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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]
    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    This week, SpeakPharma interviews four senior executives of LGM Pharma — Shailesh Vengurlekar (Senior VP, Quality and Regulatory Affairs), Deepak Thassu (Senior VP, R&D and Regulatory Submission), Selwyn Lustman (Senior VP, Global Sourcing and Procurement), and Mike Stenberg (VP, Business Development). The four VPs talk about expansion in manufacturing capabilities of the Florida-based contract development and manufacturing organization (CDMO), expertise that makes LGM a strong partner and the criteria it adopts while selecting its suppliers.  HIGHLIGHTS// expansion in manufacturing capabilities/ expertise that makes LGM a strong partner/ criteria for selecting its suppliers LGM Pharma recently invested heavily in expanding its CDMO capabilities by 50 percent. Can you share why offering standalone analytical testing services is important to LGM Pharma’s growth strategy? How does it benefit your clients? Vengurlekar: This recent expansion in CDMO capabilities is part of LGM Pharma’s growth strategy that lays importance on diversification. One key area of this diversification is the offering of standalone Analytical Testing Services (ATS). This service plays a crucial role in supporting our clients by providing them with greater flexibility and reliability. LGM Pharma is already a well-established leader in the API supply chain. We have now identified a significant need in the market and are now serving compounding pharmacies, including 503A and 503B facilities. These pharmacies not only require high-quality, GMP-compliant APIs, but also need a trusted, compliant, and capable laboratory to analyze both their APIs and compounded products. Recognizing this opportunity to further support our clients, LGM Pharma has expanded into ATS. We have witnessed tremendous growth since we’ve launched these services. By offering ATS under a separate legal entity — LGM Pharma Solutions — we are able to provide an additional layer of flexibility to our clients. This structure eliminates any conflict of interest. While LGM Pharma LLC handles API supply, LGM Pharma Solutions focuses on delivering top-tier ATS, all under the same LGM Pharma umbrella. This setup enhances trust and allows our clients to work with us more seamlessly. HIGHLIGHTS// diversified into standalone ATS/ well-established leader in API supply chain/ serving compounding pharmacies/ offering APIs and ATS under different legal entities. While suppositories offer clear advantages for certain medications, can you describe how LGM Pharma plans to leverage its expertise in this area to address specific unmet needs in the growing women’s health market? Thassu: We’re taking a dual approach to enhance both our R&D and manufacturing capabilities. First, we’ve introduced a new semi-automatic machine that allows us to produce smaller batches more efficiently. This is particularly important for the suppository segment, where demand doesn’t require large-scale production. The new system enables quicker adjustments to the manufacturing process, providing us with greater flexibility of producing small batches. Second, many of the materials we handle in the women’s health sector are sensitive to heat, light, and oxygen. To address this, we’re upgrading our facility to accommodate these specialized requirements. This ensures we can develop and manufacture products while maintaining the integrity of heat-, light-, and oxygen-sensitive ingredients. Additionally, we’re working closely with clients to prepare for various technical challenges. Whether it’s processing homeopathic ingredients or handling delicate fermentation-based materials, which are highly sensitive to both light and heat, our team has upgraded its skills and equipment to manage these complexities. From technology advancements in manufacturing to specialized handling conditions and improved technical expertise, we’ve made significant strides to ensure we can meet the evolving needs of our clients and their products. HIGHLIGHTS// dual approach to enhance R&D and manufacturing capabilities/ upgrading facilities to accommodate specialized requirements/ working with clients to address challenges. The pandemic underscored supply chain problems. Can you detail the specific criteria LGM Pharma uses while selecting suppliers for its manufacturing processes? Lustman: LGM looks at many facets of a manufacturer before proceeding to approve them for a specific project. We start by checking their regulatory history with the US Food and Drug Administration (FDA) and other authorities. We try to find out if they have received any warning letters. What is their inspection history? Have they received NAIs (no action indicated) and VAIs (voluntary action indicated)? We further investigate the company’s overall business status — we need to know that they are a stable partner to work with in the long term. Manufacturers are then assessed for their overall technology and the number of employees working in various fields, such as R&D, quality control, quality assurance, regulatory affairs, manufacturing, and the educational levels of these employees. Once we have established that the manufacturer is a potential partner, we check their status for a particular project. We look at their advantages, and whether they have a non-infringing route of synthesis (ROS) that will allow early launch. Are they developing a second process that will be more competitive in pricing? And, does the manufacturer have the necessary capacity and/or spare capacity for the project that we are assessing? We need to know whether the drug master file (DMF) has been registered, the current batch size, and the potential for increase in batch size. Pricing is a key indicator — we need to know whether the pricing of the manufacturer is competitive or not, and if the manufacturer will be able to compete in the future as the project matures. LGM always assesses for quality, price, and delivery. Goods must be of the correct quality, at the right price, with delivery time as desired, in order to meet commercial needs. HIGHLIGHTS// investigate various facets of manufacturer before approving them for a project/ look at advantages, non-infringing ROS/ assess for quality, price, delivery Can you highlight specific capabilities and experiences LGM Pharma possesses that make it a strong partner for companies developing antibody-drug-conjugates (ADCs)? Stenberg: ADCs are often peptides linked with small molecules. However, they may also be peptides linked with oligonucleotides. Regardless, LGM can help manage the supply chain associated with the components that are used in the conjugation of the ADC. LGM has extensive experience, and an extensive network around sourcing and managing the supply chain associated with ADC components. LGM’s experience and capabilities extend to sourcing peptides, small molecules or oligonucleotides used in the conjugation process. Additionally, given our deep relationships in the supply chain aspect of this process, LGM may also be able to identify partners who can help with the conjugation process itself. HIGHLIGHTS// extensive experience, network around sourcing, managing supply chain associated with ADC components / identify partners that can help with conjugation process

