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    Company profile for Medichem S.A

    Medichem SA-PSE
    News
    Medichem To Present At Jefferies London Healthcare Conf. 2024

    18 Nov 2024

    // PRESS RELEASE

    Medichem Achieves Progress At New Asturias Injectables Facility

    10 Oct 2024

    // PRESS RELEASE

    Medichem Sustainability Report 2023 – Einf (Non-Financial Information)

    01 Aug 2024

    // PRESS RELEASE

    DATA COMPILATION
    #PharmaFlow

    Medichem

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    Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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    About

    Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.

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    Medichem S.ASpain_new Flag
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    Spain
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    Carrer de Fructuós Gelabert, 608970 Sant Joan Despí, Barcelona
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    +34 934776440
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    enquiries@pharmacompass.com
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    https://www.medichem.es/
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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      https://www.pharmacompass.com/pdf/party/content/medichem-sa-party-content-53030.pdf

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    Corporate Presentation

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    APIs Product List 2024

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    GMP Certificate 2023

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    FDF Product List 2024

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    APIs Under Development 2024

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    Dossiers Under Development 2024

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    APIs Under Consideration 2024

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    Dossiers Under Consideration 2024

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    Chlorhexidine API

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    Chlorhexidine FDF

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    Flow Chemistry

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    DATA COMPILATION #PharmaFlow

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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    24 Oct 2024
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    NEWS #PharmaBuzz

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    Medichem To Present At Jefferies London Healthcare Conf. 2024
    Medichem To Present At Jefferies London Healthcare Conf. 2024

    18 Nov 2024

    // PRESS RELEASE

    https://www.medichem.es/news/medichem-is-proud-to-take-part-in-the-2024-jefferies-london-healthcare-conference/

    PRESS RELEASE
    18 Nov 2024
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    Medichem Achieves Progress At New Asturias Injectables Facility
    Medichem Achieves Progress At New Asturias Injectables Facility

    10 Oct 2024

    // PRESS RELEASE

    https://www.medichem.es/news/medichem-solutions-completes-key-milestones-at-new-injectables-plant-in-asturias/

    PRESS RELEASE
    10 Oct 2024
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    Medichem Sustainability Report 2023 – Einf (Non-Financial Information)
    Medichem Sustainability Report 2023 – Einf (Non-Financial Information)

    01 Aug 2024

    // PRESS RELEASE

    https://www.medichem.es/news/medichem-sustainability-report-2023-einf-non-financial-information/

    PRESS RELEASE
    01 Aug 2024
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    Join Medichem At Cphi Worldwide 2024: High-Quality APIs &FDFs
    Join Medichem At Cphi Worldwide 2024: High-Quality APIs &FDFs

    26 Jul 2024

    // PRESS RELEASE

    https://www.medichem.es/news/join-medichem-at-cphi-worldwide-2024-your-gateway-to-high-quality-apis-and-fdfs/

    PRESS RELEASE
    26 Jul 2024
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    En Medichem Renovamos La Carta De Diversidad
    En Medichem Renovamos La Carta De Diversidad

    21 Jun 2024

    // PRESS RELEASE

    https://www.medichem.es/news/en-medichem-renovamos-la-carta-de-diversidad/

    PRESS RELEASE
    21 Jun 2024
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    Medichem En El Programa Dona’M Ciència
    Medichem En El Programa Dona’M Ciència

    17 Jun 2024

    // PRESS RELEASE

    https://www.medichem.es/news/medichem-en-el-programa-donam-ciencia/

    PRESS RELEASE
    17 Jun 2024
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    ALL APIs

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    01

    Clozapine

    Spain

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-01-29

    Pay. Date : 2015-01-26

    DMF Number : 10534

    Submission : 1993-10-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-151 - Rev 00

    Issue Date : 2015-07-13

    Type : Chemical

    Substance Number : 1191

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10021

    Registrant's Address : 6-8, Fructo(´)s Gelabert 08970 Sant Joan Despi(´)(Barcelona) Spain

    Initial Date of Registration : 2019-06-25

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53296-0033

    Start Marketing Date : 2010-03-22

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (75kg/75kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hwanin Pharmaceutical Co., Ltd.

