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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]
    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

    Impressions: 944

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    https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage

    Radio Compass
    12 Mar 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Top Pharma Companies & Drugs in 2024: Merck’s Keytruda maintains top spot as Novo’s semaglutide nips at its heels

    Top Pharma Companies & Drugs in 2024: Merck’s Keytruda maintains top spot as Novo’s semaglutide nips at its heels

    In 2024, Big Pharma players consolidated and maintained their dominance, even as innovation continued to reshape the pharmaceutical landscape. The primary change last year was the meteoric rise of glucagon-like peptide-1 (GLP-1) receptor agonists that treat diabetes and help in weight loss.Amongst drugmakers, Pfizer retained its numero uno spot with an impressive US$ 63.6 billion in prescription drug sales (up 7 percent from US$ 59.56 billion reported in 2023), despite ever-shrinking Comirnaty sales, which settled at US$ 5.35 billion in 2024 (from US$ 11.22 billion in 2023).Merck secured the second position with revenues of US$ 57.4 billion, a growth of 7 percent over 2023. This performance was predominantly fueled by Keytruda, which now accounts for more than half of Merck’s total pharmaceutical revenue. Johnson & Johnson came a close third with US$ 57 billion in prescription drug sales (up from US$ 54.76 billion in 2023).AbbVie held the fourth position with US$ 56.33 billion in sales, achieving 3.7 percent growth despite the ongoing erosion of Humira revenue. This flagship immunology drug saw sales plummet 37.6 percent to approximately US$ 9 billion, a US$ 5.4 billion reduction compared to 2023. Humira’s loss was offset by AbbVie’s newer immunology assets, particularly Skyrizi and Rinvoq, both of which demonstrated exceptional growth trajectories. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available)European giants Astra, Roche, Novartis, Sanofi round out top 10 list; Novo, Lilly see astounding growthWhile the top four positions were dominated by American drugmakers, European giants dominated the lower half of the top 10 list.AstraZeneca secured the fifth spot with US$ 54.1 billion in sales, thereby posting impressive growth of 18.1 percent over 2023. Roche claimed the sixth position with US$ 50.9 billion in sales while Novartis ranked seventh — with sales of US$ 50.3 billion. Novartis' impressive 10.8 percent sales growth is attributed to its innovative medicines portfolio. Oncology therapies remained a cornerstone for both these Swiss drugmakers.Bristol Myers Squibb (BMS) secured eighth position with revenues of US$ 48.3 billion, representing 7.3 percent growth over the previous year. At US$ 45 billion, Eli Lilly posted 32 percent revenue growth last year. Its GLP-1 drug Mounjaro helped Lilly move up from the tenth in 2023 to the ninth spot last year.Sanofi landed the tenth position with US$ 42.6 billion in sales, propelled largely by the expanding indications of Dupixent. The French multinational has increasingly focused on this immunology blockbuster, while also garnering more sales from its vaccine and rare disease portfolios.Novo Nordisk merits a mention as it posted an incredible 26 percent year-on-year growth. It retained its eleventh spot with US$ 40.25 billion in sales. Novo’s growth was driven almost exclusively by the extraordinary success of its GLP-1 receptor agonist portfolio. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available)       Merck’s Keytruda retains throne with US$ 29.5 bn in sales, as Novo’s semaglutide nips at its heelsMoving on to drugs, Merck’s Keytruda (pembrolizumab) solidified its position as the world’s top-selling pharmaceutical product with sales exceeding US$ 29.5 billion and year-on-year growth of 17.88 percent (US$ 4.5 billion). This remarkable performance was driven by steady sales growth across more than 40 indications in the US. In 2024 alone, Keytruda secured four new approvals from the US Food and Drug Administration (FDA).However, Novo Nordisk’s semaglutide sales (Ozempic, Wegovy and Rybelsus) gave Keytruda a run for its money. Across the three blockbuster drugs, semaglutide earned the Danish drugmaker around US$ 28 billion — i.e. a year-on-year increase of 38 percent.Novo’s Ozempic (semaglutide) reached over US$ 16.7 billion in sales — a 26 percent increase from 2023. Originally approved in 2017 to improve glycemic control, Ozempic bagged additional approvals in 2020, and in January 2025. It is now approved to reduce the risk of major cardiovascular events, as well as to reduce cardiovascular risk and to lower the likelihood of chronic kidney disease in type 2 diabetes patients.Sales of Wegovy (semaglutide), the other blockbuster GLP-1 drug from Novo, grew by a whopping 85.7 percent to over US$ 8 billion.Sanofi and Regeneron’s Dupixent (dupilumab) secured the number three spot with sales of US$ 13.6 billion, representing an impressive 22.4 percent year-on-year growth. In 2024, Dupixent received three new approvals and one label update. Notably, it became the first-ever biologic medicine approved for patients with chronic obstructive pulmonary disease (COPD). View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) AbbVie’s post-Humira strategy pays off as Skyrizi surges 51%; Lilly’s Mounjaro posts 124% growthGilead Sciences’ HIV treatment Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) showed robust growth of 13.27 percent, touching sales of US$ 13.42 billion in 2024 and emerging as the fourth largest selling drug. Biktarvy now commands over 50 percent of the US HIV treatment market. Unlike many other drugs on this list, Biktarvy faces no immediate patent challenges, with key protections expected to remain intact until 2033.BMS and Pfizer’s anticoagulant Eliquis (apixaban) claimed the fifth position with US$ 13.33 billion in sales, representing a 9.21 percent year-on-year increase. AbbVie’s Skyrizi (risankizumab) emerged as one of the fastest-growing assets with a 50.95 percent year-on-year increase, generating US$ 11.71 billion in 2024 sales, thereby surpassing Humira’s (adalimumab) diminished sales.This impressive performance, combined with Rinvoq’s (upadacitinib) growth, has prompted  AbbVie to raise its long-term outlook for these products. The company now expects combined Skyrizi and Rinvoq revenues to exceed US$ 31 billion by 2027, with Skyrizi alone projected to generate over US$ 20 billion.Johnson & Johnson’s Darzalex (daratumumab) claimed the seventh position with US$ 11.67 billion in sales, representing 19.77 percent growth over 2023.Lilly’s Mounjaro (tirzepatide) demonstrated dramatic growth with sales increasing 123.51 percent to US$ 11.54 billion. This performance was complemented by Zepbound (tirzepatide, for weight loss), which contributed US$ 4.9 billion to Lilly’s revenue. By the end of 2024, Mounjaro received FDA approval for a new indication in obstructive sleep apnea (OSA), becoming the first and only prescription medicine for moderate-to-severe OSA in adults with obesity.Stelara (ustekinumab) ranked ninth, bringing J&J sales of US$ 10.36 billion, showing a modest decline of 4.91 percent from its 2023 sales.Vertex’s triple-combination therapy Trikafta (elexacaftor/tezacaftor/ivacaftor) for treating cystic fibrosis rounded out the top ten list with sales of US$ 10.2 billion, up 14 percent from the previous year. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) Our viewIn 2024, transformative therapies like GLP-1 receptor agonists drove growth in the pharmaceutical industry. This year, we expect GLP-1 drugs to dethrone Keytruda from the number one spot. Along with novel immunology agents, we expect GLP-1 drugs to realign the pharmaceutical market.  
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    Impressions: 1611

