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    Australian Register of Therapeutic Goods list of Approved Drug Products of Cipla. Original Data : Therapeutic Goods Administration Website

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    Veranova: A CDMO that manages complexity with confidence.

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    About

    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]
    “We’re unlocking life-changing potential in complex molecules, without sacrificing time to market”

    “We’re unlocking life-changing potential in complex molecules, without sacrificing time to market”

    This week, SpeakPharma interviews Mike Riley, CEO of Veranova, a leading contract development and manufacturing organization (CDMO) confidently mastering complex APIs as it marks its second year as an independent company. Riley discusses Veranova’s key achievements, including a US$ 30 million investment in their Devens, Massachusetts (US) site to expand capabilities in antibody-drug conjugates (ADCs) and highly potent APIs (HPAPIs), and how it is navigating the increasing complexity of molecules. 🔑 HIGHLIGHTS// Veranova’s key achievements / navigating the increasing complexity of molecules Veranova is celebrating its second year as a stand-alone company. Can you share Veranova’s key milestones and achievements in its first two years? We have achieved incredible milestones over the last two years, thanks to the dedication and hard work of our team. Our first 12 months focused on establishing ourselves as an independent CDMO by building on the 50 years of expertise that we brought with us. In addition, we expanded our capabilities and applied a more agile approach available to us as a company singularly focused on life sciences. This has allowed us to move into our second year with clear and strategic goals for generating growth in our sites, people, capabilities, and offerings. Since being appointed as CEO in May 2023, I’ve had the pleasure of witnessing some exciting growth milestones of my own. Most recently, we announced an estimated US$ 30 million investment in our Devens, Massachusetts, site. This expansion will allow us to build upon existing development and manufacturing capabilities in ADCs and HPAPIs that will address the growing demand for strong US-based capacity in these key drug modalities. We also appointed our Advisory Board, thereby bolstering Veranova’s in-house expertise. Made up of four distinguished leaders in pharma and biopharma – including Dr. Carolyn Bertozzi, the 2022 Nobel Laureate in Chemistry – the Board has provided thought-leadership, guidance and expertise as we develop and execute our strategic growth and ideas. We were also proud to be recognized as one of the Society of Chemical Manufacturers and Affiliates’ 12 companies for industry-leading safety programs in 2023 and as a part of the Medicine Maker’s Power List in 2024. 🔑 HIGHLIGHTS// US$ 30 million investment in our Devens, Massachusetts, site / appointed our Advisory Board Molecules are becoming increasingly complex. Can you elaborate on how Veranova’s current capabilities are strategically designed to address this trend in the coming years? The pharmaceutical pipeline is witnessing an increasing number of complex and highly potent molecules. This trend is driven by the demand for more targeted, patient-centric therapeutics and the focus on innovative modalities such as ADCs and other bioconjugates. At Veranova, our expertise, world-class facilities, and scientific excellence enable us to provide our customers with the clarity and solutions needed to manage this development and manufacturing complexity and ultimately deliver the required treatments to customers and patients. Our people are key to this approach. We have an expert team ready to collaborate with customers at any point, from early development through large-scale commercial production. Our services include world-leading crystallization development, process development, and specialized manufacturing expertise for complex synthetic molecules, including those requiring chromatography capabilities. In many cases, we can provide all these under one roof. Our service offering to our customers is also based on the foundational element of strong quality and compliance systems. We operate multiple facilities approved by the US FDA, UK’s MHRA and other regulatory authorities and are continually focused on ways to strengthen our global quality management system. Looking ahead, we are focused on continually investing in our facilities and team to meet growing complexity, as evidenced by our recent announcement of new investment in our Devens site. This investment signals our commitment to providing state-of-the-art capacity and capabilities to enable these next-generation therapies to reach patients. It is a key milestone as we advance Veranova’s broader growth strategy. 🔑 HIGHLIGHTS// provide our customers with clarity and solutions / world-leading crystallization development / expertise for complex synthetic molecules / strong quality and compliance systems How is Veranova approaching the challenge of designing and manufacturing effective linker molecules for ADCs? As a leader in complex linker-payload synthesis, Veranova is committed to unlocking the life-changing potential of ADCs without letting their complexities slow down the development of much-needed cancer therapies. ADCs are intricate, multi-component molecules that require extensive expertise and agile collaboration to overcome unique development challenges. With over a decade of experience in ADC linker-payload systems, we have developed the ability to anticipate challenges and avoid common pitfalls. The ADC linker-payload components are complex structures that are difficult to crystallize and require specialized high-potent handling. Veranova’s differentiated combination of world-leading crystallization development capabilities, complex synthesis experience, chromatography expertise and high-potent-handling experience put us in a unique position to solve these challenges for customers and speed their products to the clinic. We prioritize getting it right the first time, minimizing change orders and ensuring high-quality results. We have developed a robust phase-appropriate strategy that is backed by state-of-the-art analytical equipment and regulatory procedures to ensure our partners can rapidly progress their ADC projects from pre-clinical to commercialization. 🔑 HIGHLIGHTS// unlocking the life-changing potential of ADCs / ensuring our partners can rapidly progress their ADC projects Can you specify how Veranova is using artificial intelligence (AI) to optimize manufacturing processes that can reduce costs and environmental footprint as well as speed up development? In May 2024, Veranova announced a partnership with Phorum.AI to leverage AI to optimize pharmaceutical manufacturing processes. This collaboration aims to enable the rapid development of processes that can drive efficiency and reduce costs while maximizing environmental sustainability. Our goal is to combine Veranova’s extensive empirical manufacturing dataset of owned APIs and drug master files with Phorum.AI’s computational chemistry engine in order to create a more powerful process-development tool for the benefit of Veranova’s and Phorum’s customers. At Veranova, we are constantly looking to employ innovative technologies and approaches to improve efficiency, accelerate time to market and reduce environmental footprint. We have the means to work with a variety of partners who have unique project requirements, without sacrificing time to market.  🔑 HIGHLIGHTS// partnership with Phorum.AI / create a more powerful process-development tool / improve efficiency, accelerate time to market and reduce environmental footprint

