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    Company profile for Biocon

    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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    Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    About

    The Company is a pioneer in bringing the benefit of high quality, yet affordable, novel biologics and biosimilars to patients in India and other emerging markets. Today, we are India's largest and fully-integrated biopharmaceutical company that develops, manufactures and supplies advanced, life-saving biopharmaceuticals for diabetes, cancer and autoimmune conditions at price points that make them affordable and thus accessible...
    The Company is a pioneer in bringing the benefit of high quality, yet affordable, novel biologics and biosimilars to patients in India and other emerging markets. Today, we are India's largest and fully-integrated biopharmaceutical company that develops, manufactures and supplies advanced, life-saving biopharmaceuticals for diabetes, cancer and autoimmune conditions at price points that make them affordable and thus accessible.

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    Hosur Road,Electronics City,Bangalore
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    enquiries@pharmacompass.com
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

    Impressions: 4916

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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

    Radio Compass
    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities.  North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent.  Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.  
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    Impressions: 4560

    https://www.pharmacompass.com/radio-compass-blog/bms-j-j-bayer-lead-25-000-pharma-layoffs-in-2024-amylyx-fibrogen-kronos-bio-hit-by-trial-failures-cash-crunch

    #PharmaFlow by PHARMACOMPASS
    16 Jan 2025
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    NEWS #PharmaBuzz

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    Bicon`s Generics Oxcarbazepine Receives Tentative Approval in US
    Bicon`s Generics Oxcarbazepine Receives Tentative Approval in US

    08 Jan 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218442

    FDA
    08 Jan 2025
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    Biocon accused of IP theft to create cancer biotech Bicara
    Biocon accused of IP theft to create cancer biotech Bicara

    24 Oct 2024

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/biocon-accused-committing-patent-theft-create-cancer-immunotherapy-firm-bicara

    FIERCE BIOTECH
    24 Oct 2024
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    Biocon Report Explores Pathways To Increase Biosimilar Adoption
    Biocon Report Explores Pathways To Increase Biosimilar Adoption

    09 Oct 2024

    // EXPRESSPHARMA

    https://www.expresspharma.in/biocon-biologics-report-explores-pathways-to-increase-biosimilar-adoption-in-low-and-middle-income-countries/

    EXPRESSPHARMA
    09 Oct 2024
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    FDA Issues Form 483 to Biocon Sdn.
    FDA Issues Form 483 to Biocon Sdn.

    07 Oct 2024

    // FDA

    https://www.fda.gov/media/182539/download

    FDA
    07 Oct 2024
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    Biocon unit gets USFDA nod for generic drug
    Biocon unit gets USFDA nod for generic drug

    02 Sep 2024

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/biocon-unit-gets-usfda-nod-for-generic-drug/articleshow/112971315.cms

    ECONOMICTIMES
    02 Sep 2024
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    Biocon`s Generics Sacubitril; Valsartan Receives Approval in US
    Biocon`s Generics Sacubitril; Valsartan Receives Approval in US

    30 Aug 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213680

    FDA
    30 Aug 2024
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    ALL APIs

    read-moreClick the button for full data set
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    01

    Fluvastatin Sodium

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

    PharmaVenue
    Not Confirmed
    arrow

    Fluvastatin Sodium

    India

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

    arrow
    PharmaVenue
    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18493

    Submission : 2005-07-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-075 - Rev 00

    Issue Date : 2022-10-14

    Type : Chemical

    Substance Number : 2333

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10102

    Registrant's Address : 20th K. M. Hosur Road, Electronics City-560100, Bangalore, India

    Initial Date of Registration : 2013-05-13

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-04-13

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0109A

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65727-012

    Start Marketing Date : 2007-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    02

    Pravastatin

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

    PharmaVenue
    Not Confirmed
    arrow

    Pravastatin

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16048

    Submission : 2002-07-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2004-085 - Rev 06

    Issue Date : 2024-12-02

    Type : Chemical

    Substance Number : 2059

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10038

    Registrant's Address : 20th KM Hosur Road, Electronics City, Bengaluru-560 100, Karnataka, India.

