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    About

    Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in markets across emerging economies including India. The generics business services the requirements of developed markets like US and Western Europe. Our API business sells products in over 65 countries including the US, various countries in the EU, South...
    Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in markets across emerging economies including India. The generics business services the requirements of developed markets like US and Western Europe. Our API business sells products in over 65 countries including the US, various countries in the EU, South America and India. With 15 manufacturing facilities and 3 R&D centers dedicated to the goal of enriching lives across the globe.

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    Glenmark House, B. D. Sawant Marg, Chakala, Off Western Express Highway, Andhe...
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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  

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    16 Dec 2024
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    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    A watershed moment in the journey of a drug is when it transitions from being a patented, high‐priced innovator product to an affordable generic.Through an inaugural approval, or a “first generic”,  the US Food Drug Administration (FDA) permits a manufacturer to market a generic version of a brand‐name drug — a process that, when successful, grants 180 days of exclusivity to the generic sponsor. This exclusivity is especially valuable when the drug in question is a blockbuster.In FDA’s fiscal year 2024 (i.e. from October 1, 2023 to September 30, 2024), the number of first-time generic drug approvals decreased by 21.3 percent — from 89 in FY 2023 to 70 in FY 2024, the lowest in at least nine years.Lupin emerged as a frontrunner in first generics, increasing its approvals from three in FY 2023 to seven in FY 2024, Apotex and Zydus Lifesciences from four to six, and Dr. Reddy’s from two to four. In contrast, Teva, Amneal, and Sun Pharma experienced a decline.Overall, neurology led the way with 10 approvals, while immunology saw eight, including three approvals in dermatology. Oncology and cardiology/vascular disease saw six approvals each. Ophthalmology saw five while psychiatry, and infectious diseases each contributed four approvals. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Novartis’ top seller Entresto, blockbuster Tasigna among six key drugs hit by generic rivalsIn 2024, the tide turned sharply for Novartis as it lost exclusivity for six of its drugs. Among them was its blockbuster Entresto, that has generated US$ 29.2 billion in revenue so far, including US$ 7.8 billion in 2024.A combination of sacubitril and valsartan, Entresto has transformed heart failure management. Entresto was the primary driver of Novartis’ sales growth last year. It was also one of the 10 drugs selected by the Biden administration in 2023 for Medicare price negotiations. Novartis has been fighting a fierce legal battle to protect Entresto from generic competition. In 2024, Entresto’s generic saga reached a crescendo. Alembic Pharmaceuticals, Laurus Labs, and Crystal Pharmaceutical’s generic versions of Entresto received FDA approval in May last year. But the Swiss drugmaker has noted that as of January 2025, there were no Entresto generics available in the US.Novartis’ Tasigna (nilotinib) has been a cornerstone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Apotex won approvals for generics of 50 mg, 150 mg, and 200 mg of nilotinib formulations, thereby offering a more affordable option for both adult and pediatric patients. Owing to the generics, Tasigna’s sales fell 10 percent in 2024.Novartis’ Mekinist (trametinib), Votrient (pazopanib), Rydapt (midostaurin), and Promacta (eltrombopag) have long been critical treatments in oncology and hematology. With generic competition hitting these key assets, Novartis is now aggressively forging deals to strengthen its pipeline. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  FDA clears first generics for Neurocrine’s Ingrezza, Supernus’s Gocovri, ALS drugsIn psychiatry, Neurocrine Biosciences’ Ingrezza (valbenazine) capsules have carved out a niche for themselves as a first-in-class treatment for tardive dyskinesia, a movement disorder that can develop as a side effect of long-term use of antipsychotic meds. Two generics for Ingrezza from India’s Zydus and Lupin bagged FDA approval, as Ingrezza sales topped US$ 2.3 billion last year.Zydus also won first generic approval for Supernus Pharmaceuticals’ Gocovri (amantadine) extended-release capsules, which is a treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.Four companies received FDA approvals for their first generics of Mitsubishi Tanabe’s patented drug Radicava (edaravone). These are Dr. Reddy’s Laboratories, Gland Pharma (a Fosun Pharmaceutical subsidiary), Hikma and Long Grove. Radicava is a drug that treats amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Another treatment for ALS from Italfarmaco — Tiglutik (riluzole) — received a first generic when FDA okayed Alkem Laboratories riluzole oral suspension. The med helps slow disease progression. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Pfizer’s Ibrance, Gilead’s Descovy, Lilly’s Olumiant treatment come under generic pressureIn oncology, Synthon Pharmaceuticals launched its generic version of Pfizer’s Ibrance (palbociclib) tablets. Generating sales of US$ 4.4 billion in 2024, this groundbreaking CDK4/6 inhibitor is Pfizer’s best-selling cancer drug. It has transformed treatment for hormone receptor-positive, HER2-negative advanced breast cancer by halting cancer cell division and significantly extending progression-free survival when combined with endocrine therapy.Descovy, a combination of emtricitabine and tenofovir alafenamide, stands as one of the most important therapies in the fight against HIV infection and related conditions. Originally developed by Gilead Sciences, Descovy has played a pivotal role in modern antiretroviral therapy, contributing US$ 2.1 billion to Gilead’s revenue in 2024. Apotex’s first generic approval for Descovy marked its second copycat for a blockbuster drug in 2024. The other generic approval it got its hands on was for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), a blood thinner that posted sales of € 845 million (US$ 883 million) in 2023.In immunology, Eli Lilly’s Olumiant (baricitinib) has emerged as an important therapy for treating inflammatory conditions such as rheumatoid arthritis. Aurobindo Pharma bagged FDA approval for generic baricitinib tablets.Ipsen’s Somatuline Depot (lanreotide) injection, a treatment for neuroendocrine tumors and endocrine disorders that generated about € 1.07 billion (US$1.1 billion) in 2023 sales, also has a generic now, with Cipla’s subsidiary InvaGen Pharmaceuticals receiving an FDA approval. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA okays copycats for opioid withdrawal med Lucemyra, weight loss drug Qsymia, contraceptive SlyndFDA also demonstrated a focused commitment to addressing two of the nation’s biggest public health concerns — the opioid crisis and obesity. Lucemyra (lofexidine), originally developed by US WorldMeds, is a non-opioid medication indicated for mitigating symptoms associated with acute opioid withdrawal and facilitating the completion of opioid discontinuation treatment. The introduction of Indoco Remedies’ generic version is poised to expand access to this critical therapy by offering a cost-effective alternative for managing substance use disorders.Vivus’ Qsymia (phentermine/topiramate), a chronic weight management therapy, also received a first generic. Actavis’ generic for Qsymia provides a more accessible option to patients striving to lose weight. Actavis is a subsidiary of Teva.FDA also approved Lupin’s first generic version of Insud Pharma’s Slynd—a progestin‑only contraceptive containing 4 mg drospirenone for use by females of reproductive potential to prevent pregnancy. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Our viewOver the next two years, several blockbusters such as Novo Nordisk’s Ozempic (semaglutide), AstraZeneca’s Farxiga (dapagliflozin), Bristol Myers Squibb’s Revlimid (lenalidomide) and its Pfizer partnered drug Eliquis (apixaban) stand to lose their patent protection. We expect more patent litigations and some exciting innovations in the generics space.
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    https://www.pharmacompass.com/radio-compass-blog/fda-s-first-generic-approvals-slump-21-in-2024-novartis-top-seller-entresto-cancer-blockbuster-tasigna-lead-2024-patent-cliff