    https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-drugs-in-2024-merck-s-keytruda-maintains-top-spot-as-novo-s-semaglutide-nips-at-its-heels

    #PharmaFlow by PHARMACOMPASS
    24 Apr 2025
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    NEWS #PharmaBuzz

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    Viatris Files Supplemental Drug Applications in Japan for Effexor
    Viatris Files Supplemental Drug Applications in Japan for Effexor

    21 Apr 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-files-supplemental-new-drug-applications-to-japans-ministry-of-health-labor-and-welfare-for-the-approval-of-effexor-for-the-treatment-of-generalized-anxiety-disorder-302433284.html

    PR NEWSWIRE
    21 Apr 2025
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    Viatris to pay up to $335 M to resolve opioid-related claims
    Viatris to pay up to $335 M to resolve opioid-related claims

    08 Apr 2025

    // REUTERS

    https://www.reuters.com/sustainability/viatris-pay-up-335-million-resolve-opioid-related-claims-2025-04-07/

    REUTERS
    08 Apr 2025
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    Viatris to Report Q1 2025 Financial Results on May 8, 2025
    Viatris to Report Q1 2025 Financial Results on May 8, 2025

    28 Mar 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-to-report-first-quarter-2025-financial-results-on-may-8-2025-302413733.html

    PR NEWSWIRE
    28 Mar 2025
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    Enforcement Report - Week of March 26, 2025
    Enforcement Report - Week of March 26, 2025

    26 Mar 2025

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-26-2025-60230.pdf

    FDA
    26 Mar 2025
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    Mylan Labs is on Health Canada Inspection List
    Mylan Labs is on Health Canada Inspection List

    18 Mar 2025

    // HEALTH CANADA

    https://www.pharmacompass.com/pdf/news/mylan-labs-is-on-health-canada-inspection-list-99723.pdf

    HEALTH CANADA
    18 Mar 2025
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    Viatris to Present at Barclays Global Healthcare Conference
    Viatris to Present at Barclays Global Healthcare Conference

    05 Mar 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-to-present-at-the-barclays-27th-annual-global-healthcare-conference-302393671.html

    PR NEWSWIRE
    05 Mar 2025
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    ALL APIs

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    read-moreClick the button for full data set

    01

    Aciclovir

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

    Cophex
    Not Confirmed
    arrow

    Aciclovir

    U.S.A

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

    arrow
    Cophex
    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 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 : 2025-12-31

    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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    Product
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    Market
    Place

    02

    Febuxostat

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

    Cophex
    Not Confirmed
    arrow

    Febuxostat

    U.S.A

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

    arrow
    Cophex
    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
    blank