    Initial Date of Registration : 2011-03-10

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-05-06

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0100N1

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65727-003

    Start Marketing Date : 2005-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2020-02-06

    Registration Number : 20151015-70-B-379-08(1)

    Manufacturer Name : Biocon Limited

    Manufacturer Address : Plot No. 2,3,4 & 5, Phase-IV, Bommasandra Jigani Link Road, Bommasandra Post Bengaluru-560 099, India

     VMF Others AUDIT
    blank

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    #PipelineProspector

    Market
    Place

    03

    Pravastatin

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

    PharmaVenue
    Not Confirmed
    arrow

    Pravastatin

    India

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

    arrow
    PharmaVenue
    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 : 2014-03-03

    Pay. Date : 2014-02-21

    DMF Number : 17447

    Submission : 2004-06-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-177 - Rev 02

    Issue Date : 2013-06-13

    Type : Chemical

    Substance Number : 2059

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10039

    Registrant's Address : 20th K. M. Hosur Road, Electronics City-560100, Bangalore, India

    Initial Date of Registration : 2011-03-10

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-04-13

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0109A

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65727-003

    Start Marketing Date : 2005-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2020-02-06

    Registration Number : 20151015-70-B-379-08(1)

    Manufacturer Name : Biocon Limited

    Manufacturer Address : Plot No. 2,3,4 & 5, Phase-IV, Bommasandra Jigani Link Road, Bommasandra Post Bengaluru-560 099, India

     VMF Others AUDIT
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    Market
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    04

    Repaglinide

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

    PharmaVenue
    Not Confirmed
    arrow

    Repaglinide

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-30

    Pay. Date : 2013-04-17

    DMF Number : 18482

    Submission : 2005-07-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2008-093 - Rev 02

    Issue Date : 2024-12-02

    Type : Chemical

    Substance Number : 2135

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10044

    Registrant's Address : 20th KM, Hosur Road, Electronics City-560100, Bengaluru, India

    Initial Date of Registration : 2019-02-13

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-04-13

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0109A

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65727-010

    Start Marketing Date : 2004-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Darim Biotech Co., Ltd.

    Registration Date : 2021-06-15

    Registration Number : 20210615-209-J-1027

    Manufacturer Name : Biocon Limited

    Manufacturer Address : 20th KM, Hosur Road, Electronics City, Bangalore-560 100, India

     VMF Others AUDIT
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    05

    Atorvastatin

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

    PharmaVenue
    Not Confirmed
    arrow

    Atorvastatin

    India

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

    arrow
    PharmaVenue
    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20207

    Submission : 2007-01-16

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-009 - Rev 04

    Issue Date : 2024-12-02

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10178

    Registrant's Address : 20th KM Hosur Road, Electronics City, Bengaluru-560 100, Karnataka, India.

    Initial Date of Registration : 2017-09-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-05-06

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0100N1

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65727-004

    Start Marketing Date : 2005-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2019-05-24

    Registration Number : 20160429-132-H-300-36(5)

    Manufacturer Name : Biocon Limited(Site-2)

    Manufacturer Address : Biocon Special Economic zone, Plot Nos. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengaluru, 560099, Karnataka, India

     VMF Others AUDIT
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    06

    Mycophenolate Mofetil

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

    PharmaVenue
    Not Confirmed
    arrow

    Mycophenolate Mofetil

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-08-17

    Pay. Date : 2018-08-10

    DMF Number : 16406

    Submission : 2003-01-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-162 - Rev 09

    Issue Date : 2024-11-27

    Type : Chemical

    Substance Number : 1700

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-04-13

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0109A

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65727-005

    Start Marketing Date : 2004-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2021-06-23

    Registration Number : 20200219-209-J-264(2)