    Impressions: 435

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    09 Nov 2024
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    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    This year has seen pivotal advancements in medical innovation. The US Food and Drug Administration (FDA) has approved several groundbreaking therapies that promise to transform patient care across multiple therapeutic areas.Some of the therapies approved have revolutionary delivery mechanisms, while others are first-in-class treatments for previously unaddressed conditions. This week, PharmaCompass brings you a compilation of new pathbreaking approvals of 2024, including advancements in neurology, chronic conditions, mental health conditions, and innovative solutions for various other ailments.Lilly, Alpha Cognition, BMS transform neurological care with new Alzheimer’s, schizophrenia drugsThe neurological treatment landscape saw several major breakthroughs in 2024, particularly in the treatment of Alzheimer’s disease (AD). Eli Lilly’s Kisunla represents a significant advancement in treating early, symptomatic AD. Following decades of failed efforts, Kisunla’s approval, along with that of Eisai-Biogen’s Leqembi last year, marks a turning point in addressing AD.The drug works by targeting and clearing beta amyloid plaque from the brain, thereby attacking the disease’s underlying pathology, rather than just managing symptoms. Administered as an infusion every four weeks, Kisunla’s Medicare coverage makes it accessible to patients in the US who desperately need new treatment options. Alpha Cognition’s Zunveyl emerged as a promising new oral treatment for mild-to-moderate Alzheimer’s-related dementia. Only the second oral AD treatment approved by the FDA in over a decade, Zunveyl is a prodrug, or a biologically inactive compound that can be metabolized by the body to produce a drug. It remains inactive as it passes through the stomach and enhances cholinergic function in the brain.Perhaps one of the most exciting breakthroughs of 2024 was Bristol-Myers Squibb’s Cobenfy. This revolutionary antipsychotic medication for schizophrenia represents the first novel approach to treatment since the 1950s. Unlike traditional antipsychotics that target dopamine receptors, Cobenfy works through cholinergic receptors, offering new hope to patients who struggle with the side effects of conventional treatments.Traditional antipsychotics have been associated with several mild and serious side effects such as weight gain, feeling unmotivated and sluggish, high rates of cardiac disease, and even early death. Cobenfy’s innovative mechanism of action has generated excitement in the medical community. Experts project Cobenfy to bring in US$ 7.5 billion in peak annual sales, thereby validating BMS’ recent, US$ 14-billion acquisition of Karuna Therapeutics.Verona, Sanofi’s drugs revolutionize COPD care; Madrigal’s Rezdiffra offers hope to MASH patients The landscape of chronic obstructive pulmonary disease (COPD) treatment saw remarkable advances in 2024. Verona Pharma’s Ohtuvayre brings the first new mechanism of action in over two decades for COPD treatment. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management.Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Dupixent is Sanofi’s best-selling drug. It is poised to cross over € 21 billion (US$ 23.5 billion) in sales by 2030, with COPD likely to contribute US$ 2.9 billion, predict analysts. Over 390 million people are living with COPD worldwide.In the field of liver disease, Madrigal Pharmaceuticals’ Rezdiffra became the first FDA-approved treatment for metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring. This approval represents a breakthrough in a field that has been notorious for being a graveyard for failed programs. Rezdiffra offers hope to patients with this common liver condition, which primarily affects those with obesity or type 2 diabetes. The American Liver Foundation has termed this approval a “game-changing” moment in hepatology.For the rare disease community, Ipsen’s Iqirvo emerged as the first new medicine approved in nearly a decade for primary biliary cholangitis (PBC). This first-in-class peroxisome proliferator-activated receptor (PPAR) agonist offers new hope for the