    Registration Date : 2020-05-04

    Registration Number : 20180903-209-J-157(2)

    Manufacturer Name : Medichem SA

    Manufacturer Address : Poligon Industrial de Celra 17460 CELRA (Girona), Spain

     VMF Others AUDIT
    Medichem

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Brimonidine Tartrate

    Spain

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-23

    DMF Number : 15601

    Submission : 2001-08-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-353 - Rev 00

    Issue Date : 2019-04-24

    Type : Chemical

    Substance Number : 2760

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53296-0050

    Start Marketing Date : 2014-09-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (75kg/75kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hansol Pharma Co., Ltd.

    Registration Date : 2024-05-01

    Registration Number : 20141201-200-I-451-04(1)

    Manufacturer Name : MEDICHEM SA

    Manufacturer Address : Pirineus street, 127, Poligon Industrial de Celra, 17460 Celra (Girona), Spain

     VMF Others AUDIT
    Medichem

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    03

    Chlorhexidine Gluconate

    Spain

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-10-27

    Pay. Date : 2017-10-04

    DMF Number : 25149

    Submission : 2011-07-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1993-009 - Rev 04

    Issue Date : 2009-02-16

    Type : Chemical

    Substance Number : 658

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Medichem

    Product
    Web Link

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    #PipelineProspector

    Market
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    04

    Chlorhexidine Hydrochloride

    Spain

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17143

    Submission : 2004-02-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-081 - Rev 02

    Issue Date : 2024-02-19

    Type : Chemical

    Substance Number : 659

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53296-0011

    Start Marketing Date : 2010-03-15

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (75kg/75kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Medichem

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    05

    Felodipine

    Spain

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-28

    Pay. Date : 2013-03-14

    DMF Number : 14099

    Submission : 1999-05-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-213 - Rev 01

    Issue Date : 2012-05-18

    Type : Chemical

    Substance Number : 1013

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53296-0041

    Start Marketing Date : 2010-04-02

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (75kg/75kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Medichem

    Product
    Web Link

    Stock Recap
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    Market
    Place

    06

    Mirtazapine

    Spain

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-30

    Pay. Date : 2013-04-17

    DMF Number : 15749

    Submission : 2001-12-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-178 - Rev 00

    Issue Date : 2013-09-05

    Type : Chemical

    Substance Number : 2338

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53296-0047

    Start Marketing Date : 2010-05-13

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (75kg/75kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2022-02-04

    Registration Number : 20220204-209-J-1227

    Manufacturer Name : MEDICHEM SA

    Manufacturer Address : Pirineus street, 127, Poligon Industrial de Celra, 17460 Celra (Girona), Spain

     VMF Others AUDIT
    Medichem

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Paroxetine Hydrochloride

    Spain

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-10-08

    Pay. Date : 2015-09-14

    DMF Number : 18052

    Submission : 2005-02-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-200 - Rev 00

    Issue Date : 2018-03-05

    Type : Chemical

    Substance Number : 2018

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53296-0057

    Start Marketing Date : 2010-05-14

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (75kg/75kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Medichem

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Quetiapine Hemifumarate

    Spain

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-02-25

    Pay. Date : 2014-12-05

    DMF Number : 28833

    Submission : 2014-12-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-081 - Rev 01

    Issue Date : 2023-12-12

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 16436-0061

    Start Marketing Date : 2010-06-03

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (75kg/75kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Medichem

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Rivaroxaban

    Spain

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-05-15

    Pay. Date : 2014-12-23

    DMF Number : 28916

    Submission : 2014-12-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-005 - Rev 01

    Issue Date : 2024-01-04

    Type : Chemical

    Substance Number : 2932

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 16436-0109

    Start Marketing Date : 2011-12-20

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (75kg/75kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : YuYu Pharmaceutical Co., Ltd.

    Registration Date : 2019-10-10

    Registration Number : No. 133-7-ND(1)

    Manufacturer Name : Medichem Manufacturing (Malta) Ltd.