    Impressions: 1891

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    #SpeakPharma With Veranova
    10 Sep 2024
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    VLOG #PharmaReel

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

    BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

    Over the last two years, there has been a significant surge in layoffs by pharmaceutical and biotech companies. The trend spilled over to 2024. Data compiled by PharmaCompass indicates that between January and early-September, around 150 companies had implemented layoffs. Bristol Myers Squibb (BMS) tops the list of companies that downsized, with a staggering 2,284 job cuts. Bayer stood second at 1,816 retrenchments, followed by Takeda Pharmaceuticals at 1,155. Johnson & Johnson’s spin-off Kenvue is slashing over 1,000 jobs this year, while Roche subsidiary Genentech is cutting 529 positions, and Novartis is going ahead with its multi-year restructuring, and cutting another 770 jobs. One of the primary drivers of layoffs has been the need for companies to streamline operations and reduce costs. Many firms have faced financial pressures due to reasons such as declining revenues, increased competition, and the high costs associated with drug development. The current wave of layoffs has encompassed geographies – from traditional pharma strongholds like New Jersey, biotech hubs in Massachusetts and California, to Europe (particularly Germany and Switzerland). This is not to suggest that job cuts are a norm. Certain segments have been experiencing substantial growth and job creation. This includes companies like Eli Lilly and Novo Nordisk that have experienced remarkable growth due to the efficacy of their glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that treats type 2 diabetes and obesity.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) BMS cuts 2,284 jobs to meet cost targets, Bayer hands pink slips to 1,816 employees Several large drugmakers have announced job cuts this year in order to meet their cost cutting goals, or as part of their restructuring exercise. BMS’ revenue had declined from US$ 46.2 billion in 2022 to US$ 45 billion in 2023. The financial pressure has compelled it to cut 2,284 jobs so far in this year, a move that sent shockwaves through the industry. Overall, BMS hopes to save approximately US$ 1.5 billion in costs by 2025 through this “strategic productivity initiative”. In Europe, Swiss-based companies like Novartis and Roche have announced substantial job cuts, while Bayer is reducing its workforce globally.  Bayer is laying off 1,816 employees worldwide, including 150 in Basel, Switzerland. A majority of these are management roles as the German drugmaker seeks to target € 500 million (US$ 557 million) in cost savings in 2024 and € 2 billion (US$ 2.23 billion) in 2026. Japanese drugmaker Takeda plans to eliminate 1,155 positions, including 324 jobs in San Diego and 641 in Massachusetts. Takeda is also winding down production and R&D operations in Austria, resulting in 190 job losses. Starting next month, Genentech, a Roche subsidiary, will lay off 93 employees in San Francisco. Earlier this year, Genentech trimmed roughly 3 percent of its workforce across several departments, impacting 436 employees. Roche also laid off around 340 employees in its product development team. Novartis has been undergoing a significant restructuring exercise since 2022, when it announced 8,000 job cuts in its global workforce. This year, it announced an additional 770 job cuts in its product development organization, separate from the previous reductions. Once again, it was workforces in Switzerland (440 job cuts) and US (269 job cuts) that bore the brunt. Tylenol and Band-Aid maker Kenvue, which spun off from J&J last year, announced plans to cut 920 jobs, representing about 4 percent of its global workforce. Additionally, the company will lay off 51 employees in New Jersey and 84 in California. These layoffs are part of Kenvue’s efforts to adjust its cost structure and become more competitive.