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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.

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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 

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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

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    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 20 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 17.2 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: 2173

    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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    Indian Pharma firms Expand in US Cancer Generics Market
    Indian Pharma firms Expand in US Cancer Generics Market

    16 Apr 2025

    // BUSINESS STD

    https://www.business-standard.com/industry/news/indian-pharma-companies-grows-footprint-in-us-cancer-generics-market-125041601165_1.html

    BUSINESS STD
    16 Apr 2025
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    Cipla gets USFDA nod for Protein-bound Paclitaxel Injection
    Cipla gets USFDA nod for Protein-bound Paclitaxel Injection

    14 Apr 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/drug-approval/cipla-receives-usfda-approval-for-protein-bound-paclitaxel-for-injectable-suspension-17013

    INDPHARMAPOST
    14 Apr 2025
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    Indian pharma stocks 'breathe easy' on US tariffs exemption
    Indian pharma stocks 'breathe easy' on US tariffs exemption

    03 Apr 2025

    // REUTERS

    https://www.reuters.com/world/india/indian-pharma-stocks-defy-market-slump-us-tariffs-exemption-2025-04-03/

    REUTERS
    03 Apr 2025
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    Cipla and Formosa sign licensing deal for Clobetasol Suspension
    Cipla and Formosa sign licensing deal for Clobetasol Suspension

    18 Mar 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/cipla-and-formosa-sign-multi-regional-licensing-deal-for-clobetasol-suspension-302403405.html

    PR NEWSWIRE
    18 Mar 2025
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    Cipla CEO: Tariffs Should Not Dictate Indian Pharma Business
    Cipla CEO: Tariffs Should Not Dictate Indian Pharma Business

    03 Mar 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/tariffs-should-not-dictate-how-indian-drugmakers-do-business-cipla-ceo-says/articleshow/118633708.cms

    ECONOMICTIMES
    03 Mar 2025
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    Cipla Beats Q3 Profit View as India Offsets Weak U.S. Sales
    Cipla Beats Q3 Profit View as India Offsets Weak U.S. Sales

    28 Jan 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/indias-cipla-beats-q3-profit-view-strong-demand-north-america-2025-01-28/

    REUTERS
    28 Jan 2025
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    ALL APIs

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    01

    Amlodipine Besylate

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

    AACR Annual meeting
    Not Confirmed
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    Amlodipine Besylate

    India

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

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    AACR Annual meeting
    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 : 2017-03-17

    Pay. Date : 2017-03-06

    DMF Number : 17032

    Submission : 2003-12-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-140 - Rev 00

    Issue Date : 2020-09-16

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10131

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2009-06-30

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-20

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7561

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (35kg/35kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Boehringer Ingelheim Korea Ltd.

    Registration Date : 2021-11-05

    Registration Number : 20101029-130-H-18-03(4)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : Virgonagar Post, Old Madras Road, Bangalore-560 049, India

     VMF Others AUDIT
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    02

    Celecoxib

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

    AACR Annual meeting
    Not Confirmed
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    Celecoxib

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-28

    Pay. Date : 2013-09-20

    DMF Number : 16671

    Submission : 2003-06-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-186 - Rev 01

    Issue Date : 2023-05-30

    Type : Chemical

    Substance Number : 2591

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10110

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2018-08-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0144nA2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7533

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Ildong Pharmaceutical Co., Ltd.

    Registration Date : 2020-09-08

    Registration Number : 20190104-209-J-128(4)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : D-7, MIDC, Industrial Area, Kurkumbh, Taluka Daund, Pune 413 802, Maharashtra State, India

     VMF Others AUDIT
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    03

    Etoposide

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

    AACR Annual meeting
    Not Confirmed
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    Etoposide

    India

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

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    AACR Annual meeting
    Not Confirmed
    • fda
    • 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
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10642

    Submission : 1993-12-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-061 - Rev 06

    Issue Date : 2024-09-17

    Type : Chemical

    Substance Number : 823

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10214

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2010-08-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-20

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7514

    Start Marketing Date : 2018-07-13

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (4kg/4kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    04

