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    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    About

    With over 85 years of experience, Uquifa provides comprehensive services supporting projects from proof of concept to commercial manufacturing. Uquifa’s business model is built on a quality manufacturing platform and a strong track record of service and reliability. Uquifa Group manufactures Active Pharmaceutical Ingredients (APIs) and intermediates for the global pharmaceutical and animal health industries.

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    UQUIFASpain_new Flag
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    Spain
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    C/ Mallorca 262, 3rd floor, Barcelona 08008
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    +34 934 674 810
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

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    16 Dec 2024
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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    21 Nov 2024
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    NEWS #PharmaBuzz

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    Uquifa awarded with EcoVadis Silver Medal
    Uquifa awarded with EcoVadis Silver Medal

    11 Nov 2024

    // PRESS RELEASE

    https://uquifa.com/2024/11/11/uquifa-awarded-with-the-ecovadis-silver-medal/

    PRESS RELEASE
    11 Nov 2024
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    Driving innovation in API Synthesis
    Driving innovation in API Synthesis

    24 Oct 2024

    // PRESS RELEASE

    https://uquifa.com/2024/10/24/driving-innovation-in-api-synthesis/

    PRESS RELEASE
    24 Oct 2024
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    A word with Saurabh Gurnurkar - Chimica Oggi
    A word with Saurabh Gurnurkar - Chimica Oggi

    14 Oct 2024

    // PRESS RELEASE

    https://uquifa.com/2024/10/14/uquifa-cphi-milano-2024/

    PRESS RELEASE
    14 Oct 2024
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    Applying Agile methodologies in CDMOs
    Applying Agile methodologies in CDMOs

    14 May 2021

    // EXPRESS PHARMA

    https://www.expresspharma.in/applying-agile-methodologies-in-cdmos/

    EXPRESS PHARMA
    14 May 2021
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    External Communication - Covid-19
    External Communication - Covid-19

    15 Mar 2021

    // PRESS RELEASE

    http://www.uquifa.com/en/news/267-external-communication-covic-19

    PRESS RELEASE
    15 Mar 2021
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    Esteve and Uquifa are involved in the manufacture of Remdesivir
    Esteve and Uquifa are involved in the manufacture of Remdesivir

    24 Jul 2020

    // ELNACIONAL

    https://www.elnacional.cat/ca/salut/esteve-uquifa-participen-fabricacio-remdesivir-gilead_525204_102.html

    ELNACIONAL
    24 Jul 2020
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    ALL APIs

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    01

    Ciprofloxacin

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

    Antibody Engineering
    Not Confirmed
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    Ciprofloxacin

    Spain

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

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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17279

    Submission : 2004-03-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2004-173 - Rev 01

    Issue Date : 2024-02-15

    Type : Chemical

    Substance Number : 1089

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10080

    Registrant's Address : Calle 37 Este No. 126, CIVAC, 62578, Jiutepec, Morelos, Mexico

    Initial Date of Registration : 2007-03-14

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52286-0014

    Start Marketing Date : 2009-11-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2011-07-15

    Registration Number : 20110715-85-D-103-18

    Manufacturer Name : Uquifa Mexico SAde CV

    Manufacturer Address : Calle 37 Este No 126, CIVAC, Jiutepec, Morelos CP 62578, Mexico

     VMF Others AUDIT
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    02

    Clindamycin Phosphate

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

    Antibody Engineering
    Not Confirmed
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    Clindamycin Phosphate

    Spain

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

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    Antibody Engineering
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-12

    Pay. Date : 2013-01-23

    DMF Number : 14412

    Submission : 1999-09-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-097 - Rev 05

    Issue Date : 2023-06-09

    Type : Chemical

    Substance Number : 996

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10069

    Registrant's Address : Mallorca, 262, 3rd floor 08008 Barcelona Spain

    Initial Date of Registration : 2014-03-11

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 49711-0116

    Start Marketing Date : 2009-10-22

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Ketoconazole

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

    Antibody Engineering
    Not Confirmed
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    Ketoconazole

    Spain

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

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    Antibody Engineering
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-10-03

    Pay. Date : 2019-09-27

    DMF Number : 16212

    Submission : 2002-10-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-138 - Rev 04

    Issue Date : 2021-04-21

    Type : Chemical

    Substance Number : 921

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10434

    Registrant's Address : Calle 37 Este No. 126, CIVAC, 62578, Jiutepec, Morelos, Mexico

    Initial Date of Registration : 2006-04-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52286-0009

    Start Marketing Date : 2009-11-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    Lansoprazole