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Perrigo, Emergent Bio, Catalent, BioMarin trim workforces amid strategic shifts Several mid-size companies too are under tremendous cost pressures, with some of them feeling the need to reinvent themselves for the future. In February this year, Perrigo had embarked on ‘Project Energize’, a three-year initiative aimed at boosting organizational agility and achieving long-term success. As part of this project, Perrigo is cutting costs and laying off 6 percent of its staff, which translates into nearly 550 employees. CDMO-turned-biopharma Emergent BioSolutions plans to reduce its workforce by about 300 employees. The Maryland-based multinational is closing its Baltimore-Bayview drug substance manufacturing facility and its Rockville drug product facility in the state. Rare disease biotech BioMarin laid off 395 employees globally, about 12 percent of its workforce, as part of “organizational redesign efforts” to prioritize its new strategy with its hemophilia A gene therapy Roctavian and to preserve cash. Drug-delivery specialist Catalent has also been significantly impacted by restructuring efforts ever since it announced 1,100 layoffs in December. It had then attributed its fall in revenue to declining Covid-related sales, but had also noted that future GLP-1 manufacturing revenues could help stabilize its finances. True enough — it subsequently announced that it is in the process of being acquired by Novo Nordisk’s parent company for US$ 16.5 billion. However, Catalent reported reducing its headcount by an additional 300 in the fourth quarter of 2023.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Pfizer job cuts continue to trickle in; Lykos, Lyra downsize after pipeline setbacks Clinical trial failures and financial constraints have also played a significant role in this year’s wave of layoffs. At Pfizer, job cuts continued to trickle in, with some estimates putting the number at 1,500 employees in 2024. These include 285 at its vaccine R&D site in New York, and 52 in San Francisco. The Comirnaty maker also pulled the plug on a long-anticipated, near-complete Seagen drug manufacturing plant in Everett, Washington. About 120 employees at the site were let go.  It has been a tumultuous time for Lykos Therapeutics, following the US Food and Drug Administration’s rejection of its MDMA-assisted therapy for post-traumatic stress disorder. Lykos announced laying off 75 percent of its staff (i.e. 75 employees). Its founder, who had spent 38 years working on the therapy, left the company and so did its CEO. However, Lykos has not given up and has roped in a Janssen veteran as senior medical advisor to get the therapy past the finish line. Similarly, Lyra Therapeutics is laying off 75 percent of its workforce (i.e. 87 employees) following disappointing late-stage results for its implant to treat chronic rhino-sinusitis. The retrenchments include its chief technology officer.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Our view Technology, regulatory and pricing pressures are shaping strategies of pharmaceutical companies. The drive to do more with less could accelerate the adoption of artificial intelligence, machine learning, and automation in drug discovery and development processes. The employment landscape is certainly evolving. We foresee significant changes in the skills required for pharmaceutical and biotech careers, with a growing emphasis on data science and computational biology.
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    Impressions: 720