    Manufacturer Address : HF 61 Hal Far Industrial Estate, Birzebbugia BBG 3000, Malta

     VMF Others AUDIT
    Medichem

    Product
    Web Link

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    Market
    Place

    10

    Sugammadex Sodium

    Spain

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-09-10

    Pay. Date : 2019-06-19

    DMF Number : 33874

    Submission : 2019-06-17

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10019

    Registrant's Address : HF61, Hal Far Industrial Estate Hal Far, BBG3000. Malta

    Initial Date of Registration : 2023-02-02

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 16436-0119

    Start Marketing Date : 2017-11-27

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (75kg/75kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2021-01-28

    Registration Number : Number 133-11-ND

    Manufacturer Name : Medichem Manufacturing (Malta) Ltd

    Manufacturer Address : HF 61 Hal Far Industrial Estate, Birzebbugia BBG 3000, Malta

     VMF Others AUDIT
    Medichem

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    USDMF

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    01

    Adapalene (med-200025/e)

    Spain
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    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-05-09

    Pay. Date : 2013-04-25

    DMF Number : 21480

    Submission : 2008-03-26

    Status : Active

    Type : II

    Medichem

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    02

    Ambrisentan (med-200028/m)

    Spain
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-12-18

    Pay. Date : 2014-11-19

    DMF Number : 28781

    Submission : 2014-11-18

    Status : Active

    Type : II

    Medichem

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    03

    Amoxapine

    Spain
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    Medichem S.A

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 6887

    Submission : 1987-03-16

    Status : Active

    Type : II

    Medichem

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    04

    Apixaban

    Spain
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    Medichem S.A

    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-09-20

    Pay. Date : 2016-06-30

    DMF Number : 30646

    Submission : 2016-06-30

    Status : Active

    Type : II

    Medichem

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    05

    Brimonidine Tartrate

    Spain
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    Not Confirmed
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    Medichem S.A

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-23

    DMF Number : 15601

    Submission : 2001-08-27

    Status : Active

    Type : II

    Medichem

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    06

    Captopril

    Spain
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    Not Confirmed
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    GDUFA

    DMF Review : Complete

    Rev. Date : 2018-01-19

    Pay. Date : 2017-12-05

    DMF Number : 32247

    Submission : 2017-12-04

    Status : Active

    Type : II

    Medichem

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    07

    Chlorhexidine Acetate

    Spain
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    Not Confirmed
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 9573

    Submission : 1992-03-10

    Status : Active

    Type : II

    Medichem

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    08

    Chlorhexidine Base

    Spain
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    Antibody Engineering
    Not Confirmed
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 6711

    Submission : 1986-12-02

    Status : Active

    Type : II

    Medichem

    Product
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    09

    Chlorhexidine Dihydrochloride

    Spain
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    Antibody Engineering
    Not Confirmed
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17143

    Submission : 2004-02-04

    Status : Active

    Type : II

    Medichem

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    10

    Chlorhexidine Gluconate

    Spain
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    Antibody Engineering
    Not Confirmed
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-11

    Pay. Date : 2012-12-06

    DMF Number : 9701

    Submission : 1992-05-27

    Status : Active

    Type : II

    Medichem

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    KDMF

    read-more
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    01

    Apixaban

    Spain
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    Antibody Engineering
    Not Confirmed
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    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2019-11-26

    Registration Number : Su133-10-ND

    Manufacturer Name : Medichem Manufacturing (Malta)...

    Manufacturer Address : HF-61 Hal Far Industrial Estate, Birzebbugia BBG 3000, Malta

    Medichem

    Product
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    02

    Brimonidine tartrate

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2014-12-01

    Registration Number : 20141201-200-I-451-04

    Manufacturer Name : MEDICHEM SA

    Manufacturer Address : Pirineus street, 127, Poligon Industrial de Celra, 17460 Celra (Girona), Spain

    Medichem

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    03

    Brimonidine tartrate

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
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    • EDQM
    • WHO-GMP
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    Registrant Name : Hansol Pharma Co., Ltd.

    Registration Date : 2024-05-01

    Registration Number : 20141201-200-I-451-04(1)

    Manufacturer Name : MEDICHEM SA

    Manufacturer Address : Pirineus street, 127, Poligon Industrial de Celra, 17460 Celra (Girona), Spain

    Medichem

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    04

    Clozapine

    Spain
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    Registrant Name : Hwanin Pharmaceutical Co., Ltd.