    Manufacturer Name : Biocon Limited

    Manufacturer Address : 20th KM. Hosur Road Electronics City Bengaluru – 560100, India

     VMF Others AUDIT
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    Place

    07

    Mycophenolate Sodium

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

    PharmaVenue
    Not Confirmed
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    Mycophenolate Sodium

    India

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

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    PharmaVenue
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-14

    DMF Number : 23519

    Submission : 2010-02-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-019 - Rev 00

    Issue Date : 2023-06-06

    Type : Chemical

    Substance Number : 2813

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-04-13

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0109A

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65727-019

    Start Marketing Date : 2004-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2021-07-27

    Registration Number : 20210727-209-J-991

    Manufacturer Name : Biocon Limited

    Manufacturer Address : 20th KM. Hosur Road Electronics City Bengaluru – 560100, India

     VMF Others AUDIT
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    Market
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    08

    Pioglitazone Hydrochloride

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

    PharmaVenue
    Not Confirmed
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    Pioglitazone Hydrochloride

    India

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

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    PharmaVenue
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16635

    Submission : 2003-06-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-340 - Rev 00

    Issue Date : 2018-10-31

    Type : Chemical

    Substance Number : 2601

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-05-06

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0100N1

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65727-006

    Start Marketing Date : 2001-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Wonpung Pharmaceutical Co., Ltd.

    Registration Date : 2014-01-08

    Registration Number : 20140108-196-I-132-13

    Manufacturer Name : Biocon Limited

    Manufacturer Address : Plot No: 2-4, Phase-IV, Bommasandra-Jigani Link Road, Bangalore -560099, India

     VMF Others AUDIT
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    Market
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    09

    Rosuvastatin Calcium

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

    PharmaVenue
    Not Confirmed
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    Rosuvastatin Calcium

    India

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

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    PharmaVenue
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-21

    Pay. Date : 2012-11-21

    DMF Number : 26540

    Submission : 2012-10-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-114 - Rev 03

    Issue Date : 2024-10-21

    Type : Chemical

    Substance Number : 2631

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-06

    Valid Till : 2025-08-04

    Written Confirmation Number : WC-0038n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65727-028

    Start Marketing Date : 2016-01-13

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2023-11-22

    Registration Number : 20200107-209-J-320(7)

    Manufacturer Name : Biocon Limited

    Manufacturer Address : Plot No. 213 -215 and 216/B Phase - II, IDA, Pashamylaram Sangareddy District - 502 307 Telangana State, India

     VMF Others AUDIT
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    10

    Simvastatin

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

    PharmaVenue
    Not Confirmed
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    Simvastatin

    India

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

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    PharmaVenue
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-15

    Pay. Date : 2013-03-01

    DMF Number : 18449

    Submission : 2005-06-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2003-131 - Rev 12

    Issue Date : 2023-11-08

    Type : Chemical

    Substance Number : 1563

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-04-13

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0109A

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65727-002

    Start Marketing Date : 2000-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea United Pharmaceutical Co., Ltd.

    Registration Date : 2013-09-05

    Registration Number : 20100915-29-B-289-23(6)

    Manufacturer Name : Biocon Limited

    Manufacturer Address : Plot No.2-4, Phase IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bangalore-560 099 , India.

     VMF Others AUDIT
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    Only 10 entries up to this point, click to access all click full view read-more
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Drugs in Development

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    Biocon Biologics Receives FDA Approval for Biosimilar YESINTEK

    Details:

    Yesintek (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: Yesintek

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 02, 2024

    blank

    01

    Biocon Biologics

    India
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    Biocon Biologics

    India
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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Biocon Biologics Receives FDA Approval for Biosimilar YESINTEK

    Details : Yesintek (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.

    Brand Name : Yesintek

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    December 02, 2024

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    Biocon Signs Licensing Agreement with Tabuk Pharmaceuticals for GLP-1 Products

    Details:

    The agreement will focus on commercialising GLP-1 products for diabetes and chronic weight management in select countries of the Middle East.