    https://www.pharmacompass.com/radio-compass-blog/bms-bayer-takeda-pfizer-downsize-to-combat-cost-pressures-meet-restructuring-plans

    #PharmaFlow by PHARMACOMPASS
    19 Sep 2024
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    NEWS #PharmaBuzz

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    Cipla Vice Chairman MK Hamied Resigns, Son Kamil Hamied Joins the Board
    Cipla Vice Chairman MK Hamied Resigns, Son Kamil Hamied Joins the Board

    03 Sep 2024

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/ciplas-mk-hamied-resigns-from-the-company-due-to-health-reasons/articleshow/113029354.cms

    ECONOMICTIMES
    03 Sep 2024
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    Cipla expects to commence supplies to US from China plant later this year
    Cipla expects to commence supplies to US from China plant later this year

    28 Jul 2024

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/cipla-expects-to-commence-supplies-to-us-from-china-plant-later-this-year/articleshow/112078176.cms

    ECONOMICTIMES
    28 Jul 2024
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    Cipla's North America business revenue hits record high in Q1 at $250 million
    Cipla's North America business revenue hits record high in Q1 at $250 million

    26 Jul 2024

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/ciplas-north-america-business-revenue-hits-record-high-in-q1-at-250-million/articleshow/112040601.cms

    ECONOMICTIMES
    26 Jul 2024
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    Cipla gets Rs 773 crore demand notice from I-T department
    Cipla gets Rs 773 crore demand notice from I-T department

    17 Jul 2024

    // ECONOMIC TIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/cipla-gets-rs-773-crore-demand-notice-from-it-department/articleshow/111784857.cms

    ECONOMIC TIMES
    17 Jul 2024
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    As monsoon sets in, respiratory, malaria drugs see demand rise
    As monsoon sets in, respiratory, malaria drugs see demand rise

    08 Jul 2024

    // ECONOMIC TIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/as-monsoon-sets-in-respiratory-malaria-drugs-see-demand-rise/articleshow/111560158.cms

    ECONOMIC TIMES
    08 Jul 2024
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    FDA Issues form 483 to Cipla Goa
    FDA Issues form 483 to Cipla Goa

    26 Jun 2024

    // FDA

    https://www.fda.gov/media/179606/download

    FDA
    26 Jun 2024
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    ALL APIs

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    01

    Amlodipine Besylate

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

    BioProcess International
    Not Confirmed
    arrow

    Amlodipine Besylate

    India

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

    arrow
    BioProcess International
    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Boehringer Ingelheim Korea Co., 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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    Market
    Place

    02

    Celecoxib

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

    BioProcess International
    Not Confirmed
    arrow

    Celecoxib

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-28

    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-0144

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7533

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2024-12-31

    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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    Market
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    03

    Etoposide

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

    BioProcess International
    Not Confirmed
    arrow

    Etoposide

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10642

    Submission : 1993-12-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-061 - Rev 05

    Issue Date : 2020-04-28

    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    04

    Risedronate Sodium

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

    BioProcess International
    Not Confirmed
    arrow

    Risedronate Sodium

    India

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

    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    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-0144

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7653

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2024-12-31

    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

    BioProcess International
    Not Confirmed
    arrow

    Alendronate Sodium

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 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-0144