    #PharmaFlow by PHARMACOMPASS
    20 Feb 2025
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    NEWS #PharmaBuzz

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    Glenmark Pharmaceuticals launches Latanoprost Ophthalmic Solution
    Glenmark Pharmaceuticals launches Latanoprost Ophthalmic Solution

    14 Feb 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/glenmark-pharmaceuticals-inc-usa-launches-latanoprost-ophthalmic-solution-0-005-0-05-mgml-302377022.html

    PR NEWSWIRE
    14 Feb 2025
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    India's Glenmark Pharma Misses Profit Estimates In Q3
    India's Glenmark Pharma Misses Profit Estimates In Q3

    14 Feb 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/indias-glenmark-pharma-misses-profit-estimates-weak-north-america-sales-2025-02-14/

    REUTERS
    14 Feb 2025
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    Glenmark launches Clindamycin Phosphate Foam
    Glenmark launches Clindamycin Phosphate Foam

    13 Feb 2025

    // BUSINESS STD

    https://www.business-standard.com/markets/capital-market-news/glenmark-launches-clindamycin-phosphate-foam-1-125021200356_1.html

    BUSINESS STD
    13 Feb 2025
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    Glenmark launches generic ophthalmic solution in US market
    Glenmark launches generic ophthalmic solution in US market

    13 Feb 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-launches-generic-ophthalmic-solution-in-us-market/articleshow/118234077.cms

    ECONOMICTIMES
    13 Feb 2025
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    Glenmark, Cosmo get MHRA nod to acne treatment in UK
    Glenmark, Cosmo get MHRA nod to acne treatment in UK

    10 Feb 2025

    // BUSSINESS STD

    https://www.business-standard.com/companies/news/glenmark-cosmo-get-mhra-nod-to-market-acne-treatment-medication-in-uk-125021000609_1.html

    BUSSINESS STD
    10 Feb 2025
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    Glenmark Pharm launch of coagulation disorder drug Phytonadione
    Glenmark Pharm launch of coagulation disorder drug Phytonadione

    21 Jan 2025

    // BUSINESS STD

    https://www.business-standard.com/markets/capital-market-news/glenmark-pharma-edges-higher-after-us-launch-of-coagulation-disorder-drug-phytonadione-125012100271_1.html

    BUSINESS STD
    21 Jan 2025
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    Adapalene

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-08

    Pay. Date : 2012-11-26

    DMF Number : 18756

    Submission : 2005-09-12

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2012-207 - Rev 01

    Issue Date : 2022-12-06

    Type : Chemical

    Substance Number : 2445

    Status : Valid

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    ✖

    Registration Number : 226MF10072

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2014-03-11

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-06-07

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

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    NDC Package Code : 66039-801

    Start Marketing Date : 2005-09-12

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    02

    Esomeprazole Magnesium

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

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    DMF Review : Reviewed

    Rev. Date : 2014-06-05

    Pay. Date : 2013-03-08

    DMF Number : 20222

    Submission : 2007-01-31

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2014-258 - Rev 02

    Issue Date : 2023-02-09

    Type : Chemical

    Substance Number : 2787

    Status : Valid

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    Registration Number : 303MF10113

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2021-07-16

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2023-12-28

    Valid Till : 2026-12-28

    Written Confirmation Number : WC-0310

    Address of the Firm :

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    NDC Package Code : 66039-827

    Start Marketing Date : 2007-01-31

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : SG Biochem Co., Ltd.

    Registration Date : 2023-12-27

    Registration Number : 20230925-127-H-416-46(1)

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109, GIDC Industrial Estate Ankleshwar - 393 002, Dist. Bharuch, Gujarat State, India

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    03

    Rizatriptan Benzoate

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22676

    Submission : 2009-03-31

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2012-108 - Rev 02

    Issue Date : 2022-12-05

    Type : Chemical

    Substance Number : 2585

    Status : Valid

     JDMF arrow-down
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    Registration Number : 228MF10064

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2016-02-24

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-06-07

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

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    NDC Package Code : 66039-835

    Start Marketing Date : 2009-03-31

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    Ropinirole Hydrochloride

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

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    DMF Review : Reviewed

    Rev. Date : 2022-11-16

    Pay. Date : 2022-11-14

    DMF Number : 20593

    Submission : 2007-06-12

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2017-242 - Rev 01

    Issue Date : 2022-12-13

    Type : Chemical

    Substance Number : 2604

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10031

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2015-01-23

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-07

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 66039-853

    Start Marketing Date : 2007-06-12

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    Solifenacin Succinate

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

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    Solifenacin Succinate

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-17

    Pay. Date : 2012-12-07

    DMF Number : 22418

    Submission : 2009-01-16

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2017-249 - Rev 02

    Issue Date : 2024-04-04

    Type : Chemical

    Substance Number : 2779

    Status : Valid

     JDMF arrow-down
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    Registration Number : 306MF10112

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2024-08-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-07

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-858

    Start Marketing Date : 2009-01-16

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Astellas Pharma Korea Co., Ltd.