    Lead Product(s): GLP-1-based Drug

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Undisclosed

    Recipient: Tabuk Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement September 27, 2024

    blank

    02

    Biocon

    India
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    Biocon

    India
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    Lead Product(s) : GLP-1-based Drug

    Therapeutic Area : Endocrinology

    Highest Development Status : Undisclosed

    Recipient : Tabuk Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Biocon Signs Licensing Agreement with Tabuk Pharmaceuticals for GLP-1 Products

    Details : The agreement will focus on commercialising GLP-1 products for diabetes and chronic weight management in select countries of the Middle East.

    Brand Name : Undisclosed

    Molecule Type : Undisclosed

    Upfront Cash : Undisclosed

    September 27, 2024

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    Biocon Unit Gets USFDA Nod For Generic Drug

    Details:

    Sacubitril and valsartan is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 02, 2024

    blank

    03

    Biocon

    India
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    Biocon

    India
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Biocon Unit Gets USFDA Nod For Generic Drug

    Details : Sacubitril and valsartan is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.

    Brand Name : Entresto-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 02, 2024

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    Biocon Settles with Janssen to Commercialise Biosimilar Products in Europe, Canada, Japan

    Details:

    The agreement aims to commercialize its Bmab 1200, a proposed biosimilar to Stelara and a monoclonal antibody medication, in Europe, the United Kingdom (UK), Canada, and Japan.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: Bmab 1200

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Johnson & Johnson Innovative Medicine

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement August 29, 2024

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    04

    Biocon Biologics

    India
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    Not Confirmed

    Biocon Biologics

    India
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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Johnson & Johnson Innovative Medicine

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Biocon Settles with Janssen to Commercialise Biosimilar Products in Europe, Canada, Japan

    Details : The agreement aims to commercialize its Bmab 1200, a proposed biosimilar to Stelara and a monoclonal antibody medication, in Europe, the United Kingdom (UK), Canada, and Japan.

    Brand Name : Bmab 1200

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    August 29, 2024

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    Biocon Biologics gets FDA nod for Yesafili™, enters U.S. ophthalmology market

    Details:

    Yesafili (aflibercept) is a PGF & VEGF-A inhibitor, its single-dose vial formulation is approved for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema.


    Lead Product(s): Aflibercept

    Therapeutic Area: Ophthalmology Brand Name: Yesafili

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 21, 2024

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    05

    Biocon Biologics

    India
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    Biocon Biologics

    India
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    Lead Product(s) : Aflibercept

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Biocon Biologics gets FDA nod for Yesafili™, enters U.S. ophthalmology market

    Details : Yesafili (aflibercept) is a PGF & VEGF-A inhibitor, its single-dose vial formulation is approved for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema.

    Brand Name : Yesafili

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    May 21, 2024

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    Biocon Signs Deal for Generic Saxenda® Commercialization in Mexico

    Details:

    Under the agreement, Biocon will obtain regulatory approval and manufacture Saxenda (liraglutide) for chronic weight management, while Medix will commercialize it in Mexico.


    Lead Product(s): Liraglutide

    Therapeutic Area: Nutrition and Weight Loss Brand Name: Saxenda-Generic

    Study Phase: ApprovedProduct Type: Peptide

    Recipient: Medix

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement May 13, 2024

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    06

    Biocon

    India
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    Biocon

    India
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    Lead Product(s) : Liraglutide

    Therapeutic Area : Nutrition and Weight Loss

    Highest Development Status : Approved

    Recipient : Medix

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Biocon Signs Deal for Generic Saxenda® Commercialization in Mexico

    Details : Under the agreement, Biocon will obtain regulatory approval and manufacture Saxenda (liraglutide) for chronic weight management, while Medix will commercialize it in Mexico.