    Registration Date : 2020-05-04

    Registration Number : 20180903-209-J-157(2)

    Manufacturer Name : Medichem SA

    Manufacturer Address : Poligon Industrial de Celra 17460 CELRA (Girona), Spain

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    05

    Clozapine

    Spain
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    Registrant Name : Dongwha Pharmaceutical Co., Ltd.

    Registration Date : 2018-10-23

    Registration Number : 20180903-209-J-157(1)

    Manufacturer Name : Medichem SA

    Manufacturer Address : Poligon Industrial de Celra 17460

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    06

    Clozapine

    Spain
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2018-09-03

    Registration Number : 20180903-209-J-157

    Manufacturer Name : Medichem SA

    Manufacturer Address : Poligon Industrial de Celra 17460 CELRA (Girona), Spain

    Medichem

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    07

    Glimepiride

    Spain
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2007-12-28

    Registration Number : 20071228-78-D-30-09

    Manufacturer Name : Medichem SA

    Manufacturer Address : Pollgono Industrial de Celra 17460 Celra. Girona.Spain

    Medichem

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    08

    Mirtazapine

    Spain
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2022-02-04

    Registration Number : 20220204-209-J-1227

    Manufacturer Name : MEDICHEM SA

    Manufacturer Address : Pirineus street, 127, Poligon Industrial de Celra, 17460 Celra (Girona), Spain

    Medichem

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    09

    Octenidine Hydrochloride

    Spain
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2022-11-28

    Registration Number : Number 207-58-ND

    Manufacturer Name : Medichem SA

    Manufacturer Address : Polígono Industrial de Celrà 17460 Celrà (Girona) SPAIN

    Medichem

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    10

    Olopatadine hydrochloride

    Spain
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Medichem S.A

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2021-04-29

    Registration Number : 20210429-209-J-964

    Manufacturer Name : Medichem SA

    Manufacturer Address : Poligon Industrial de Celra 17460 Celra (GIRONA), Spain

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    Services

    Discover the service capabilities from this company

    API Manufacturing

    Discover their expertise for : API Manufacturing

    Sales, Marketing, Registration

    Discover their expertise for : Sales, Marketing, Registration

    Packaging

    Discover their expertise for : Packaging

    Inspections and registrations

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    Others

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    ABOUT THIS PAGE

    Contact Medichem S.A and get a quotation

    Medichem S.A is a supplier offers 73 products (APIs, Excipients or Intermediates).

    Find a price of Clozapine bulk with DMF, CEP, JDMF offered by Medichem S.A

    Find a price of Brimonidine Tartrate bulk with DMF, CEP offered by Medichem S.A

    Find a price of Chlorhexidine Acetate bulk with DMF, CEP offered by Medichem S.A

    Find a price of Chlorhexidine Gluconate bulk with DMF, CEP offered by Medichem S.A

    Find a price of Chlorhexidine Hydrochloride bulk with DMF, CEP offered by Medichem S.A

    Find a price of Felodipine bulk with DMF, CEP offered by Medichem S.A

    Find a price of Mirtazapine bulk with DMF, CEP offered by Medichem S.A

    Find a price of Paroxetine Hydrochloride bulk with DMF, CEP offered by Medichem S.A

    Find a price of Quetiapine Hemifumarate bulk with DMF, CEP offered by Medichem S.A