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    Web Link

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    #PipelineProspector

    Market
    Place

    03

    Irbesartan

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

    Cophex
    Not Confirmed
    arrow

    Irbesartan

    U.S.A

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

    arrow
    Cophex
    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 : 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
    blank

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    #PipelineProspector

    Market
    Place

    04

    Itraconazole

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

    Cophex
    Not Confirmed
    arrow

    Itraconazole

    U.S.A

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

    arrow
    Cophex
    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 : 2013-02-27

    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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    05

    Lansoprazole

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

    Cophex
    Not Confirmed
    arrow

    Lansoprazole

    U.S.A

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

    arrow
    Cophex
    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 : 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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Rizatriptan Benzoate

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

    Cophex
    Not Confirmed
    arrow

    Rizatriptan Benzoate

    U.S.A

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

    arrow
    Cophex
    Not Confirmed
    • fda
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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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    07

    Rosuvastatin Calcium

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

    Cophex
    Not Confirmed
    arrow

    Rosuvastatin Calcium

    U.S.A

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

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

    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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    08

    Valacyclovir Hydrochloride

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

    Cophex
    Not Confirmed
    arrow

    Valacyclovir Hydrochloride

    U.S.A

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

    arrow
    Cophex
    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 : 65015-745

    Start Marketing Date : 2015-02-17

    End Marketing Date : 2025-12-31

    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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    Market
    Place

    09

    Allopurinol

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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Allopurinol

    U.S.A

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

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

    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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    10

    Lamivudine

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

    Cophex
    Not Confirmed
    arrow

    Lamivudine

    U.S.A

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-28

    Pay. Date : 2013-08-20

    DMF Number : 17750

    Submission : 2004-10-08

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2011-044 - Rev 01

    Issue Date : 2017-10-25

    Type : Chemical

    Substance Number : 2217

    Status : Withdrawn by Holder

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-25

    Written Confirmation Number : WC-0189n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-701

    Start Marketing Date : 2015-01-13

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : GlaxoSmithKline Inc.

    Registration Date : 2020-03-05

    Registration Number : 20200305-209-J-420

    Manufacturer Name : Mylan Laboratories Limited (Unit 2)

    Manufacturer Address : Survey No. 10 & 42, Gaddapotharam(V) Kazipally Industrial Area Jinnaram Mandal Sangareddy District – 502319 Telangana State, India

     VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    (s)-pregabalin

    U.S.A
    MAGHREB PHARMA
    Not Confirmed
    arrow

    02

    Abacavir Sulfate Usp

    U.S.A
    MAGHREB PHARMA
    Not Confirmed
    arrow

    03

    Abaloparatide

    U.S.A
    MAGHREB PHARMA
    Not Confirmed
    arrow

    04

    Abametapir

    U.S.A
    MAGHREB PHARMA
    Not Confirmed
    arrow

    05

    Acyclovir Usp

    U.S.A
    MAGHREB PHARMA
    Not Confirmed
    arrow

    06

    Adefovir Dipivoxil

    U.S.A
    MAGHREB PHARMA
    Not Confirmed
    arrow

    07

    Alendronate Sodium Usp (trihydrate)

    U.S.A
    MAGHREB PHARMA
    Not Confirmed
    arrow

    08

    Allopurinol Usp

    U.S.A
    MAGHREB PHARMA
    Not Confirmed
    arrow

    09

    Almotriptan Malate Usp

    U.S.A
    MAGHREB PHARMA
    Not Confirmed
    arrow

    10

    Alprazolam Usp

    U.S.A
    MAGHREB PHARMA
    Not Confirmed
    arrow
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    FDA Orange Book

    read-more
    read-more

    01

    Brand Name : ABACAVIR SULFATE

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow
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    • EDQM
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    RLD :

    TE Code :

    ABACAVIR SULFATE

    Viatris

    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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    02

    Brand Name : ABACAVIR SULFATE

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow
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    • EDQM
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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
    World Vaccine Conference
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
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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
    Place

    04

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
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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 :

    blank

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    Market
    Place

    05

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
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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
    World Vaccine Conference
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE, LA...

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
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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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    Market
    Place

    07

    Brand Name : EPZICOM

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow

    Brand Name : EPZICOM

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow
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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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    Market
    Place

    08

    Brand Name : ABACAVIR AND LAMIVUD...

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow

    Brand Name : ABACAVIR AND LAMIVUD...

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
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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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    Place

    09

    Brand Name : ABIRATERONE ACETATE

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow

    Brand Name : ABIRATERONE ACETATE

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow
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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
    World Vaccine Conference
    Not Confirmed
    arrow

    Brand Name : ABIRATERONE ACETATE

    U.S.A
    World Vaccine Conference
    Not Confirmed
    arrow
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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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    ABOUT THIS PAGE

    Contact Mylan Laboratories Limited and get a quotation

    Mylan Laboratories Limited is a supplier offers 412 products (APIs, Excipients or Intermediates).

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

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

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