Date : 2016-03-17

    Type : Chemical

    Substance Number : 1695

    Status : Valid

     JDMF arrow-down
    ✖

    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 arrow-down
    ✖

    NDC Package Code : 64567-0009

    Start Marketing Date : 2009-10-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    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
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    03

    Fluconazole

    Spain

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

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    Rescon USA Summit
    Exhibiting
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14714

    Submission : 1999-12-15

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2007-219 - Rev 02

    Issue Date : 2019-06-14

    Type : Chemical

    Substance Number : 2287

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    NDC Package Code : 64567-0002

    Start Marketing Date : 2011-06-07

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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

    Registration Date : 2005-08-31

    Registration Number : 20050831-74-A-158-11

    Manufacturer Name : INKE SA

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

     VMF NA Not Available For Sales AUDIT
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    04

    Glycopyrronium Bromide

    Spain

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

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    Rescon USA Summit
    Exhibiting
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    USDMF arrow-down
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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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Samoh 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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    Available Reg. Filing : CN
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    05

    Ondansetron Hydrochloride

    Spain

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

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    Rescon USA Summit
    Exhibiting
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    USDMF arrow-down
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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 arrow-down
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    NDC Package Code : 64567-0005

    Start Marketing Date : 2009-08-19

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Inke Company Banner

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    06

    Risperidone

    Spain

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

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    Rescon USA Summit
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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
    ✖

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

    Issue Date : 2012-07-16

    Type : Chemical

    Substance Number : 1559

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 64567-0003

    Start Marketing Date : 2006-07-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Samoh 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

     VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
    AUDIT
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    07

    Salmeterol Xinafoate

    Spain

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

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    Rescon USA Summit
    Exhibiting
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    Virtual BoothInke S.A: APIs manufacturing plant.
    USDMF arrow-down
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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

     CEP/COS arrow-down
    ✖

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

    Issue Date : 2014-06-16

    Type : Chemical

    Substance Number : 1765

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 64567-0007

    Start Marketing Date : 2008-03-27

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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

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    08

    Tiotropium Bromide

    Spain

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

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    Rescon USA Summit
    Exhibiting
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    Virtual BoothInke S.A: APIs manufacturing plant.
    USDMF arrow-down
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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

     CEP/COS arrow-down
    ✖

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

    Issue Date : 2023-05-16

    Type : Chemical

    Substance Number : 2420

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 64567-0026

    Start Marketing Date : 2021-01-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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

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    09

    Granisetron

    Spain

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

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    Rescon USA Summit
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    Virtual BoothInke S.A: APIs manufacturing plant.
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21790

    Submission : 2008-06-24

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 64567-0010

    Start Marketing Date : 2009-08-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Ondansetron

    Spain

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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16172

    Submission : 2002-09-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 64567-0008

    Start Marketing Date : 2009-08-19

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
    AUDIT
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    Aclidinium Bromide

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-06-14

    Pay. Date : 2023-04-21

    DMF Number : 36437

    Submission : 2023-03-16

    Status : Active

    Type : II

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    Aprepitant

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    Inke S.A

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-05-31

    Pay. Date : 2022-05-16

    DMF Number : 35497

    Submission : 2022-04-26

    Status : Active

    Type : II

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    03

    Arformoterol Tartrate (form A)

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-07-14

    Pay. Date : 2022-03-17

    DMF Number : 36435

    Submission : 2022-05-16

    Status : Active

    Type : II

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    Arformoterol Tartrate (form D)

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2019-04-12

    Pay. Date : 2018-07-17

    DMF Number : 32990

    Submission : 2018-07-25

    Status : Active

    Type : II

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    Clevidipine Butyrate

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-09-02

    Pay. Date : 2022-03-17

    DMF Number : 36436

    Submission : 2022-06-14

    Status : Active

    Type : II

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    06

    Fluconazole

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    Inke S.A

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14714

    Submission : 1999-12-15

    Status : Active

    Type : II

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    07

    Formoterol Fumarate

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-06-16

    Pay. Date : 2017-05-10

    DMF Number : 16628

    Submission : 2003-06-03

    Status : Active

    Type : II

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    Glycopyrrolate

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    Inke S.A

    GDUFA

    DMF Review : Complete

    Rev. Date : 2018-02-16

    Pay. Date : 2017-07-06

    DMF Number : 31836

    Submission : 2017-07-22

    Status : Active

    Type : II

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    09

    Granisetron Base

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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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    10

    Granisetron Hydrochloride

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-12-10

    Pay. Date : 2021-12-07

    DMF Number : 17346

    Submission : 2004-04-05

    Status : Active

    Type : II

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    Enalapril maleate

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    Inke S.A

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

    Status : Valid

    Issue Date : 2019-02-21

    Type : Chemical

    Substance Number : 1420

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    02

    Fluconazole

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    Inke S.A

    Certificate Numbers : R1-CEP 2007-219 - Rev 02

    Status : Valid

    Issue Date : 2019-06-14

    Type : Chemical

    Substance Number : 2287

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    03

    Formoterol fumarate dihydrate

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    Inke S.A

    Certificate Numbers : R1-CEP 2006-024 - Rev 02

    Status : Valid

    Issue Date : 2020-10-15

    Type : Chemical

    Substance Number : 1724

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    04

    Glycopyrronium bromide, Micronised, non-...

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    Inke S.A

    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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    Inke S.A

    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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    Inke S.A

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

    Status : Valid

    Issue Date : 2012-06-20

    Type : Chemical

    Substance Number : 1246

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    07

    Ondansetron hydrochloride dihydrate

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    Inke S.A

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

    Status : Valid

    Issue Date : 2012-05-24

    Type : Chemical

    Substance Number : 2016

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    08

    Risperidone

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    Inke S.A

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

    Status : Valid

    Issue Date : 2012-07-16

    Type : Chemical

    Substance Number : 1559

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    09

    Salmeterol xinafoate

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    Inke S.A

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

    Status : Valid

    Issue Date : 2014-06-16

    Type : Chemical

    Substance Number : 1765

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    10

    Tiotropium bromide monohydrate, Micronis...