    Risedronate Sodium

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Risedronate Sodium

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • 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
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20162

    Submission : 2007-03-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-130 - Rev 00

    Issue Date : 2020-04-28

    Type : Chemical

    Substance Number : 2572

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10141

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2011-09-07

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0144nA2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7653

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    05

    Alendronate Sodium

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Alendronate Sodium

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-12-15

    Pay. Date : 2019-12-11

    DMF Number : 14334

    Submission : 1999-08-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-126 - Rev 04

    Issue Date : 2018-08-29

    Type : Chemical

    Substance Number : 1564

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0144nA2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7525

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    06

    Cetirizine Dihydrochloride

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Cetirizine Dihydrochloride

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-03-25

    Pay. Date : 2016-03-08

    DMF Number : 15145

    Submission : 2000-11-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-081 - Rev 07

    Issue Date : 2019-08-09

    Type : Chemical

    Substance Number : 1084

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-05

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0143n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7528

    Start Marketing Date : 2018-12-07

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (20kg/20kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hanol Biopharma Co., Ltd.

    Registration Date : 2011-11-18

    Registration Number : 20080829-40-C-239-12(6)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : A-33& A-37/2/2, MIDC, Patalganga-410 220, District:Raigad, Maharashtra State

     VMF Others AUDIT
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    Market
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    07

    Felodipine

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Felodipine

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11449

    Submission : 1995-04-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-022 - Rev 05

    Issue Date : 2023-04-06

    Type : Chemical

    Substance Number : 1013

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-20

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7519

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (40kg/40kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : KMS Pharmaceutical Co., Ltd.

    Registration Date : 2011-06-30

    Registration Number : 20050831-69-B-181-03(2)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : Virgonagar, Old Madras Road, Bangalore 560 049, India (Mumbai Central Mumbai 400 008 India)

     VMF Others AUDIT
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    Market
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    08

    Fluticasone Propionate

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Fluticasone Propionate

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-25

    Pay. Date : 2014-08-14

    DMF Number : 15774

    Submission : 2001-12-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-001 - Rev 02

    Issue Date : 2022-03-14

    Type : Chemical

    Substance Number : 1750

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0144nA2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7531

    Start Marketing Date : 1999-06-17

    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

    09

    Omeprazole

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Omeprazole

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12827

    Submission : 1998-01-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1997-122 - Rev 05

    Issue Date : 2015-03-19

    Type : Chemical

    Substance Number : 942

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-20

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7520

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (30kg/30kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    10

    Ondansetron Hydrochloride

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Ondansetron Hydrochloride

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15724

    Submission : 2001-11-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-279 - Rev 04

    Issue Date : 2025-02-03

    Type : Chemical

    Substance Number : 2016

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0144nA2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7540

    Start Marketing Date : 2018-11-15

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    USDMF

    read-more
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    01

    16a-bromoepiandrosterone

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    02

    Abacavir Sulfate Usp

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    03

    Abiraterone Acetate

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    04

    Abiraterone Acetate Usp

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    05

    Acalabrutinib

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    Acalabrutinib

    India
    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
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    Cipla

    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-06-03

    Pay. Date : 2021-04-16

    DMF Number : 35762

    Submission : 2021-05-03

    Status : Active

    Type : II

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    Market
    Place

    06

    Acalabrutinib Maleate

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    07

    Acyclovir

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    08

    Adefovir Dipivoxil

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    09

    Albendazole (b) Usp

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    Albendazole (b) Usp

    India
    arrow
    AACR Annual meeting
    Not Confirmed
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    Cipla