    Brand Name : Saxenda-Generic

    Molecule Type : Peptide

    Upfront Cash : Undisclosed

    May 13, 2024

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    Biocon Receives Approval for Tacrolimus Capsules from SAHPRA

    Details:

    Tacrograf (tacrolimus) is a next-generation, capsule formulation immunosuppressent for the treatment and prevention of prophylaxis of organ rejection after transplant.


    Lead Product(s): Tacrolimus

    Therapeutic Area: Immunology Brand Name: Tacrograf

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 20, 2024

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    07

    Biocon

    India
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    Biocon

    India
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    Lead Product(s) : Tacrolimus

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Biocon Receives Approval for Tacrolimus Capsules from SAHPRA

    Details : Tacrograf (tacrolimus) is a next-generation, capsule formulation immunosuppressent for the treatment and prevention of prophylaxis of organ rejection after transplant.

    Brand Name : Tacrograf

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 20, 2024

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    Biocon Partners Biomm to Commercialise Diabetes Drug in Brazil

    Details:

    Biocon will undertake the development, manufacturing and supply of Ozempic (semaglutide) and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazil.


    Lead Product(s): Semaglutide

    Therapeutic Area: Endocrinology Brand Name: Ozempic

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Biomm

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership April 17, 2024

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    08

    Biocon

    India
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    Not Confirmed

    Biocon

    India
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    Lead Product(s) : Semaglutide

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Biomm

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Biocon Partners Biomm to Commercialise Diabetes Drug in Brazil

    Details : Biocon will undertake the development, manufacturing and supply of Ozempic (semaglutide) and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazil.

    Brand Name : Ozempic

    Molecule Type : Peptide

    Upfront Cash : Undisclosed

    April 17, 2024

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    Biocon to Obtain Approval for Diabetes Drug, Liraglutide in UK

    Details:

    Liraglutide-Generic is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is indicated for the treatment of patients with type 2 diabetes mellitus.


    Lead Product(s): Liraglutide

    Therapeutic Area: Endocrinology Brand Name: Liraglutide-Generic

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Zentiva

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 28, 2024

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    09

    Biocon

    India
    arrow
    PharmaVenue
    Not Confirmed

    Biocon

    India
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    PharmaVenue
    Not Confirmed
    • fda
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    • WHO-GMP
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    Lead Product(s) : Liraglutide

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Zentiva

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Biocon to Obtain Approval for Diabetes Drug, Liraglutide in UK

    Details : Liraglutide-Generic is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is indicated for the treatment of patients with type 2 diabetes mellitus.

    Brand Name : Liraglutide-Generic

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    March 28, 2024

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    India's Biocon to sell branded formulations business to Eris Lifesciences for $150 mln

    Details:

    The collaboration aims to support the Biocon for the commercialization of ACTIBLOK IPR 25 (metoprolol succinate). It is an approved product indicated for hypertension and angina pectoris.


    Lead Product(s): Metoprolol Succinate

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: ACTIBLOK IPR 25

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Eris Pharmaceuticals

    Deal Size: $150.0 million Upfront Cash: Undisclosed

    Deal Type: Collaboration March 13, 2024

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    Biocon Biologics

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    Biocon Biologics

    India
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    Lead Product(s) : Metoprolol Succinate

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Eris Pharmaceuticals

    Deal Size : $150.0 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    India's Biocon to sell branded formulations business to Eris Lifesciences for $150 mln

    Details : The collaboration aims to support the Biocon for the commercialization of ACTIBLOK IPR 25 (metoprolol succinate). It is an approved product indicated for hypertension and angina pectoris.

    Brand Name : ACTIBLOK IPR 25

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    March 13, 2024

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    Contact Biocon and get a quotation

    Biocon is a supplier offers 75 products (APIs, Excipients or Intermediates).

    Find a price of Fluvastatin Sodium bulk with DMF, CEP, JDMF, WC offered by Biocon

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