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    Inke S.A

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

    Status : Valid

    Issue Date : 2023-05-16

    Type : Chemical

    Substance Number : 2420

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    JDMF

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    Carvedilol

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    Inke S.A

    Registration Number : 218MF10100

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

    Initial Date of Registration : 2006-01-30

    Latest Date of Registration : 2019-07-26

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    02

    Eletriptan hydrobromide

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    Inke S.A

    Registration Number : 229MF10147

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

    Initial Date of Registration : 2017-07-31

    Latest Date of Registration : 2017-07-31

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    Eletriptan Hydrobromide

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    Inke S.A

    Registration Number : 304MF10075

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

    Initial Date of Registration : 2022-05-18

    Latest Date of Registration : 2022-05-18

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    Formoterol fumarate hydrate

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    Inke S.A

    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 : 2022-06-15

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    Granisetron hydrochloride

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    Inke S.A

    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 : 2006-12-01

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    Loratadine

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    Inke S.A

    Registration Number : 222MF10170

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

    Initial Date of Registration : 2010-06-08

    Latest Date of Registration : 2010-06-08

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    07

    Montelukast sodium

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    Inke S.A

    Registration Number : 228MF10055

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

    Initial Date of Registration : 2016-02-18

    Latest Date of Registration : 2016-11-22

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    Montelukast sodium

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    Inke S.A

    Registration Number : 227MF10180

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

    Initial Date of Registration : 2015-07-13

    Latest Date of Registration : 2016-11-22

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    09

    Quetiapine fumarate

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    Inke S.A

    Registration Number : 223MF10034

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

    Initial Date of Registration : 2011-03-09

    Latest Date of Registration : 2011-03-09

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    Telmisartan

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    Inke S.A

    Registration Number : 228MF10056

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

    Initial Date of Registration : 2016-02-18

    Latest Date of Registration : 2016-11-22

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    KDMF

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    Aformoterol tartrate

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    Inke S.A

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2022-03-24

    Registration Number : 20220324-211-J-1236

    Manufacturer Name : INKE, SA

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

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    02

    Enalapril maleate

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    Inke S.A

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

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

    Manufacturer Name : Inke, SA (Group Vita)

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

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    03

    Fluconazole

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    Inke S.A

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-74-A-158-11

    Manufacturer Name : INKE SA

    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 : Samoh 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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    05

    Glycopyrronium bromide

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    Inke S.A

    Registrant Name : Samoh 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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    06

    Granisetron hydrochloride

    Spain
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    Inke S.A

    Registrant Name : Samoh 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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    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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    08

    Indacaterol Maleate

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    Inke S.A

    Registrant Name : Samoh 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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    09

    Olanzapine

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    Inke S.A

    Registrant Name : Samoh 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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    10

    Quetiapine fumarate

    Spain
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    Inke S.A

    Registrant Name : Samoh 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, 108755 CASTELLBISBAL, Barcelona, ​​SPAI...

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    ACLIDINIUM BROMIDE

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    Inke S.A

    NDC Package Code : 64567-0028

    Start Marketing Date : 2022-01-13

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    APREPITANT

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    Inke S.A

    NDC Package Code : 64567-0021

    Start Marketing Date : 2021-01-14

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    ARFORMOTEROL TARTRATE

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    Inke S.A

    NDC Package Code : 64567-0022

    Start Marketing Date : 2021-01-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    ARFORMOTEROL TARTRATE

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    Inke S.A

    NDC Package Code : 64567-0020

    Start Marketing Date : 2018-07-19

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    CLEVIDIPINE

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    Inke S.A

    NDC Package Code : 64567-0023

    Start Marketing Date : 2021-01-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    FLUCONAZOLE

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    Inke S.A

    NDC Package Code : 64567-0002

    Start Marketing Date : 2011-06-07

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    FORMOTEROL FUMARATE

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    Inke S.A

    NDC Package Code : 64567-0006

    Start Marketing Date : 2008-06-17

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    GLYCOPYRROLATE

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    Inke S.A

    NDC Package Code : 64567-0018

    Start Marketing Date : 2017-07-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    GRANISETRON

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    Inke S.A

    NDC Package Code : 64567-0010

    Start Marketing Date : 2009-08-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    GRANISETRON HYDROCHLORIDE

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    Inke S.A

    NDC Package Code : 64567-0009

    Start Marketing Date : 2009-10-28

    End Marketing Date : 2024-12-31

    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.
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    01

    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.

    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.
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    02

    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.

    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.
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    03

    Arformoterol Tartrate

    Spain
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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.

    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.
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    04

    Asenapine Maleate

    Spain
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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.

    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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    Benserazide Hydrochloride

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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.
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    05

    Benserazide Hydrochloride

    Spain
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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.

    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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    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.
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    06

    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.

    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.
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    07

    Clevidipine Butyrate

    Spain
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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.

    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.
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    08

    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.

    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.
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    09

    Daridorexant

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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.

    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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    Eletriptan Hydrobromide

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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.
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    Eletriptan Hydrobromide

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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.

    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).

    Find a price of Formoterol Fumarate bulk with DMF, CEP, JDMF offered by Inke S.A

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    Find a price of Salmeterol Xinafoate bulk with DMF, CEP offered by Inke S.A

    Find a price of Tiotropium Bromide bulk with DMF, CEP offered by Inke S.A

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