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-02-13

    Pay. Date : 2016-09-29

    DMF Number : 30967

    Submission : 2016-10-28

    Status : Active

    Type : II

    blank

    Product
    Web Link

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    Market
    Place

    10

    Albendazole Usp

    India
    AACR Annual meeting
    Not Confirmed
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    CEP/COS

    read-more
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    01

    Abacavir sulfate

    CEP/COS

    AACR Annual meeting
    Not Confirmed
    arrow

    02

    Alfuzosin hydrochloride

    CEP/COS

    AACR Annual meeting
    Not Confirmed
    arrow

    03

    Amlodipine besilate

    CEP/COS

    AACR Annual meeting
    Not Confirmed
    arrow

    04

    Amlodipine besilate, Process II

    CEP/COS

    AACR Annual meeting
    Not Confirmed
    arrow

    05

    Anastrozole

    CEP/COS

    AACR Annual meeting
    Not Confirmed
    arrow

    06

    Azelastine hydrochloride

    CEP/COS

    AACR Annual meeting
    Not Confirmed
    arrow

    07

    Beclometasone dipropionate

    CEP/COS

    AACR Annual meeting
    Not Confirmed
    arrow

    08

    Bicalutamide

    CEP/COS

    AACR Annual meeting
    Not Confirmed
    arrow

    09

    Budesonide

    CEP/COS

    AACR Annual meeting
    Not Confirmed
    arrow

    10

    Budesonide, Process II, micronised

    CEP/COS

    AACR Annual meeting
    Not Confirmed
    arrow
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    JDMF

    read-more
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    01

    Abiraterone Acetate

    JDMF

    AACR Annual meeting
    Not Confirmed
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    Abiraterone Acetate

    India
    arrow
    AACR Annual meeting
    Not Confirmed
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    Cipla

    Registration Number : 304MF10088

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400...

    Initial Date of Registration : 2022-06-22

    Latest Date of Registration : 2022-06-22

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    Market
    Place

    02

    Amlodipine besylate

    JDMF

    AACR Annual meeting
    Not Confirmed
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    Amlodipine besylate

    India
    arrow
    AACR Annual meeting
    Not Confirmed
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    Cipla

    Registration Number : 221MF10131

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400...

    Initial Date of Registration : 2009-06-30

    Latest Date of Registration : 2021-05-20

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    Market
    Place

    03

    Celecoxib

    JDMF

    AACR Annual meeting
    Not Confirmed
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    Celecoxib

    India
    arrow
    AACR Annual meeting
    Not Confirmed
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    Cipla

    Registration Number : 230MF10110

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400...

    Initial Date of Registration : 2018-08-20

    Latest Date of Registration : 2018-08-20

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    Market
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    04

    Efinaconazole

    JDMF

    AACR Annual meeting
    Not Confirmed
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    Efinaconazole

    India
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    AACR Annual meeting
    Not Confirmed
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    Cipla

    Registration Number : 302MF10122

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400...

    Initial Date of Registration : 2020-10-05

    Latest Date of Registration : 2020-10-05

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    Market
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    05

    Etoposide

    JDMF

    AACR Annual meeting
    Not Confirmed
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    Etoposide

    India
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    AACR Annual meeting
    Not Confirmed
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    Cipla

    Registration Number : 222MF10214

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400...

    Initial Date of Registration : 2010-08-05

    Latest Date of Registration : 2010-08-05

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    Market
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    06

    Oseltamivir Phosphate

    JDMF

    AACR Annual meeting
    Not Confirmed
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    Oseltamivir Phosphate

    India
    arrow
    AACR Annual meeting
    Not Confirmed
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    Cipla

    Registration Number : 304MF10109

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400...

    Initial Date of Registration : 2022-08-03

    Latest Date of Registration : 2022-08-03

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    07

    Sodium risedronate hydrate

    JDMF

    AACR Annual meeting
    Not Confirmed
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    Sodium risedronate hydrate

    India
    arrow
    AACR Annual meeting
    Not Confirmed
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    Cipla

    Registration Number : 223MF10141

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400...