approximately 100,000 Americans affected by this condition, particularly women aged 30 to 60 years.A significant breakthrough for patients with hypoparathyroidism came with the approval of Ascendis’ Yorvipath, making it the only treatment for hypoparathyroidism in adults. By directly addressing the underlying hormone deficiency, Yorvipath helps stabilize calcium levels in the blood, reducing the treatment burden associated with managing symptoms through calcium and vitamin D supplements alone.In the realm of pulmonary medicine, Merck’s Winrevair emerged as the first new therapy for pulmonary arterial hypertension (PAH) in over a decade. As the first approved activin-signaling inhibitor therapy, Winrevair represents a novel approach to treating this rare but severe condition that doctors call a “ticking time bomb”. The drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to death within a decade of diagnosis.ARS Pharma launches nasal spray alternative to EpiPen, Eicos introduces med for severe frostbiteLeading the charge in innovative drug delivery is ARS Pharma’s Neffy, the first-ever nasal spray alternative to the EpiPen for treating severe allergic reactions. This groundbreaking advancement represents the first major innovation in anaphylaxis treatment in over a decade. For children and individuals with needle phobia, this nasal spray format addresses one of the most significant barriers to timely treatment of allergic emergencies. Speaking of emergency medicine, Eicos Sciences’ Aurlumyn made history as the first FDA-approved treatment for severe frostbite. This approval fills a critical gap in emergency care, offering a medical intervention that could prevent the need for amputation in severe cases.The cardiovascular space saw its first oral anti-hypertensive therapy that works through a new therapeutic pathway in almost 40 years. Idorsia’s Tryvio is a treatment for hypertension that offers new hope to patients whose blood pressure remains inadequately controlled on existing medications. Idorsia expects millions of patients to benefit from it.Our view This year, the pharmaceutical industry has taken a remarkable leap forward by addressing some of healthcare’s most challenging conditions. Treatments like BMS’ Cobenfy for schizophrenia and Madrigal’s Rezdiffra for MASH demonstrate the industry’s growing ability to translate science into practical therapies. With the growing use of artificial intelligence in the drug industry, we hope that these approvals are just a precursor to a bevy of pathbreaking therapies in the years to come. 
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    Impressions: 491

    https://www.pharmacompass.com/radio-compass-blog/medical-breakthroughs-in-2024-alzheimer-s-schizophrenia-copd-mash-see-pathbreaking-treatments

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    14 Nov 2024
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    NEWS #PharmaBuzz

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    Viatris Reports Q3 Financial Results for 2024
    Viatris Reports Q3 Financial Results for 2024

    07 Nov 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-reports-third-quarter-financial-results-for-2024-302298689.html

    PR NEWSWIRE
    07 Nov 2024
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    Viatris Announces Q32024 Dividend
    Viatris Announces Q32024 Dividend

    05 Nov 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-announces-third-quarter-2024-dividend-302296180.html

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    05 Nov 2024
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    Viatris Named to Forbes' World's Top Companies for Women 2024 List
    Viatris Named to Forbes' World's Top Companies for Women 2024 List

    29 Oct 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-named-to-forbes-worlds-top-companies-for-women-2024-list-302290273.html

    PR NEWSWIRE
    29 Oct 2024
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    Viatris To Participate In UBS And Jefferies Healthcare Conferences
    Viatris To Participate In UBS And Jefferies Healthcare Conferences

    29 Oct 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-to-participate-in-the-ubs-global-healthcare-conference-and-jefferies-london-healthcare-conference-302290043.html