    Find a price of Rivaroxaban bulk with DMF, CEP offered by Medichem S.A

    Find a price of Sugammadex Sodium bulk with DMF, JDMF offered by Medichem S.A

    Find a price of Voriconazole bulk with DMF, CEP offered by Medichem S.A

    Find a price of Adapalene bulk with DMF offered by Medichem S.A

    Find a price of Alendronate Sodium bulk with CEP offered by Medichem S.A

    Find a price of Ambrisentan bulk with DMF offered by Medichem S.A

    Find a price of Amoxapine bulk with DMF offered by Medichem S.A

    Find a price of Apixaban bulk with DMF offered by Medichem S.A

    Find a price of Asenapine Maleate bulk with DMF offered by Medichem S.A

    Find a price of Captopril bulk with DMF offered by Medichem S.A

    Find a price of Chlorhexidine bulk with DMF offered by Medichem S.A

    Find a price of Cinacalcet Hydrochloride bulk with DMF offered by Medichem S.A

    Find a price of Cyclobenzaprine bulk with DMF offered by Medichem S.A

    Find a price of Desvenlafaxine Succinate bulk with DMF offered by Medichem S.A

    Find a price of Edaravone bulk with DMF offered by Medichem S.A

    Find a price of Enalapril Maleate bulk with DMF offered by Medichem S.A

    Find a price of Fluvoxamine bulk with DMF offered by Medichem S.A

    Find a price of Gabapentin bulk with CEP offered by Medichem S.A

    Find a price of Guanfacine bulk with DMF offered by Medichem S.A

    Find a price of Lamotrigine bulk with DMF offered by Medichem S.A

    Find a price of Lofexidine bulk with DMF offered by Medichem S.A

    Find a price of Loxapine bulk with DMF offered by Medichem S.A

    Find a price of Loxapine Succinate bulk with DMF offered by Medichem S.A

    Find a price of Mexiletine bulk with DMF offered by Medichem S.A

    Find a price of Micafungin bulk with DMF offered by Medichem S.A

    Find a price of Nepafenac bulk with DMF offered by Medichem S.A

    Find a price of Olopatadine Hydrochloride bulk with DMF offered by Medichem S.A

    Find a price of Pantoprazole Sodium bulk with CEP offered by Medichem S.A

    Find a price of Pazopanib Hydrochloride bulk with DMF offered by Medichem S.A

    Find a price of Pimecrolimus bulk with DMF offered by Medichem S.A

    Find a price of Prucalopride Succinate bulk with DMF offered by Medichem S.A

    Find a price of Revefenacin bulk with DMF offered by Medichem S.A

    Find a price of Risperidone bulk with CEP offered by Medichem S.A

    Find a price of Solifenacin Succinate bulk with CEP offered by Medichem S.A

    Find a price of Sunitinib bulk with DMF offered by Medichem S.A

    Find a price of Tamsulosin bulk with DMF offered by Medichem S.A

    Find a price of Venlafaxine Hydrochloride bulk with CEP offered by Medichem S.A

    Find a price of Voclosporin bulk with DMF offered by Medichem S.A

    Find a price of VARENICLINE TARTRATE (MED-201890/E) bulk with DMF offered by Medichem S.A

    Find a price of Rivaroxaban, RVXN bulk with CEP offered by Medichem S.A

    Find a price of Amikacin bulk offered by Medichem S.A

    Find a price of Buprenorphine bulk offered by Medichem S.A

    Find a price of Cenobamate bulk offered by Medichem S.A

    Find a price of Disodium Hydrogen Phosphate bulk offered by Medichem S.A

    Find a price of Elexacaftor bulk offered by Medichem S.A

    Find a price of Encorafenib bulk offered by Medichem S.A

    Find a price of Ivacaftor bulk offered by Medichem S.A

    Find a price of Levoketoconazole bulk offered by Medichem S.A

    Find a price of Lorlatinib bulk offered by Medichem S.A

    Find a price of Lumacaftor bulk offered by Medichem S.A

    Find a price of Lumateperone Tosylate bulk offered by Medichem S.A

    Find a price of Naloxone Hydrochloride bulk offered by Medichem S.A

    Find a price of Naltrexone bulk offered by Medichem S.A

    Find a price of Octenidine Hydrochloride bulk offered by Medichem S.A

    Find a price of Opicapone bulk offered by Medichem S.A

    Find a price of Potassium Phosphate bulk offered by Medichem S.A

    Find a price of Rasagiline Tartrate bulk offered by Medichem S.A

    Find a price of Relugolix bulk offered by Medichem S.A

    Find a price of Rimegepant Sulfate bulk offered by Medichem S.A

    Find a price of Ruxolitinib Phosphate bulk offered by Medichem S.A

    Find a price of Tezacaftor bulk offered by Medichem S.A

    Find a price of Varenicline Tartrate bulk offered by Medichem S.A

    Find a price of Vibegron bulk offered by Medichem S.A

    Find a price of Zanubrutinib bulk offered by Medichem S.A

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