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

    Antibody Engineering
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    Lansoprazole

    Spain

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

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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17787

    Submission : 2004-10-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-001 - Rev 00

    Issue Date : 2019-04-24

    Type : Chemical

    Substance Number : 2219

    Status : Valid

     JDMF arrow-down
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    Registration Number : 220MF10103

    Registrant's Address : Mallorca, 262, 3rd floor 08008 Barcelona Spain

    Initial Date of Registration : 2008-04-11

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 49711-0110

    Start Marketing Date : 2009-10-23

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2013-05-03

    Registration Number : 20130503-3-B-348-15

    Manufacturer Name : UNION QUIMICO FARMACEUTICA, SA

    Manufacturer Address : Poligon Industrial Moli de les Planes; Calle Font de Bocs s/n; C-35, Km 57, Sant Celoni 08470 (Barcelona), Spain

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    05

    Metformin

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

    Antibody Engineering
    Not Confirmed
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    Metformin

    Spain

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16047

    Submission : 2002-07-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-063 - Rev 03

    Issue Date : 2020-10-29

    Type : Chemical

    Substance Number : 931

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10080

    Registrant's Address : Calle 37 Este No. 126, CIVAC, 62578, Jiutepec, Morelos, Mexico

    Initial Date of Registration : 2024-06-18

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52286-0008

    Start Marketing Date : 2009-11-04

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2013-10-21

    Registration Number : 20050831-37-C-41-09(4)

    Manufacturer Name : Uquifa Mexico SA of CV

    Manufacturer Address : Calle 37 Este No.126, Cuidad Industrial del Valle de Cuernavaca (CIVAC), Jiutepec, Morelos CP 62578

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    06

    Omeprazole

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

    Antibody Engineering
    Not Confirmed
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    Omeprazole

    Spain

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

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11551

    Submission : 1995-06-09

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-120 - Rev 00

    Issue Date : 2022-09-26

    Type : Chemical

    Substance Number : 942

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10283

    Registrant's Address : Torre Esteve, Pg. de la Zona Franca, 109, 4th floor, 08038 Barcelona - Spain

    Initial Date of Registration : 2007-09-10

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 49711-0109

    Start Marketing Date : 2009-10-26

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Chong Kun Dang Co., Ltd.

    Registration Date : 2015-03-10

    Registration Number : 20050831-52-B-137-02(1)

    Manufacturer Name : Esteve Quimica, SA

    Manufacturer Address : Poli Industrial El Pla Av. Puigcerda, 9C-17, km 17.4 08185 Llica de Vall (Barcelona) Spain

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    07

    Aciclovir

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

    Antibody Engineering
    Not Confirmed
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    Aciclovir

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-05-09

    Pay. Date : 2013-04-26

    DMF Number : 11896

    Submission : 1996-03-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-148 - Rev 05

    Issue Date : 2016-12-08

    Type : Chemical

    Substance Number : 968

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 49711-0094

    Start Marketing Date : 2009-10-21

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Shinil Pharmaceutical Co., Ltd.

    Registration Date : 2020-06-16

    Registration Number : 20050831-33-A-77-05(3)

    Manufacturer Name : Union Quimico Farmaceutica SA

    Manufacturer Address : Poligon Industrial Moli de les Planes Font de Bocs S/N C-35, Km. 57 08470 Sant Celoni (Barcelona) Spain

     VMF Others AUDIT
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    08

    Allopurinol

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

    Antibody Engineering
    Not Confirmed
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    Allopurinol

    Spain

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

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    Antibody Engineering
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-12-29

    Pay. Date : 2017-12-06

    DMF Number : 16472

    Submission : 2003-03-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-004 - Rev 02

    Issue Date : 2017-12-15

    Type : Chemical

    Substance Number : 576

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 49711-0113

    Start Marketing Date : 2009-10-22

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Cimetidine

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

    Antibody Engineering
    Not Confirmed
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    Cimetidine

    Spain

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

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    Antibody Engineering
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-07-15

    Pay. Date : 2021-07-12

    DMF Number : 10982

    Submission : 1994-07-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-023 - Rev 06

    Issue Date : 2019-09-03

    Type : Chemical

    Substance Number : 756

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 49711-0095

    Start Marketing Date : 2009-10-22

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Pavise Pharmaceutical Co., Ltd.