    Initial Date of Registration : 2011-09-07

    Latest Date of Registration : 2018-08-02

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    NDC API

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    01

    ABACAVIR SULFATE

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    ABACAVIR SULFATE

    India
    arrow
    AACR Annual meeting
    Not Confirmed
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    Cipla

    NDC Package Code : 53104-7558

    Start Marketing Date : 2018-04-05

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    Market
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    02

    ALBENDAZOLE

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    ALBENDAZOLE

    India
    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
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    Cipla

    NDC Package Code : 53104-7736

    Start Marketing Date : 2017-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    03

    ALBUTEROL SULFATE

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    ALBUTEROL SULFATE

    India
    arrow
    AACR Annual meeting
    Not Confirmed
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    Cipla

    NDC Package Code : 53104-7506

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (30kg/30kg)

    Marketing Category : BULK INGREDIENT

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    Market
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    04

    ALENDRONATE SODIUM

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    ALENDRONATE SODIUM

    India
    arrow
    AACR Annual meeting
    Not Confirmed
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    Cipla

    NDC Package Code : 53104-7525

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    05

    ALOSETRON HYDROCHLORIDE

    India
    AACR Annual meeting
    Not Confirmed
    arrow

    ALOSETRON HYDROCHLORIDE

    India
    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
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    Cipla

    NDC Package Code : 53104-7658

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    AMBRISENTAN

    India
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    AMBRISENTAN

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    NDC Package Code : 53104-7702

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    AMLODIPINE BESYLATE

    India
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    AMLODIPINE BESYLATE

    India
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    NDC Package Code : 53104-7561

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (35kg/35kg)

    Marketing Category : BULK INGREDIENT

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    08

    ANAGRELIDE HYDROCHLORIDE

    India
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    ANAGRELIDE HYDROCHLORIDE

    India
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    Cipla

    NDC Package Code : 53104-7537

    Start Marketing Date : 2018-07-13

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (0.4kg/.4kg)

    Marketing Category : BULK INGREDIENT

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    ANASTROZOLE

    India
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    ANASTROZOLE

    India
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    Cipla

    NDC Package Code : 53104-7627

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    ARFORMOTEROL TARTRATE

    India
    AACR Annual meeting
    Not Confirmed
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    ARFORMOTEROL TARTRATE

    India
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    Cipla

    NDC Package Code : 53104-7731

    Start Marketing Date : 2017-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    ALBENDAZOLE

    India
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    India
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    03

    FENBENDAZOLE

    India
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    LISTED APIs

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    Abacavir Sulfate

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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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    Abacavir Sulfate

    India
    AACR Annual meeting
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    Abacavir Sulfate

    India
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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.

    About the Company : Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a lead...

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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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    abiraterone

    India
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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.

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    Acalabrutinib

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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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    Acalabrutinib

    India
    AACR Annual meeting
    Not Confirmed
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    Acalabrutinib

    India
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    Alendronate Sodium

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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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    Alendronate Sodium

    India
    AACR Annual meeting
    Not Confirmed
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    Alendronate Sodium

    India
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    Cipla

    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.

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    Alosetron

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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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    Alosetron

    India
    AACR Annual meeting
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    Alosetron

    India
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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.

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    Ambrisentan

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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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    Ambrisentan

    India
    AACR Annual meeting
    Not Confirmed
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    Ambrisentan

    India
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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.

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    Amlodipine Besylate

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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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    Amlodipine Besylate

    India
    AACR Annual meeting
    Not Confirmed
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    Amlodipine Besylate

    India
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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.

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    Amlodipine Mesylate

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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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    Amlodipine Mesylate

    India
    AACR Annual meeting
    Not Confirmed
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    Amlodipine Mesylate

    India
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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.

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    Anagrelide

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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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    Anagrelide

    India
    AACR Annual meeting
    Not Confirmed
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    India
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    Anastrozole

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    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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    Anastrozole

    India
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    Not Confirmed
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    Anastrozole

    India
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    Cipla

    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.

    About the Company : Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a lead...

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    Drugs in Development

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    Cipla Receives US FDA Approval for Generic Version of Abraxane

    Details:

    Paclitaxel is a microtubule inhibitor indicated for metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer & metastatic pancreatic adenocarcinoma.


    Lead Product(s): Paclitaxel

    Therapeutic Area: Oncology Brand Name: Abraxane-Generic

    Study Phase: Approved FDFProduct Type: Cytotoxic Drug

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 11, 2025

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    01

    Cipla

    India
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    Cipla

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    Lead Product(s) : Paclitaxel

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cipla Receives US FDA Approval for Generic Version of Abraxane

    Details : Paclitaxel is a microtubule inhibitor indicated for metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer & metastatic pancreatic adenocarcinoma.