    PR NEWSWIRE
    29 Oct 2024
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    Lexicon Announces Licensing Agreement With Viatris For Sotagliflozin
    Lexicon Announces Licensing Agreement With Viatris For Sotagliflozin

    16 Oct 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/10/16/2964507/0/en/Lexicon-Announces-Exclusive-Licensing-Agreement-With-Viatris-for-Sotagliflozin-in-All-Markets-Outside-of-the-U-S-and-Europe.html

    GLOBENEWSWIRE
    16 Oct 2024
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    Viatris Announces Licenses Sotagliflozin Outside U.S. And Europe
    Viatris Announces Licenses Sotagliflozin Outside U.S. And Europe

    16 Oct 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-announces-exclusive-licensing-agreement-with-lexicon-pharmaceuticals-for-sotagliflozin-in-all-markets-outside-of-the-us-and-europe-302278473.html

    PR NEWSWIRE
    16 Oct 2024
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    ALL APIs

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    01

    Aciclovir

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

    Compamed
    Not Confirmed
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    Aciclovir

    U.S.A

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

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    Compamed
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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 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

    Compamed
    Not Confirmed
    arrow

    Febuxostat

    U.S.A

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

    arrow
    Compamed
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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

    KDMF VMF Others AUDIT
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    03

    Irbesartan

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

    Compamed
    Not Confirmed
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    Irbesartan

    U.S.A

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

    arrow
    Compamed
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    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

    Compamed
    Not Confirmed
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    Itraconazole

    U.S.A

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

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    Compamed
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    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

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    05

    Lansoprazole

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

    Compamed
    Not Confirmed
    arrow

    Lansoprazole

    U.S.A

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

    arrow
    Compamed
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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

    Compamed
    Not Confirmed
    arrow

    Rivaroxaban

    U.S.A

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

    arrow
    Compamed
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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

    Compamed
    Not Confirmed
    arrow

    Rizatriptan Benzoate

    U.S.A

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

    arrow
    Compamed
    Not Confirmed
    • fda
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    ✖

    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

    Compamed
    Not Confirmed
    arrow

    Rosuvastatin Calcium

    U.S.A

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

    arrow
    Compamed
    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

    Compamed
    Not Confirmed
    arrow

    Valacyclovir Hydrochloride

    U.S.A

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

    arrow
    Compamed
    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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    10

    Allopurinol

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

    Compamed
    Not Confirmed
    arrow

    Allopurinol

    U.S.A

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

    arrow
    Compamed
    Not Confirmed
    • fda
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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
    read-more

    01

    (s)-pregabalin

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    02

    Abacavir Sulfate Usp

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Abacavir Sulfate Usp

    U.S.A
    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
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    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
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    03

    Abaloparatide

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    04

    Abametapir

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    05

    Acyclovir Usp

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Acyclovir Usp

    U.S.A
    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
    • EDQM
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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
    The Pharmacy Technology
    Not Confirmed
    arrow

    07

    Alendronate Sodium Usp (trihydrate)

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    08

    Allopurinol Usp

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    09

    Almotriptan Malate Usp

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Almotriptan Malate Usp

    U.S.A
    arrow
    The Pharmacy Technology
    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
    The Pharmacy Technology
    Not Confirmed
    arrow
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    CEP/COS

    read-more
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    01

    Amlodipine besilate

    CEP/COS

    The Pharmacy Technology
    Not Confirmed
    arrow

    02

    Amlodipine besilate, Process C

    CEP/COS

    The Pharmacy Technology
    Not Confirmed
    arrow

    03

    Atenolol

    CEP/COS

    The Pharmacy Technology
    Not Confirmed
    arrow

    Atenolol

    U.S.A
    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
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    • WHO-GMP
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    Viatris

    Certificate Numbers : R0-CEP 2007-306 - Rev 02

    Status : Withdrawn by Holder

    Issue Date : 2011-11-08

    Type : Chemical

    Substance Number : 703

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    Market
    Place

    04

    Azathioprine

    CEP/COS

    The Pharmacy Technology
    Not Confirmed
    arrow

    Azathioprine

    U.S.A
    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
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    Viatris

    Certificate Numbers : R0-CEP 2017-008 - Rev 01

    Status : Withdrawn by Holder

    Issue Date : 2019-12-18

    Type : Chemical

    Substance Number : 369

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    Market
    Place

    05

    Capecitabine

    CEP/COS

    The Pharmacy Technology
    Not Confirmed
    arrow

    Capecitabine

    U.S.A
    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
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    Viatris