    Registration Date : 2020-07-17

    Registration Number : 20060302-27-B-229-04(14)

    Manufacturer Name : Union quimico farmaceutica, SA

    Manufacturer Address : Poligon Industrial Moli de Planes Font de Bocs S/N C-35, Km. 5708470 Sant Celoni. Barcelona, ​​Spain

     VMF Others AUDIT
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    10

    Nimodipine

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

    Antibody Engineering
    Not Confirmed
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    Nimodipine

    Spain

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-05-31

    Pay. Date : 2018-05-10

    DMF Number : 16951

    Submission : 2003-11-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2004-272 - Rev 03

    Issue Date : 2023-10-04

    Type : Chemical

    Substance Number : 1245

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 49711-0104

    Start Marketing Date : 2009-10-23

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    2-isopropyl-4-(n-methyl) Aminomethyl...

    Spain
    Antibody Engineering
    Not Confirmed
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    02

    2-isopropyl-4-(n-methyl) Amninomethy...

    Spain
    Antibody Engineering
    Not Confirmed
    arrow

    03

    Acyclovir

    Spain
    Antibody Engineering
    Not Confirmed
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    Acyclovir

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    UQUIFA

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-05-09

    Pay. Date : 2013-04-26

    DMF Number : 11896

    Submission : 1996-03-18

    Status : Active

    Type : II

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    Market
    Place

    04

    Ag 1346

    Spain
    Antibody Engineering
    Not Confirmed
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    05

    Albendazole

    Spain
    Antibody Engineering
    Not Confirmed
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    Albendazole

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    UQUIFA

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-10-20

    Pay. Date : 2014-08-04

    DMF Number : 25914

    Submission : 2012-03-27

    Status : Active

    Type : II

    blank

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    #PipelineProspector

    Market
    Place

    06

    Allopurinol

    Spain
    Antibody Engineering
    Not Confirmed
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    Allopurinol

    Spain
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    UQUIFA

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-12-29

    Pay. Date : 2017-12-06

    DMF Number : 16472

    Submission : 2003-03-19

    Status : Active

    Type : II

    blank

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    #PipelineProspector

    Market
    Place

    07

    Bicalutamide

    Spain
    Antibody Engineering
    Not Confirmed
    arrow

    08

    Bupropion Hydrochloride Usp

    Spain
    Antibody Engineering
    Not Confirmed
    arrow

    09

    Carisoprodol

    Spain
    Antibody Engineering
    Not Confirmed
    arrow

    10

    Carisoprodol Usp

    Spain
    Antibody Engineering
    Not Confirmed
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    CEP/COS

    read-more
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    01

    Aciclovir

    CEP/COS

    Antibody Engineering
    Not Confirmed
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    02

    Allopurinol

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    03

    Carisoprodol - Monograph Text deleted 01...

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    04

    Cimetidine

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    05

    Ciprofloxacin

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    06

    Clindamycin phosphate

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    07

    Clindamycin phosphate, Product code numb...

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    08

    Doxylamine hydrogen succinate

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    09

    Duloxetine hydrochloride

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    10

    Duloxetine hydrochloride, Process B

    CEP/COS

    Antibody Engineering
    Not Confirmed
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    JDMF

    read-more
    read-more

    01

    Ciprofloxacin

    JDMF

    Antibody Engineering
    Not Confirmed
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    Ciprofloxacin

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
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    UQUIFA

    Registration Number : 219MF10080

    Registrant's Address : Calle 37 Este No. 126, CIVAC, 62578, Jiutepec, Morelos, Mexico

    Initial Date of Registration : 2007-03-14

    Latest Date of Registration : 2007-03-14

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    Market
    Place

    02

    Clindamycin phosphate ester hydrate

    JDMF

    Antibody Engineering
    Not Confirmed
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    Clindamycin phosphate ester hydrate

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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    UQUIFA

    Registration Number : 226MF10069

    Registrant's Address : Mallorca, 262, 3rd floor 08008 Barcelona Spain

    Initial Date of Registration : 2014-03-11

    Latest Date of Registration : 2023-08-09

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    Market
    Place

    03

    Ketoconazole

    JDMF

    Antibody Engineering
    Not Confirmed
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    Ketoconazole

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    UQUIFA

    Registration Number : 218MF10434

    Registrant's Address : Calle 37 Este No. 126, CIVAC, 62578, Jiutepec, Morelos, Mexico

    Initial Date of Registration : 2006-04-27

    Latest Date of Registration : 2020-10-29

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    Market
    Place

    04

    Lansoprazole

    JDMF

    Antibody Engineering
    Not Confirmed
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    Lansoprazole

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    UQUIFA

    Registration Number : 220MF10103

    Registrant's Address : Mallorca, 262, 3rd floor 08008 Barcelona Spain

    Initial Date of Registration : 2008-04-11

    Latest Date of Registration : 2011-03-10

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    Market
    Place

    05

    Metformin Hydrochloride

    JDMF

    Antibody Engineering
    Not Confirmed
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    Metformin Hydrochloride