    Product Name : Abraxane-Generic

    Product Type : Cytotoxic Drug

    Upfront Cash : Inapplicable

    April 11, 2025

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    Cipla Gets CDSCO Nod to Launch Inhalation Insulin

    Details:

    Afrezza (human Insulin) is the only ultra rapid-acting inhaled insulin that act as Insulin receptor agonist, indicated for the treatment of diabetes.


    Lead Product(s): Technosphere Insulin

    Therapeutic Area: Endocrinology Brand Name: Afrezza

    Study Phase: Approved FDFProduct Type: Hormone

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 11, 2024

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    Cipla

    India
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    Lead Product(s) : Technosphere Insulin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cipla Gets CDSCO Nod to Launch Inhalation Insulin

    Details : Afrezza (human Insulin) is the only ultra rapid-acting inhaled insulin that act as Insulin receptor agonist, indicated for the treatment of diabetes.

    Product Name : Afrezza

    Product Type : Hormone

    Upfront Cash : Inapplicable

    December 11, 2024

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    Cipla Gets Approval for Generic Somatuline® Depot Injection (Lanreotide)

    Details:

    Lanreotide generic injection is approved by FDA for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors.


    Lead Product(s): Lanreotide Acetate

    Therapeutic Area: Endocrinology Brand Name: Somatuline Depot-Generic

    Study Phase: Approved FDFProduct Type: Peptide

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 22, 2024

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    Cipla

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    Lead Product(s) : Lanreotide Acetate

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cipla Gets Approval for Generic Somatuline® Depot Injection (Lanreotide)

    Details : Lanreotide generic injection is approved by FDA for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors.

    Product Name : Somatuline Depot-Generic

    Product Type : Peptide

    Upfront Cash : Inapplicable

    May 22, 2024

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    Sanofi and Cipla Form Exclusive Distribution Partnership for CNS Portfolio in India

    Details:

    Cipla will distribute and promote Sanofi India's CNS product range, including Frisium (clobazam), an anti-epileptic medication, in India.


    Lead Product(s): Clobazam

    Therapeutic Area: Neurology Brand Name: Frisium

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Sanofi

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership March 27, 2024

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    Cipla

    India
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    Lead Product(s) : Clobazam

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Sanofi

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Sanofi and Cipla Form Exclusive Distribution Partnership for CNS Portfolio in India

    Details : Cipla will distribute and promote Sanofi India's CNS product range, including Frisium (clobazam), an anti-epileptic medication, in India.

    Product Name : Frisium

    Product Type : Controlled Substance

    Upfront Cash : Undisclosed

    March 27, 2024

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    Cipla Announces Launch Of Leuprolide Acetate Injection Depot (22.5Mg)

    Details:

    Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection. . It is supplied as lyophilized microspheres in a single dose vial as a kit with a prefilled syringe.


    Lead Product(s): Leuprolide Acetate

    Therapeutic Area: Oncology Brand Name: Leuprolide Acetate-Generic

    Study Phase: Approved FDFProduct Type: Peptide

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 29, 2022

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    Cipla

    India
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    Lead Product(s) : Leuprolide Acetate

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cipla Announces Launch Of Leuprolide Acetate Injection Depot (22.5Mg)

    Details : Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection. . It is supplied as lyophilized microspheres in a single dose vial as a kit with a prefilled syringe.

    Product Name : Leuprolide Acetate-Generic

    Product Type : Peptide

    Upfront Cash : Inapplicable

    November 29, 2022

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    CDSCO Panel Gives Nod for FDC Tamsulosin + Solifenacin

    Details:

    Solifenacin is a muscarinic receptor antagonist and tamsulosin is an alpha-1A and alpha-1B adrenergic receptor antagonist used to treat benign prostatic hyperplasia.


