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    About

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to co...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

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    Robert J. Coury Global Center 1000 Mylan Blvd. Canonsburg, PA 15317
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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: 460

    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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    Viatris Publishes Phase 2b CARE Study Data for Cenerimod
    Viatris Publishes Phase 2b CARE Study Data for Cenerimod

    18 Dec 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-announces-publication-of-phase-2b-care-study-data-for-cenerimod-in-lancet-rheumatology-302334364.html

    PR NEWSWIRE
    18 Dec 2024
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    Enforcement Report - Week of December 18, 2024
    Enforcement Report - Week of December 18, 2024

    18 Dec 2024

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-18-2024-87175.pdf

    FDA
    18 Dec 2024
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    Mylan`s Generics Glucagon Receives Approval in US
    Mylan`s Generics Glucagon Receives Approval in US

    12 Dec 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204468

    FDA
    12 Dec 2024
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    Mylan Pharma`s Biologic Semglee Receives Suppl Approval in US
    Mylan Pharma`s Biologic Semglee Receives Suppl Approval in US

    25 Nov 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761201

    FDA
    25 Nov 2024
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    UK Watchdog Fines Viatris $1.9M Over Rule Breach In Theramex Probe
    UK Watchdog Fines Viatris $1.9M Over Rule Breach In Theramex Probe

    22 Nov 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/uk-watchdog-fines-viatris-19-mln-over-rule-breach-theramex-probe-2024-11-22/

    REUTERS
    22 Nov 2024
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    Viatris fined in Morocco over merger notification, sources say
    Viatris fined in Morocco over merger notification, sources say

    21 Nov 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/vitaris-fined-morocco-over-merger-notification-sources-say-2024-11-21/

    REUTERS
    21 Nov 2024
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    ALL APIs

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    01

    Aciclovir

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Aciclovir

    U.S.A

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

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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-19

    DMF Number : 13277

    Submission : 1998-10-22

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10974

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2006-12-01

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-600

    Start Marketing Date : 2015-01-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Bukwang Pharmaceutical Co., Ltd.

    Registration Date : 2018-05-04

    Registration Number : 20050831-33-A-83-09(3)

    Manufacturer Name : Mylan Laboratories Limited

    Manufacturer Address : 14, 99 & 100, Industrial Development Area Pashamylaram, Phase-II, Patancheru, 502 307, Medak District, Telangana, India

     VMF Others AUDIT
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    02

    Febuxostat

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Febuxostat

    U.S.A

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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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 : 2013-03-22

    Pay. Date : 2013-01-07

    DMF Number : 26657

    Submission : 2013-01-15

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 230MF10138

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2018-10-01

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-820

    Start Marketing Date : 2015-08-20

    End Marketing Date : 2026-12-01

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

    Marketing Category : BULK INGREDIENT

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    03

    Irbesartan

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Irbesartan

    U.S.A

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

    arrow
    Pharma, Lab & Chemical Expo
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17912

    Submission : 2004-12-20

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF10138

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2016-07-27

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    04

    Itraconazole

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

    Pharma, Lab & Chemical Expo
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    Itraconazole

    U.S.A

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

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    Pharma, Lab & Chemical Expo
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-27

    Pay. Date : 2013-02-06

    DMF Number : 17739

    Submission : 2004-10-08

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 219MF10105

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2007-03-23

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-624

    Start Marketing Date : 2015-01-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Lansoprazole

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Lansoprazole

    U.S.A

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-11-16

    Pay. Date : 2015-11-06

    DMF Number : 19555

    Submission : 2006-06-27

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 227MF10198

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2015-08-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-658

    Start Marketing Date : 2015-01-29

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Rivaroxaban

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Rivaroxaban

    U.S.A

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

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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-04-21

    Pay. Date : 2020-03-31

    DMF Number : 34226

    Submission : 2019-10-15

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 302MF10144

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills,Hyderabad-500096,Telangana,India

    Initial Date of Registration : 2020-12-07

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-898

    Start Marketing Date : 2020-10-27

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    07

    Rizatriptan Benzoate

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Rizatriptan Benzoate

    U.S.A

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-09-11

    Pay. Date : 2015-09-03

    DMF Number : 19098

    Submission : 2006-01-10

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 227MF10282

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2015-12-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-653