    Spain
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    UQUIFA

    Registration Number : 306MF10080

    Registrant's Address : Calle 37 Este No. 126, CIVAC, 62578, Jiutepec, Morelos, Mexico

    Initial Date of Registration : 2024-06-18

    Latest Date of Registration : 2024-06-18

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    Market
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    06

    Omeprazole (production only)

    JDMF

    Antibody Engineering
    Not Confirmed
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    Omeprazole (production only)

    Spain
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    Antibody Engineering
    Not Confirmed
    • fda
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    UQUIFA

    Registration Number : 219MF10283

    Registrant's Address : Torre Esteve, Pg. de la Zona Franca, 109, 4th floor, 08038 Barcelona - Spain

    Initial Date of Registration : 2007-09-10

    Latest Date of Registration : 2020-06-08

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    Market
    Place

    07

    Omeprazole sodium (production only)

    JDMF

    Antibody Engineering
    Not Confirmed
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    Omeprazole sodium (production only)

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
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    UQUIFA

    Registration Number : 221MF10170

    Registrant's Address : Torre Esteve, Pg. de la Zona Franca, 109, 4th floor, 08038 Barcelona - Spain

    Initial Date of Registration : 2009-07-30

    Latest Date of Registration : 2011-10-14

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    Market
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    08

    Terbinafine HCl

    JDMF

    Antibody Engineering
    Not Confirmed
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    Terbinafine HCl

    Spain
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    Antibody Engineering
    Not Confirmed
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    UQUIFA

    Registration Number : 218MF10711

    Registrant's Address : Calle 37 Este No. 126, CIVAC, 62578, Jiutepec, Morelos, Mexico

    Initial Date of Registration : 2006-08-14

    Latest Date of Registration : 2013-11-14

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    KDMF

    read-more
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    01

    Acyclovir

    Spain
    Antibody Engineering
    Not Confirmed
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    Acyclovir

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
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    UQUIFA

    Registrant Name : SK Chemical Co., Ltd.

    Registration Date : 2012-06-08

    Registration Number : 20050831-33-A-77-05(1)

    Manufacturer Name : Union Quimico Farmaceutica, SA

    Manufacturer Address : Poligon Industrial Moli de les Planes Font de Bocs S/N C-35, Km.57 08470 Sant Celoni ...

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    Market
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    02

    Acyclovir

    Spain
    Antibody Engineering
    Not Confirmed
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    Acyclovir

    Spain
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    UQUIFA

    Registrant Name : Shinil Pharmaceutical Co., Ltd.

    Registration Date : 2020-06-16

    Registration Number : 20050831-33-A-77-05(3)

    Manufacturer Name : Union Quimico Farmaceutica SA

    Manufacturer Address : Poligon Industrial Moli de les Planes Font de Bocs S/N C-35, Km. 57 08470 Sant Celoni...

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    Market
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    03

    Acyclovir

    Spain
    Antibody Engineering
    Not Confirmed
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    Acyclovir

    Spain
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    Antibody Engineering
    Not Confirmed
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    UQUIFA

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2013-10-20

    Registration Number : 20050831-33-A-77-05(2)

    Manufacturer Name : Union Quimico Farmaceutica, SA

    Manufacturer Address : Poligon Industrial Moli de les Planes Font de Bocs S/N C-35, Km. 57 08470 Sant Celoni...

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    Market
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    04

    Acyclovir

    Spain
    Antibody Engineering
    Not Confirmed
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    Acyclovir

    Spain
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    Antibody Engineering
    Not Confirmed
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    UQUIFA

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-33-A-77-05

    Manufacturer Name : Union quimco farmaceutica, SA

    Manufacturer Address : Poligon Industrial Moli de les Planes Font de Bocs S/N C-35, Km. 57 08470 Sant Celoni...

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    05

    Cimetidine

    Spain
    Antibody Engineering
    Not Confirmed
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    Cimetidine

    Spain
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    Antibody Engineering
    Not Confirmed
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    UQUIFA

    Registrant Name : Hyons Co., Ltd.

    Registration Date : 2020-04-24

    Registration Number : 20060302-27-B-229-04(13)

    Manufacturer Name : Union Quimico Farmaceutica SA

    Manufacturer Address : Poligon Industrial Moli de les Planes, Font de Bocs, S/N, C-35, Km.57 08470 Sant Celo...