    Lead Product(s): Tamsulosin,Solifenacin Succinate

    Therapeutic Area: Urology Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 12, 2022

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    06

    Cipla

    India
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    Not Confirmed
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    Lead Product(s) : Tamsulosin,Solifenacin Succinate

    Therapeutic Area : Urology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    CDSCO Panel Gives Nod for FDC Tamsulosin + Solifenacin

    Details : Solifenacin is a muscarinic receptor antagonist and tamsulosin is an alpha-1A and alpha-1B adrenergic receptor antagonist used to treat benign prostatic hyperplasia.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    August 12, 2022

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    Cipla Receives USFDA Approval for Generic Version of Revlimid® (Lenalidomide capsules)

    Details:

    Lenalidomide is an immunomodulatory prescription drug which is indicated for several hematological malignancies in adults such as; Multiple Myeloma, Myelodysplastic syndromes, Mantle cell lymphoma, Follicular lymphoma, and Marginal Zone lymphoma.


    Lead Product(s): Lenalidomide

    Therapeutic Area: Oncology Brand Name: Lenalidomide-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 09, 2022

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    Cipla

    India
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    Not Confirmed
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    Lead Product(s) : Lenalidomide

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cipla Receives USFDA Approval for Generic Version of Revlimid® (Lenalidomide capsules)

    Details : Lenalidomide is an immunomodulatory prescription drug which is indicated for several hematological malignancies in adults such as; Multiple Myeloma, Myelodysplastic syndromes, Mantle cell lymphoma, Follicular lymphoma, and Marginal Zone lymphoma.

    Product Name : Lenalidomide-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 09, 2022

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    Cipla and DNDi Launch Child-Friendly 4-in-1 Antiretroviral Treatment for Young Children Living with HIV in South Africa

    Details:

    The ‘4-in-1’ combination contains an antiretroviral combination of Abacavir, as an alternative first-line regimen for infants and young children with HIV – in the form of granule-filled capsules.


    Lead Product(s): Abacavir,Lamivudine,Lopinavir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: ABC/3TC/LPV/r

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 14, 2022

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    Cipla

    India
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    Not Confirmed

    Cipla

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    Lead Product(s) : Abacavir,Lamivudine,Lopinavir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cipla and DNDi Launch Child-Friendly 4-in-1 Antiretroviral Treatment for Young Children Living wit...

    Details : The ‘4-in-1’ combination contains an antiretroviral combination of Abacavir, as an alternative first-line regimen for infants and young children with HIV – in the form of granule-filled capsules.

    Product Name : ABC/3TC/LPV/r

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    June 14, 2022

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    Cipla Receives Emergency Use Authorisation (EUA) to Launch Oral Anti-Viral Drug Cipmolnu® (Molnupiravir 200mg) in India for Treatment of Adult Patients...

    Details:

    Cipmolnu® (Molnupiravir 200mg), first oral antiviral approved by the UK MHRA for the treatment of mild-to-moderate COVID-19 receives EUA by permission by the Drug Controller General of India.


    Lead Product(s): Molnupiravir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Cipmolnu

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 28, 2021

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    Cipla

    India
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    Not Confirmed

    Cipla

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    Lead Product(s) : Molnupiravir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cipla Receives Emergency Use Authorisation (EUA) to Launch Oral Anti-Viral Drug Cipmolnu® (Molnup...

    Details : Cipmolnu® (Molnupiravir 200mg), first oral antiviral approved by the UK MHRA for the treatment of mild-to-moderate COVID-19 receives EUA by permission by the Drug Controller General of India.

    Product Name : Cipmolnu

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 28, 2021

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    Cipla Receives Final Approval for Lanreotide Injection

    Details:

    Company received final approval for its Lanreotide acetate-Generic Injection, from USFDA for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors.


    Lead Product(s): Lanreotide Acetate

    Therapeutic Area: Endocrinology Brand Name: Somatuline Depot-Generic

    Study Phase: Approved FDFProduct Type: Peptide

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 19, 2021

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    Cipla

    India
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    Lead Product(s) : Lanreotide Acetate

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cipla Receives Final Approval for Lanreotide Injection

    Details : Company received final approval for its Lanreotide acetate-Generic Injection, from USFDA for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors.

