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    Company profile for UQUIFA

    Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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    Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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    xyz-pharma-m-2024-10-07

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    Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

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    Aspen API. More than just an API.

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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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    Spain
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    C/ Mallorca 262, 3rd floor, Barcelona 08008
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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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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

    Radio Compass
    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025. 
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    Impressions: 421

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-bora-polpharma-make-acquisitions-evonik-euroapi-porton-announce-technological-expansions

    #PharmaFlow by PHARMACOMPASS
    19 Dec 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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    Antibody Engineering
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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
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    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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    Market
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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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    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    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
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    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
    Not Confirmed
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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
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    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

    KDMF VMF Others AUDIT
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    04

    Lansoprazole

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

    Antibody Engineering
    Not Confirmed
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    Lansoprazole

    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
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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
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    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
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    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
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    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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    Antibody Engineering
    Not Confirmed
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    USDMF arrow-down
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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
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    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
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    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
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    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
    arrow

    Omeprazole

    Spain

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

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    Antibody Engineering
    Not Confirmed
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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
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    Certificate Number : R0-CEP 2022-120 - Rev 00

    Issue Date : 2022-09-26

    Type : Chemical

    Substance Number : 942

    Status : Valid

     JDMF arrow-down
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    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
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    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
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    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

     VMF Others AUDIT
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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

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

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    Antibody Engineering
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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
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    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
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    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
    • fda
    • EDQM
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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
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    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
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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
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    • 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
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    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

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    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

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    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
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    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
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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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
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    04

    Lansoprazole

    JDMF

    Antibody Engineering
    Not Confirmed
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    Lansoprazole

    Spain
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    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
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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
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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
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    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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    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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    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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    Cimetidine

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    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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    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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    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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    NDC API

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    01

    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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    08

    CARISOPRODOL

    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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    09

    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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    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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    FDA

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-06-18

    UQUIFA

    City : Sant Celoni

    State :

    Country/Area : ES

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-06-18

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    FDA Audited

    USA
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    FDA Audited

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    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-08-04

    UQUIFA

    City : Jiutepec

    State :

    Country/Area : MX

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-08-04

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    FDA Audited

    USA
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    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-09-12

    UQUIFA

    City : Jiutepec

    State :

    Country/Area : MX

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-09-12

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    FDA Audited

    USA
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    FDA Audited

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    Antibody Engineering
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    District Decision : No Action Indicated

    Inspection End Date : 2017-06-01

    UQUIFA

    City : Sant Celoni

    State :

    Country/Area : ES

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-06-01

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    05

    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2015-05-15

    UQUIFA

    City : Sant Celoni

    State :

    Country/Area : ES

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-05-15

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    FDA Audited

    USA
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    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-09-18

    UQUIFA

    City : Llica de Vall

    State :

    Country/Area : ES

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-09-18

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    FDA Audited

    USA
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    FDA Audited

    USA
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    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-07-27

    UQUIFA

    City : Llica de Vall

    State :

    Country/Area : ES

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-07-27

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    08

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
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    FDA Audited

    USA
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    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-07-27

    UQUIFA

    City : Jiutepec

    State :

    Country/Area : MX

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-07-27

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    GMP Certified

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    UQUIFA

    Type : GMP Certificates

    Number : DK API-H 00...

    EudraGMDP Key : 7359

    Country : Mexico

    Issue Date : 2010-07-12

    Post Code : 62578

    NCA Ref : 254764

    City : Civac, Jiutepec, Morelo...

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    GMP Certified

    EU
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    EU
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    Not Confirmed

    UQUIFA

    Type : GMP Certificates

    Number : DK API-V 00...

    EudraGMDP Key : 7360

    Country : Mexico

    Issue Date : 2010-07-12

    Post Code : 62578

    NCA Ref : 254764

    City : Civac, Jiutepec, Morelo...

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    GMP Certified

    EU
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    UQUIFA

    Type : GMP Certificates

    Number : ES/009/ME

    EudraGMDP Key : 23727

    Country : Mexico

    Issue Date : 2014-05-30

    Post Code : MX62578

    NCA Ref : ES/137/14

    City : (Morelos)

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    04

    GMP Certified

    EU
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    Not Confirmed

    UQUIFA

    Type : GMP Certificates

    Number : ES/007/13

    EudraGMDP Key : 16504

    Country : Spain

    Issue Date : 2013-01-10

    Post Code : 08185

    NCA Ref : 36002

    City : Lliçà de Vall

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    GMP Certified

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    UQUIFA

    Type : GMP Certificates

    Number : ES/008/13

    EudraGMDP Key : 16509

    Country : Spain

    Issue Date : 2013-01-10

    Post Code : 08470

    NCA Ref : 36101

    City : Sant Celoni

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    06

    GMP Certified

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    Not Confirmed

    UQUIFA

    Type : GMP Certificates

    Number : NCF-II/1702...

    EudraGMDP Key : 42332

    Country : Spain

    Issue Date : 2017-02-06

    Post Code : 08185

    NCA Ref : 1118-001

    City : LliÇa de Vall

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    GMP Certified

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    UQUIFA

    Type : GMP Certificates

    Number : NCF-II/1827...

    EudraGMDP Key : 49142

    Country : Spain

    Issue Date : 2018-07-13

    Post Code : 08470

    NCA Ref : 1118-002

    City : Sant Celoni

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    08

    GMP Certified

    EU
    Antibody Engineering
    Not Confirmed
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    GMP Certified

    EU
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    Antibody Engineering
    Not Confirmed

    UQUIFA

    Type : GMP Certificates

    Number : NCF-II/1832...

    EudraGMDP Key : 50979

    Country : Spain

    Issue Date : 2018-07-31

    Post Code : 08470

    NCA Ref : 1118-002

    City : Sant Celoni

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    09

    GMP Certified

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    EU
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    Not Confirmed

    UQUIFA

    Type : GMP Certificates

    Number : NCF/17001/0...

    EudraGMDP Key : 42397

    Country : Spain

    Issue Date : 2017-02-06

    Post Code : 08470

    NCA Ref : 1118-002

    City : Sant Celoni

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    10

    GMP Certified

    EU
    Antibody Engineering
    Not Confirmed
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    GMP Certified

    EU
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    Antibody Engineering
    Not Confirmed

    UQUIFA

    Type : GMP Certificates

    Number : NCF-II/1621...

    EudraGMDP Key : 50439

    Country : Spain

    Issue Date : 2016-11-25

    Post Code : 08470

    NCA Ref : 1118-002

    City : Sant Celoni

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