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7525

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2024-12-31

    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

    BioProcess International
    Not Confirmed
    arrow

    Cetirizine Dihydrochloride

    India

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

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    BioProcess International
    Not Confirmed
    • fda
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    • WHO-GMP
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    USDMF arrow-down
    ✖

    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-0143

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7528

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hanall 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
    Place

    07

    Felodipine

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

    BioProcess International
    Not Confirmed
    arrow

    Felodipine

    India

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

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    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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 : 2024-12-31

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

    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
    Place

    08

    Fluticasone Propionate

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

    BioProcess International
    Not Confirmed
    arrow

    Fluticasone Propionate

    India

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

    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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 : CEP 2020-075 - Rev 01

    Issue Date : 2024-08-16

    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-0144

    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

    BioProcess International
    Not Confirmed
    arrow

    Omeprazole

    India

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

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

    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    10

    Ondansetron Hydrochloride

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

    BioProcess International
    Not Confirmed
    arrow

    Ondansetron Hydrochloride

    India

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

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

    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 : R1-CEP 2006-279 - Rev 03

    Issue Date : 2014-07-28

    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-0144

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7540

    Start Marketing Date : 2018-11-15

    End Marketing Date : 2024-12-31

    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
    BioProcess International
    Not Confirmed
    arrow

    02

    Abacavir Sulfate Usp

    India
    BioProcess International
    Not Confirmed
    arrow

    Abacavir Sulfate Usp

    India
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Cipla

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-07-29

    Pay. Date : 2013-03-13

    DMF Number : 26299

    Submission : 2012-08-22

    Status : Active

    Type : II

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    Market
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    03

    Abiraterone Acetate

    India
    BioProcess International
    Not Confirmed
    arrow

    04

    Abiraterone Acetate Usp

    India
    BioProcess International
    Not Confirmed
    arrow

    05

    Acalabrutinib

    India
    BioProcess International
    Not Confirmed
    arrow

    Acalabrutinib

    India
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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
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    06

    Acalabrutinib Maleate

    India
    BioProcess International
    Not Confirmed
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    Acalabrutinib Maleate

    India
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
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    Cipla

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-10-30

    Pay. Date : 2023-09-22

    DMF Number : 38325

    Submission : 2023-07-14

    Status : Active

    Type : II

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    Market
    Place

    07

    Acyclovir

    India
    BioProcess International
    Not Confirmed
    arrow

    08

    Adefovir Dipivoxil

    India
    BioProcess International
    Not Confirmed
    arrow

    09

    Albendazole (b) Usp

    India
    BioProcess International
    Not Confirmed
    arrow

    Albendazole (b) Usp

    India
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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

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    Market
    Place

    10

    Albendazole Usp

    India
    BioProcess International
    Not Confirmed
    arrow
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    LISTED APIs

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    Abacavir Sulfate

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    Market
    Place

    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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    01

    Abacavir Sulfate

    India
    BioProcess International
    Not Confirmed
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    Abacavir Sulfate

    India
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    BioProcess International
    Not Confirmed
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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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    abiraterone

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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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    02

    abiraterone

    India
    BioProcess International
    Not Confirmed
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    abiraterone

    India
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    BioProcess International
    Not Confirmed
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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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    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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    03

    Acalabrutinib

    India
    BioProcess International
    Not Confirmed
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    Acalabrutinib

    India
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    BioProcess International
    Not Confirmed
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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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    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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    04

    Alendronate Sodium

    India
    BioProcess International
    Not Confirmed
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    Alendronate Sodium

    India
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    BioProcess International
    Not Confirmed
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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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    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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    05

    Alosetron

    India
    BioProcess International
    Not Confirmed
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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.

    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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    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
    BioProcess International
    Not Confirmed
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    Ambrisentan

    India
    arrow
    BioProcess International
    Not Confirmed
    • fda
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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
    BioProcess International
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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
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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
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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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