    Product Name : Somatuline Depot-Generic

    Product Type : Peptide

    Upfront Cash : Inapplicable

    December 19, 2021

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    FDF Dossiers

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    01

    Brand Name : Quadrimune

    South Africa
    AACR Annual meeting
    Not Confirmed
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    Brand Name : Quadrimune

    South Africa
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Originator

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : CAP

    Brand Name : Quadrimune

    Dosage Strength : 30mg

    Packaging : 120X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    02

    Brand Name : Damicava Paed

    South Africa
    AACR Annual meeting
    Not Confirmed
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    Brand Name : Damicava Paed

    South Africa
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Originator

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : DSP

    Brand Name : Damicava Paed

    Dosage Strength : 60mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    03

    Brand Name : Cipla Abacavir Oral ...

    South Africa
    AACR Annual meeting
    Not Confirmed
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    Brand Name : Cipla Abacavir Oral ...

    South Africa
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : SOL

    Brand Name : Cipla Abacavir Oral Solut...

    Dosage Strength : 20mg/ml

    Packaging : 240X1mg/ml

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    04

    Brand Name : Divudine 120/60

    South Africa
    AACR Annual meeting
    Not Confirmed
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    Brand Name : Divudine 120/60

    South Africa
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    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : TAB

    Brand Name : Divudine 120/60

    Dosage Strength : 120mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    05

    Brand Name : Divudine 120/60

    South Africa
    AACR Annual meeting
    Not Confirmed
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    Brand Name : Divudine 120/60

    South Africa
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : TAB

    Brand Name : Divudine 120/60

    Dosage Strength : 120mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    06

    Brand Name : Abacavir & Lamivudin...

    South Africa
    AACR Annual meeting
    Not Confirmed
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    Brand Name : Abacavir & Lamivudin...

    South Africa
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : TAB

    Brand Name : Abacavir & Lamivudine Cip...

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Place

    07

    Brand Name : Cipla-Abacavir 300

    South Africa
    AACR Annual meeting
    Not Confirmed
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    Brand Name : Cipla-Abacavir 300

    South Africa
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : TAB

    Brand Name : Cipla-Abacavir 300

    Dosage Strength : 300mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    08

    Brand Name : Damicava

    South Africa
    AACR Annual meeting
    Not Confirmed
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    Brand Name : Damicava

    South Africa
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : TAB

    Brand Name : Damicava

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    09

    Brand Name : ABACAVIR SULFATE

    India
    AACR Annual meeting
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
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    Regulatory Info :

    Registration Country : USA

    ABACAVIR SULFATE

    Cipla

    Dosage Form : SOLUTION; ORAL

    Brand Name : ABACAVIR SULFATE

    Dosage Strength : 20MG

    Packaging :

    Approval Date :

    Application Number : 78348

    Regulatory Info :

    Registration Country : USA

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    10

    Brand Name : ABACAVIR SULFATE

    India
    AACR Annual meeting
    Not Confirmed
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    India
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    Regulatory Info :

    Registration Country : USA

    ABACAVIR SULFATE

    Cipla

    Dosage Form : TABLET; ORAL

    Brand Name : ABACAVIR SULFATE

    Dosage Strength : 60MG

    Packaging :

    Approval Date :

    Application Number : 22547

    Regulatory Info :

    Registration Country : USA

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    01

    Brand Name : ABACAVIR SULFATE

    India
    AACR Annual meeting
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
    AACR Annual meeting
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR SULFATE

    Cipla

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : 60MG

    Approval Date :

    Application Number : 22547

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    02

    Brand Name : ABACAVIR SULFATE

    India
    AACR Annual meeting
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
    AACR Annual meeting
    Not Confirmed
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    RLD : No

    TE Code : AB

    ABACAVIR SULFATE

    Cipla

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : EQ 300MG BASE

    Approval Date : 2017-11-21

    Application Number : 78119

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    Brand Name : ABACAVIR SULFATE

    India
    AACR Annual meeting
    Not Confirmed
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    India
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    RLD :

    TE Code :

    ABACAVIR SULFATE

    Cipla

    Dosage Form : SOLUTION; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : 20MG

    Approval Date :

    Application Number : 78348

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    04

    Brand Name : ABACAVIR SULFATE AND...