    Certificate Numbers : R0-CEP 2013-359 - Rev 01

    Status : Withdrawn by Holder

    Issue Date : 2017-09-27

    Type : Chemical

    Substance Number : 2762

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    Market
    Place

    06

    Ciprofloxacin

    CEP/COS

    The Pharmacy Technology
    Not Confirmed
    arrow

    Ciprofloxacin

    U.S.A
    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
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    Viatris

    Certificate Numbers : R1-CEP 2010-001 - Rev 03

    Status : Withdrawn by Holder

    Issue Date : 2019-08-13

    Type : Chemical

    Substance Number : 1089

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    Market
    Place

    07

    Ciprofloxacin Hydrochloride

    CEP/COS

    The Pharmacy Technology
    Not Confirmed
    arrow

    08

    Clopidogrel hydrogen sulfate

    CEP/COS

    The Pharmacy Technology
    Not Confirmed
    arrow

    09

    Dacarbazine

    CEP/COS

    The Pharmacy Technology
    Not Confirmed
    arrow

    Dacarbazine

    U.S.A
    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
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    Viatris

    Certificate Numbers : R0-CEP 2016-082 - Rev 01

    Status : Withdrawn by Holder

    Issue Date : 2019-12-18

    Type : Chemical

    Substance Number : 1691

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    Market
    Place

    10

    Desmopressin

    CEP/COS

    The Pharmacy Technology
    Not Confirmed
    arrow

    Desmopressin

    U.S.A
    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
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    • WHO-GMP
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    Viatris

    Certificate Numbers : R0-CEP 2012-176 - Rev 02

    Status : Withdrawn by Holder

    Issue Date : 2017-09-18

    Type : Chemical

    Substance Number : 712

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    NDC API

    read-more
    read-more

    01

    ABACAVIR SULFATE

    U.S.A
    Compamed
    Not Confirmed
    arrow

    ABACAVIR SULFATE

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    NDC Package Code : 65015-640

    Start Marketing Date : 2015-02-13

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
    Place

    02

    ACYCLOVIR

    U.S.A
    Compamed
    Not Confirmed
    arrow

    ACYCLOVIR

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Viatris

    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

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    Market
    Place

    03

    ALENDRONATE SODIUM

    U.S.A
    Compamed
    Not Confirmed
    arrow

    ALENDRONATE SODIUM

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Viatris

    NDC Package Code : 65015-683

    Start Marketing Date : 2015-02-13

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
    Place

    04

    ALLOPURINOL

    U.S.A
    Compamed
    Not Confirmed
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    ALLOPURINOL

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Viatris

    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

    blank

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    Market
    Place

    05

    ALMOTRIPTAN MALATE

    U.S.A
    Compamed
    Not Confirmed
    arrow

    ALMOTRIPTAN MALATE

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Viatris

    NDC Package Code : 65015-673

    Start Marketing Date : 2015-01-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    06

    ALPRAZOLAM

    U.S.A
    Compamed
    Not Confirmed
    arrow

    ALPRAZOLAM

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Viatris

    NDC Package Code : 65015-634

    Start Marketing Date : 2015-01-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    07

    AMBRISENTAN

    U.S.A
    Compamed
    Not Confirmed
    arrow

    AMBRISENTAN

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Viatris

    NDC Package Code : 65015-793

    Start Marketing Date : 2015-02-12

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    08

    AMLODIPINE BESYLATE

    U.S.A
    Compamed
    Not Confirmed
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    AMLODIPINE BESYLATE

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Viatris

    NDC Package Code : 65015-670

    Start Marketing Date : 2015-01-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    AMLODIPINE BESYLATE

    U.S.A
    Compamed
    Not Confirmed
    arrow

    AMLODIPINE BESYLATE

    U.S.A
    arrow
    Compamed
    Not Confirmed
    • fda
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    Viatris

    NDC Package Code : 65427-003

    Start Marketing Date : 2014-07-03

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    10

    APIXABAN

    U.S.A
    Compamed
    Not Confirmed
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    APIXABAN

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Viatris

    NDC Package Code : 65015-897

    Start Marketing Date : 2020-08-12

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    LISTED APIs

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    5-Fluorocytosine

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    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 oper...
    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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    01

    5-Fluorocytosine

    U.S.A
    Compamed
    Not Confirmed
    arrow

    5-Fluorocytosine

    U.S.A
    arrow
    Compamed
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Viatris

    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.