    Registration Date : 2024-09-04

    Registration Number : No. 4692-7-ND(3)

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109-C, GIDC Industrial Estate, Ankleshwar - 393 002, Dist. Bharuch, Gurajat State, India

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    06

    Tadalafil

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

    Biotech Digital Meet
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    Tadalafil

    India

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

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    Biotech Digital Meet
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22530

    Submission : 2009-02-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-040 - Rev 00

    Issue Date : 2022-06-29

    Type : Chemical

    Substance Number : 2606

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10055

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2019-02-25

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-12-28

    Valid Till : 2026-12-28

    Written Confirmation Number : WC-0310

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-843

    Start Marketing Date : 2009-02-16

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sangjin Corporation

    Registration Date : 2014-02-07

    Registration Number : 20140207-203-I-371-06

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar. City : Ankleshwar - 393 002, Dist : Bharuch, Gujarat State, India

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    07

    Telmisartan

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

    Biotech Digital Meet
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    Telmisartan

    India

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

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    Biotech Digital Meet
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-07-25

    Pay. Date : 2014-05-23

    DMF Number : 27804

    Submission : 2014-05-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-184 - Rev 00

    Issue Date : 2024-08-29

    Type : Chemical

    Substance Number : 2154

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10093

    Registrant's Address : Glenmark House, HDO Corporate Building, Wing A, B. D. Sawant Marg, Chakala, Off Western Express Highway, Andheri (East), Mumbai

    Initial Date of Registration : 2013-05-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-07

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-895

    Start Marketing Date : 2014-05-23

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : M-Peak Korea Co., Ltd.

    Registration Date : 2018-05-09

    Registration Number : 20180509-209-J-30

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109-GIDC Industrial Estate ANKLESHWAR-393002 Dist. Bharuch, Gujarat, India

     VMF Others AUDIT
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    08

    Voriconazole

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

    Biotech Digital Meet
    Not Confirmed
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    Voriconazole

    India

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

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    Biotech Digital Meet
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-14

    Pay. Date : 2013-12-13

    DMF Number : 24717

    Submission : 2011-03-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-102 - Rev 02

    Issue Date : 2022-12-05

    Type : Chemical

    Substance Number : 2576

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10092

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2013-05-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-12-28

    Valid Till : 2026-12-28

    Written Confirmation Number : WC-0310

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-876

    Start Marketing Date : 2011-08-12

    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 : 2020-07-21

    Registration Number : 20200721-209-J-382

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109, GIDC Industrial Estate, Ankleshwar City : Ankleshwar - 393 002, Dist : Bharuch, Gujarat State, India

     VMF Others AUDIT
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    09

    Zolpidem Tartrate

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

    Biotech Digital Meet
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    Zolpidem Tartrate

    India

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

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    Biotech Digital Meet
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-31

    Pay. Date : 2013-01-04

    DMF Number : 18164

    Submission : 2005-03-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-102 - Rev 04

    Issue Date : 2022-12-05

    Type : Chemical

    Substance Number : 1280

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10236

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2015-09-24

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-07

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-810

    Start Marketing Date : 2005-03-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Telmisartan

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

    Biotech Digital Meet
    Not Confirmed
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    Telmisartan

    India

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

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    Biotech Digital Meet
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20575

    Submission : 2007-05-25

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-028 - Rev 06

    Issue Date : 2022-12-06

    Type : Chemical

    Substance Number : 2154

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10025

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2016-02-02

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-12-28

    Valid Till : 2026-12-28

    Written Confirmation Number : WC-0310

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-895

    Start Marketing Date : 2014-05-23

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : M-Peak Korea Co., Ltd.

    Registration Date : 2018-05-09

    Registration Number : 20180509-209-J-30

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109-GIDC Industrial Estate ANKLESHWAR-393002 Dist. Bharuch, Gujarat, India

     VMF Others AUDIT
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    01

    Brand Name : ACAMPROSATE CALCIUM

    India
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    Brand Name : ACAMPROSATE CALCIUM

    India
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    Regulatory Info : DISCN

    Registration Country : USA

    ACAMPROSATE CALCIUM

    Glenmark Pharmaceuticals

    Dosage Form : TABLET, DELAYED RELEASE;...

    Brand Name : ACAMPROSATE CALCIUM

    Dosage Strength : 333MG

    Packaging :

    Approval Date : 2013-07-16

    Application Number : 202229

    Regulatory Info : DISCN

    Registration Country : USA

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    02

    Brand Name : ACETAMINOPHEN AND IB...

    India
    Biotech Digital Meet
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    Brand Name : ACETAMINOPHEN AND IB...

    India
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    Biotech Digital Meet
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    Regulatory Info : OTC

    Registration Country : USA

    ACETAMINOPHEN; IBUPROFEN

    Glenmark Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAMINOPHEN AND IBUPROF...