    India
    AACR Annual meeting
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE AND...

    India
    AACR Annual meeting
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    RLD : No

    TE Code : AB

    ABACAVIR SULFATE; LAMIVUDINE

    Cipla

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE AND LAM...

    Dosage Strength : EQ 600MG BASE;300MG

    Approval Date : 2017-03-28

    Application Number : 91144

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ABACAVIR SULFATE; LA...

    India
    AACR Annual meeting
    Not Confirmed
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    India
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    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Cipla

    Dosage Form : TABLET, FOR SUSPENSION; ORAL

    Proprietary Name : ABACAVIR SULFATE; LAMIVU...

    Dosage Strength : 60MG; 30MG

    Approval Date :

    Application Number : 202007

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    06

    Brand Name : ABACAVIR AND LAMIVUD...

    India
    AACR Annual meeting
    Not Confirmed
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    Brand Name : ABACAVIR AND LAMIVUD...

    India
    AACR Annual meeting
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR; LAMIVUDINE

    Cipla

    Dosage Form : TABLET, FOR SUSPENSION; ORAL

    Proprietary Name : ABACAVIR AND LAMIVUDINE

    Dosage Strength : 120MG;60MG

    Approval Date :

    Application Number : 208775

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Market
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    07

    Brand Name : ACYCLOVIR

    India
    AACR Annual meeting
    Not Confirmed
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    Brand Name : ACYCLOVIR

    India
    AACR Annual meeting
    Not Confirmed
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    RLD : No

    TE Code : BX

    ACYCLOVIR

    Cipla

    Dosage Form : OINTMENT; TOPICAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 5%

    Approval Date : 2019-01-18

    Application Number : 211794

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : BX

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    08

    Brand Name : ALBENDAZOLE

    India
    AACR Annual meeting
    Not Confirmed
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    Brand Name : ALBENDAZOLE

    India
    AACR Annual meeting
    Not Confirmed
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    RLD : No

    TE Code :

    ALBENDAZOLE

    Cipla

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALBENDAZOLE

    Dosage Strength : 200MG

    Approval Date : 2018-09-21

    Application Number : 210434

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Brand Name : ALBUTEROL SULFATE

    India
    AACR Annual meeting
    Not Confirmed
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    Brand Name : ALBUTEROL SULFATE

    India
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    RLD : No

    TE Code : AB1

    ALBUTEROL SULFATE

    Cipla

    Dosage Form : AEROSOL, METERED; INHALATION

    Proprietary Name : ALBUTEROL SULFATE

    Dosage Strength : EQ 0.09MG BASE/INH

    Approval Date : 2020-04-08

    Application Number : 209959

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB1

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    Brand Name : ALBUTEROL SULFATE AN...

    India
    AACR Annual meeting
    Not Confirmed
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    Brand Name : ALBUTEROL SULFATE AN...

    India
    AACR Annual meeting
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    RLD : No

    TE Code : AN

    ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

    Cipla

    Dosage Form : SOLUTION; INHALATION

    Proprietary Name : ALBUTEROL SULFATE AND IP...

    Dosage Strength : EQ 0.083% BASE;0.017%

    Approval Date : 2007-12-31

    Application Number : 77559

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AN

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    Excipients

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    01

    Dodecyl Maltoside

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

    AACR Annual meeting
    Not Confirmed
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    Dodecyl Maltoside

    India

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

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    AACR Annual meeting
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40558

    Submission : 2024-10-17

    Status : Active

    Type : IV

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

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

    AACR Annual meeting
    Not Confirmed
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    Salcaprozate Sodium

    India

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

    arrow
    AACR Annual meeting
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39618

    Submission : 2024-10-10

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    N-DODECYL-BETA-D-MALTOSIDE

    AACR Annual meeting
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    SALCAPROZATE SODIUM

    AACR Annual meeting
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