    About the Company : 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) i...

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    Abacavir Sulfate

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    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 oper...
    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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    02

    Abacavir Sulfate

    U.S.A
    Compamed
    Not Confirmed
    arrow

    Abacavir Sulfate

    U.S.A
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    Viatris

    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.

    About the Company : 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) i...

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    Abaloparatide

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    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 oper...
    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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    03

    Abaloparatide

    U.S.A
    Compamed
    Not Confirmed
    arrow

    Abaloparatide

    U.S.A
    arrow
    Compamed
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    Viatris

    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.

    About the Company : 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) i...

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    Abametapir

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    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 oper...
    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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    04

    Abametapir

    U.S.A
    Compamed
    Not Confirmed
    arrow

    Abametapir

    U.S.A
    arrow
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    Viatris

    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.

    About the Company : 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) i...

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    Abemaciclib

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    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 oper...
    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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    05

    Abemaciclib

    U.S.A
    Compamed
    Not Confirmed
    arrow

    Abemaciclib

    U.S.A
    arrow
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    Viatris

    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.

    About the Company : 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) i...

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    Acyclovir

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    Market
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    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 oper...
    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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    06

    Acyclovir

    U.S.A
    Compamed
    Not Confirmed
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    Acyclovir

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Viatris

    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.

    About the Company : 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) i...

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    Adenine

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    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 oper...
    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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    07

    Adenine

    U.S.A
    Compamed
    Not Confirmed
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    Adenine

    U.S.A
    arrow
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    Not Confirmed
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    Viatris

    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.

    About the Company : 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) i...

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    Adrenaline

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    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 oper...
    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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    08

    Adrenaline

    U.S.A
    Compamed
    Not Confirmed
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    Adrenaline

    U.S.A
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    Not Confirmed
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    Viatris

    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.

    About the Company : 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) i...

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    Alprazolam

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    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 oper...
    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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    09

    Alprazolam

    U.S.A
    Compamed
    Not Confirmed
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    Alprazolam

    U.S.A
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    Not Confirmed
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    Viatris

    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.

    About the Company : 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) i...

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    Ambrisentan

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    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 oper...
    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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    10

    Ambrisentan

    U.S.A
    Compamed
    Not Confirmed
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    Ambrisentan

    U.S.A
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    Viatris

    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.

    About the Company : 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) i...

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    FDA Orange Book

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    01

    Brand Name : ABACAVIR SULFATE

    China
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    China
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR SULFATE

    MATRIX LABORATORIES XIAMEN LTD.

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : 300MG

    Approval Date :

    Application Number : 78742

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Market
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    02

    Brand Name : ABACAVIR SULFATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD : No

    TE Code : AB

    ABACAVIR SULFATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : EQ 300MG BASE

    Approval Date : 2012-06-18

    Application Number : 91294

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    Brand Name : ABACAVIR SULFATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR SULFATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : 60 MG

    Approval Date :

    Application Number : 200733

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Market
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    04

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE; LAMIVU...

    Dosage Strength : 600MG; 300MG

    Approval Date :

    Application Number : 90519

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Market
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    05

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE; LAMIVU...

    Dosage Strength : 60MG; 30MG

    Approval Date :

    Application Number : 202381

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    06

    Brand Name : ABACAVIR SULFATE, LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE, LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE, LAMIVU...

    Dosage Strength : EQ 300MG BASE; 150MG; 30...

    Approval Date :

    Application Number : 90309

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    07

    Brand Name : EPZICOM

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : EPZICOM

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : EPZICOM

    Dosage Strength : 600MG;300MG

    Approval Date :

    Application Number : 204004

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    08

    Brand Name : ABACAVIR AND LAMIVUD...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : ABACAVIR AND LAMIVUD...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL SUSPENSION

    Proprietary Name : ABACAVIR AND LAMIVUDINE

    Dosage Strength : 120MG;60MG

    Approval Date :

    Application Number : 204915

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Market
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    09

    Brand Name : ABIRATERONE ACETATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : ABIRATERONE ACETATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 250MG

    Approval Date : 2018-10-31

    Application Number : 208446

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    Brand Name : ABIRATERONE ACETATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : ABIRATERONE ACETATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 500MG

    Approval Date : 2020-12-14

    Application Number : 208446

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Market
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    Only 10 entries up to this point, click to access all click full view read-more
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    Europe

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    01

    Brand Name : Idarubicin

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Idarubicin

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    4-Demethoxydaunomycin

    Viatris

    Dosage Form : Idarubicin 10Mg 10Ml 1 Units P...