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    06

    Cimetidine

    Spain
    Antibody Engineering
    Not Confirmed
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    Cimetidine

    Spain
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    Antibody Engineering
    Not Confirmed
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    UQUIFA

    Registrant Name : Korea Pavise Pharmaceutical Co., Ltd.

    Registration Date : 2020-07-17

    Registration Number : 20060302-27-B-229-04(14)

    Manufacturer Name : Union quimico farmaceutica, SA

    Manufacturer Address : Poligon Industrial Moli de Planes Font de Bocs S/N C-35, Km. 5708470 Sant Celoni. Bar...

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    Market
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    07

    Cimetidine

    Spain
    Antibody Engineering
    Not Confirmed
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    Cimetidine

    Spain
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    Antibody Engineering
    Not Confirmed
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    UQUIFA

    Registrant Name : International Pharmaceutical Co., Ltd.

    Registration Date : 2019-09-24

    Registration Number : 20060302-27-B-229-04(11)

    Manufacturer Name : Union Quimico Farmaceutica SA

    Manufacturer Address : Poligon Industrial Moli de les Planes Font de Bocs S/N C-35, Km. 57 08470 Sant Celoni...

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    08

    Cimetidine

    Spain
    Antibody Engineering
    Not Confirmed
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    Cimetidine

    Spain
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    Antibody Engineering
    Not Confirmed
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    UQUIFA

    Registrant Name : JDW Pharmaceutical Co., Ltd.

    Registration Date : 2019-04-09

    Registration Number : 20060302-27-B-229-04(10)

    Manufacturer Name : Union quimico farmaceutica, SA

    Manufacturer Address : Poligon Industrial Moli de Planes Font de Bocs S/N C-35, Km. 5708470 Sant Celoni. Bar...

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    09

    Cimetidine

    Spain
    Antibody Engineering
    Not Confirmed
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    Cimetidine

    Spain
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    Antibody Engineering
    Not Confirmed
    • fda
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    UQUIFA

    Registrant Name : Bukwang Pharmaceutical Co., Ltd.

    Registration Date : 2019-02-20

    Registration Number : 20060302-27-B-229-04(9)

    Manufacturer Name : Union quimico farmaceutica, SA

    Manufacturer Address : Poligon Industrial Moli de Planes Font de Bocs S/N C-35, Km. 5708470 Sant Celoni. Bar...

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    Cimetidine

    Spain
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    UQUIFA

    Registrant Name : Sanil Pharma Co., Ltd.

    Registration Date : 2019-12-31

    Registration Number : 20060302-27-B-229-04(12)

    Manufacturer Name : Union quimico farmaceutica, SA

    Manufacturer Address : Poligon Industrial Moli de Planes Font de Bocs S/N C-35, Km. 5708470 Sant Celoni. Bar...

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    ACYCLOVIR

    Spain
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    Spain
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    UQUIFA

    NDC Package Code : 49711-0094

    Start Marketing Date : 2009-10-21

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    ALBENDAZOLE

    Spain
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    Spain
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    UQUIFA

    NDC Package Code : 52286-0001

    Start Marketing Date : 2009-11-03

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    ALBENDAZOLE

    Spain
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    UQUIFA

    NDC Package Code : 52286-5500

    Start Marketing Date : 2009-09-29

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    ALLOPURINOL

    Spain
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    Spain
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    UQUIFA

    NDC Package Code : 49711-0113

    Start Marketing Date : 2009-10-22

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    BICALUTAMIDE

    Spain
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    UQUIFA

    NDC Package Code : 49711-1509

    Start Marketing Date : 2009-10-22

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    BICALUTAMIDE

    Spain
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    UQUIFA

    NDC Package Code : 49711-1504

    Start Marketing Date : 2009-10-22

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    BISMUTH SUBCITRATE POTASSIUM

    Spain
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    Spain
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    UQUIFA

    NDC Package Code : 49711-1521

    Start Marketing Date : 2024-09-05

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    CARISOPRODOL

    Spain
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    Spain
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    UQUIFA

    NDC Package Code : 52286-0021

    Start Marketing Date : 2012-10-26

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    CIMETIDINE

    Spain
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    UQUIFA

    NDC Package Code : 49711-0095

    Start Marketing Date : 2009-10-22

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    CINACALCET HYDROCHLORIDE

    Spain
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    CINACALCET HYDROCHLORIDE

    Spain
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    UQUIFA

    NDC Package Code : 49711-1517

    Start Marketing Date : 2014-11-19

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    UQUIFA is a supplier offers 106 products (APIs, Excipients or Intermediates).

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