    Start Marketing Date : 2015-01-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    08

    Rosuvastatin Calcium

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Rosuvastatin Calcium

    U.S.A

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-02-07

    Pay. Date : 2014-02-04

    DMF Number : 23766

    Submission : 2010-04-27

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF10114

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2016-06-17

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-752

    Start Marketing Date : 2015-01-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    09

    Valacyclovir Hydrochloride

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Valacyclovir Hydrochloride

    U.S.A

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-08-13

    Pay. Date : 2019-08-09

    DMF Number : 17943

    Submission : 2004-12-29

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 224MF10156

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2012-08-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-629

    Start Marketing Date : 2015-01-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharma Science Korea Co., Ltd.

    Registration Date : 2022-10-31

    Registration Number : 20221031-209-J-1353

    Manufacturer Name : Mylan Laboratories Limited (Unit-7)

    Manufacturer Address : Plot No. 14, 99 & 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District 502307, Telangana State, India

     VMF Others AUDIT
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    Place

    10

    Allopurinol

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Allopurinol

    U.S.A

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16409

    Submission : 2003-04-23

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10578

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2005-09-14

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-06-03

    Valid Till : 2022-06-02

    Written Confirmation Number : WC-0015

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-606

    Start Marketing Date : 2015-02-12

    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
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    01

    (s)-pregabalin

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    02

    Abacavir Sulfate Usp

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Abacavir Sulfate Usp

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-06-16

    Pay. Date : 2017-05-11

    DMF Number : 18229

    Submission : 2005-03-30

    Status : Active

    Type : II

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    Market
    Place

    03

    Abaloparatide

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    04

    Abametapir

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    05

    Acyclovir Usp

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Acyclovir Usp

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-19

    DMF Number : 13277

    Submission : 1998-10-22

    Status : Active

    Type : II

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    Market
    Place

    06

    Adefovir Dipivoxil

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    07

    Alendronate Sodium Usp (trihydrate)

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    08

    Allopurinol Usp

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    09

    Almotriptan Malate Usp

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Almotriptan Malate Usp

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-02-08

    Pay. Date : 2012-11-06

    DMF Number : 20424

    Submission : 2007-03-22

    Status : Active

    Type : II

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    Market
    Place

    10

    Alprazolam Usp

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow
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    EU WC

    read-more
    read-more

    01

    Abacavir Sulfate USP/EP

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    02

    Abacavir Sulphate EP

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    03

    Abacavir Sulphate USP

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    04

    Aciclovir (Ph. Eur.)/USP

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    05

    Adefovir Dipivoxil (INH)

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    06

    Alendronate Sodium USP/Ph. E...

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    07

    Allopurinol USP/EP

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    08

    Almotriptan maleate IH

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    09

    Almotriptan Malate IH

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    10

    Alprazolam (Ph. Eur.)

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow
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    KDMF

    read-more
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    01

    Acyclovir

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Acyclovir

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    Registrant Name : Handok Co., Ltd.

    Registration Date : 2012-03-23

    Registration Number : 20050831-33-A-83-09(1)

    Manufacturer Name : Mylan Laboratories Limited (Un...

    Manufacturer Address : Plot No. 14, 99 & 100, IDA Pashamylaram Phase-II Patancheru, Sangareddy District-5023...

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    Market
    Place

    02

    Acyclovir

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Acyclovir

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    Registrant Name : Bukwang Pharmaceutical Co., Ltd.

    Registration Date : 2018-05-04

    Registration Number : 20050831-33-A-83-09(3)

    Manufacturer Name : Mylan Laboratories Limited

    Manufacturer Address : 14, 99 & 100, Industrial Development Area Pashamylaram, Phase-II, Patancheru, 502 307...

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    Market
    Place

    03

    Acyclovir

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Acyclovir

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    Registrant Name : GlaxoSmithKline Inc.

    Registration Date : 2005-08-31

    Registration Number : 20050831-33-A-83-09

    Manufacturer Name : Mylan Laboratories Limited (Un...

    Manufacturer Address : Plot No. 14, 99 & 100, IDA Pashamylaram Phase-II Patancheru, Sangareddy District-5023...