    Dosage Strength : 1 vial EV 10 mg/10 ml

    Packaging :

    Brand Name : Idarubicin

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    Brand Name : Abirateron Viatris

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Abirateron Viatris

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Abirateroni acetas

    Viatris

    Dosage Form : Filmtabl

    Dosage Strength : 1000mg

    Packaging :

    Brand Name : Abirateron Viatris

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    03

    Brand Name : Abirateron Viatris

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Abirateron Viatris

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Abirateroni acetas

    Viatris

    Dosage Form : Filmtabl

    Dosage Strength : 500mg

    Packaging :

    Brand Name : Abirateron Viatris

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Market
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    04

    Brand Name : Mucomyst

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Inhalation liquid for nebulize...

    Dosage Strength : 200 mg/ml

    Packaging : Vials 10 10ml

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    05

    Brand Name : Mucomyst

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Inhalation liquid for nebulize...

    Dosage Strength : 200 mg/ml

    Packaging : Vials 1 10ml

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    06

    Brand Name : Mucomyst

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Compamed
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Effervescent tablet

    Dosage Strength : 200 mg

    Packaging : Plastic pipe 25...

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Market
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    07

    Brand Name : Mucomyst

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Compamed
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Effervescent tablet

    Dosage Strength : 200 mg

    Packaging : Plastic pipe 4 2...

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Market
    Place

    08

    Brand Name : Mucomyst

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Inhalation liquid for nebulize...

    Dosage Strength : 200 mg/ml

    Packaging : Vials 5 10ml

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Market
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    09

    Brand Name : ACETYLSALICYLIC ACID...

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : ACETYLSALICYLIC ACID...

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Acetylsalicylic acid

    Viatris

    Dosage Form : Gastro-Resistant Tablets

    Dosage Strength : 100 mg

    Packaging : 30 UNITS 100 MG - ...

    Brand Name : ACETYLSALICYLIC ACID MYLAN

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Market
    Place

    10

    Brand Name : Cyclokapron

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Cyclokapron

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum tranexamicum

    Viatris

    Dosage Form : Tabl

    Dosage Strength : 500mg

    Packaging :

    Brand Name : Cyclokapron

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Market
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    Only 10 entries up to this point, click to access all click full view read-more
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    Excipients

    Click here to find the perfect excipient manufacturers by their capabilities

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    01

    Mannitol

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

    Compamed
    Not Confirmed
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    Mannitol

    U.S.A

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

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    Compamed
    Not Confirmed
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38630

    Submission : 2023-08-21

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Salcaprozate Sodium Excipient

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

    Compamed
    Not Confirmed
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    Salcaprozate Sodium Excipient

    U.S.A

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

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    Compamed
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37682

    Submission : 2022-12-02

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    POLYOLPREPOLYMER -02

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

    Compamed
    Not Confirmed
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    POLYOLPREPOLYMER -02

    U.S.A

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

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    Compamed
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22569

    Submission : 2009-02-23

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    TRIETHYLAMMONIUM SUCROSE OCTASULFAT...

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

    Compamed
    Not Confirmed
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    TRIETHYLAMMONIUM SUCROSE OCTASULFAT...

    U.S.A

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

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    Compamed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37813

    Submission : 2023-03-28

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    BERTEK CODE 44119 MEDILAM 3600

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

    Compamed
    Not Confirmed
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    BERTEK CODE 44119 MEDILAM 3600

    U.S.A

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

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    Compamed
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11884

    Submission : 1996-03-04

    Status : Inactive

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    PIB ADHESIVE

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

    Compamed
    Not Confirmed
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    PIB ADHESIVE

    U.S.A

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

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    Compamed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14785

    Submission : 2000-03-16

    Status : Inactive

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    ABOUT THIS PAGE

    Contact Mylan Laboratories Limited and get a quotation

    Mylan Laboratories Limited is a supplier offers 391 products (APIs, Excipients or Intermediates).

    Find a price of Aciclovir bulk with DMF, JDMF, WC offered by Mylan Laboratories Limited

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