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    Market
    Place

    04

    Amlodipine besilate

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Amlodipine besilate

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2017-02-22

    Registration Number : 20120911-130-H-215-39(2)

    Manufacturer Name : Mylan Laboratories Limited

    Manufacturer Address : Unit-7, Plot No. 14, 99 & 100, IDA, Pashamylaram, Phase-II, Patancheru, Sangareddy Di...

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    Market
    Place

    05

    Amlodipine besilate

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Amlodipine besilate

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    Registrant Name : Docheo Co., Ltd.

    Registration Date : 2012-12-28

    Registration Number : 20120911-130-H-215-39(1)

    Manufacturer Name : Mylan Laboratories Limited (Un...

    Manufacturer Address : Unit-7, Plot No. 14, 99 & 100, IDA, Pashamylaram, Phase-II, Patancheru, Sangareddy Di...

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    Market
    Place

    06

    Atorvastatin calcium

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Atorvastatin calcium

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2012-05-25

    Registration Number : 20120525-132-H-208-17

    Manufacturer Name : Tianish Laboratories Private L...

    Manufacturer Address : (Unit-8) G. Chodavaram, Poosapatirega Mandal Vizianagaram District - 535204 Andhra Pr...

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    Market
    Place

    07

    Atorvastatin calcium

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Atorvastatin calcium

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2019-04-11

    Registration Number : 20120525-132-H-208-17(2)

    Manufacturer Name : Mylan Laboratories Limited

    Manufacturer Address : Unit-8, G.Chodavaram, Poosapatirega Mandal Vizianagaram District, Telangana, India

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    Market
    Place

    08

    Atorvastatin calcium

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Atorvastatin calcium

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    • WHO-GMP
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    Viatris

    Registrant Name : Celltrion Pharmaceutical Co., Ltd.

    Registration Date : 2015-12-11

    Registration Number : 20120525-132-H-208-17(1)

    Manufacturer Name : Mylan Laboratories Limited (Un...

    Manufacturer Address : Unit-8, G.Chodavaram, Poosapatirega Mandal Vizianagaram District, Telangana, India

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    Market
    Place

    09

    Atorvastatin calcium

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Atorvastatin calcium

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    • WHO-GMP
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    Viatris

    Registrant Name : Toru Corporation

    Registration Date : 2019-12-19

    Registration Number : 20120525-132-H-208-17(3)

    Manufacturer Name : MYLAN LABORATORIES LIMITED

    Manufacturer Address : (Unit-8) G. Chodavaram, Poosapatirega Mandal Vizianagaram District - 535204 Andhra Pr...

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    10

    Deferasirox

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Deferasirox

    U.S.A
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    • WHO-GMP
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    Viatris

    Registrant Name : Geonil Pharmaceutical Co., Ltd.

    Registration Date : 2017-12-26

    Registration Number : No. 2816-1-ND(1)

    Manufacturer Name : Mylan Laboratories Limited

    Manufacturer Address : Unit-8, G.Chodavaram, Pusapatirega Mandal, Vizianagaram District-535204, Andhra Prade...

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    Excipients

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    Inspections and registrations

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    FDA

    read-more
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    01

    FDA Audited

    USA
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-04-16

    Viatris

    City : Greensboro

    State : NC

    Country/Area : US

    Zip : 27406-4600

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-04-16

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    02

    FDA Audited

    USA
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-07-30

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-07-30

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    #PharmaFlow

    03

    FDA Audited

    USA
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-02-17

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-02-17

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    04

    FDA Audited

    USA
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    FDA Audited

    USA
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2010-12-09

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2010-12-09

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    FDA Audited

    USA
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-28

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Postmarket Surv. and Epidemiolog...

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-28

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    FDA Audited

    USA
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-02-02

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-02-02

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    07

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    FDA Audited

    USA
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-03-21

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-03-21

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    08

    FDA Audited

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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    FDA Audited

    USA
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-04-24

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-04-24

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    09

    FDA Audited

    USA
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    FDA Audited

    USA
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-13

    Viatris

    City : Rockford

    State : IL

    Country/Area : US

    Zip : 61103-1201

    District : CHI

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-13

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    10

    FDA Audited

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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    FDA Audited

    USA
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-13

    Viatris

    City : Rockford

    State : IL

    Country/Area : US

    Zip : 61103-1287

    District : CHI

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-13

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