    Dosage Strength : 250MG;125MG

    Packaging :

    Approval Date : 2024-04-26

    Application Number : 218311

    Regulatory Info : OTC

    Registration Country : USA

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    03

    Brand Name : ACETYLCYSTEINE

    India
    Biotech Digital Meet
    Not Confirmed
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    Brand Name : ACETYLCYSTEINE

    India
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    Regulatory Info : RX

    Registration Country : USA

    ACETYLCYSTEINE

    Glenmark Pharmaceuticals

    Dosage Form : INJECTABLE;INTRAVENOUS

    Brand Name : ACETYLCYSTEINE

    Dosage Strength : 6GM/30ML (200MG/ML)

    Packaging :

    Approval Date : 2022-02-03

    Application Number : 213693

    Regulatory Info : RX

    Registration Country : USA

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    04

    Brand Name : ADAPALENE

    India
    Biotech Digital Meet
    Not Confirmed
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    Brand Name : ADAPALENE

    India
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    Regulatory Info : OTC

    Registration Country : USA

    ADAPALENE

    Glenmark Pharmaceuticals

    Dosage Form : GEL;TOPICAL

    Brand Name : ADAPALENE

    Dosage Strength : 0.1%

    Packaging :

    Approval Date : 2010-07-01

    Application Number : 91314

    Regulatory Info : OTC

    Registration Country : USA

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    05

    Brand Name : Deriva Gel

    India
    Biotech Digital Meet
    Not Confirmed
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    Brand Name : Deriva Gel

    India
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    Biotech Digital Meet
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    Regulatory Info : Generic

    Registration Country : South Africa

    Adapalene

    Glenmark Pharmaceuticals

    Dosage Form : JEL

    Brand Name : Deriva Gel

    Dosage Strength : 1mg/g

    Packaging : 30X1mg/g

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    06

    Brand Name : ADAPALENE

    India
    Biotech Digital Meet
    Not Confirmed
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    Brand Name : ADAPALENE

    India
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    Regulatory Info :

    Registration Country : USA

    ADAPALENE

    Glenmark Pharmaceuticals

    Dosage Form : GEL;TOPICAL

    Brand Name : ADAPALENE

    Dosage Strength : 0.1%

    Packaging :

    Approval Date :

    Application Number : 91314

    Regulatory Info :

    Registration Country : USA

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    07

    Brand Name : ADAPALENE AND BENZOY...

    India
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    Brand Name : ADAPALENE AND BENZOY...

    India
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    Regulatory Info : RX

    Registration Country : USA

    ADAPALENE; BENZOYL PEROXIDE

    Glenmark Pharmaceuticals

    Dosage Form : GEL;TOPICAL

    Brand Name : ADAPALENE AND BENZOYL PER...

    Dosage Strength : 0.1%;2.5%

    Packaging :

    Approval Date : 2019-11-08

    Application Number : 208108

    Regulatory Info : RX

    Registration Country : USA

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    08

    Brand Name : ALCLOMETASONE DIPROP...

    India
    Biotech Digital Meet
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    Brand Name : ALCLOMETASONE DIPROP...

    India
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    Regulatory Info : RX

    Registration Country : USA

    ALCLOMETASONE DIPROPIONATE

    Glenmark Pharmaceuticals

    Dosage Form : CREAM;TOPICAL

    Brand Name : ALCLOMETASONE DIPROPIONAT...

    Dosage Strength : 0.05%

    Packaging :

    Approval Date : 2009-06-23

    Application Number : 79061

    Regulatory Info : RX

    Registration Country : USA

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    09

    Brand Name : ALCLOMETASONE DIPROP...

    India
    Biotech Digital Meet
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    Brand Name : ALCLOMETASONE DIPROP...

    India
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    Regulatory Info : RX

    Registration Country : USA

    ALCLOMETASONE DIPROPIONATE

    Glenmark Pharmaceuticals

    Dosage Form : OINTMENT;TOPICAL

    Brand Name : ALCLOMETASONE DIPROPIONAT...

    Dosage Strength : 0.05%

    Packaging :

    Approval Date : 2009-07-30

    Application Number : 79227

    Regulatory Info : RX

    Registration Country : USA

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    10

    Brand Name : AMLODIPINE AND OLMES...

    India
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    Brand Name : AMLODIPINE AND OLMES...

    India
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    Regulatory Info : DISCN

    Registration Country : USA

    AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

    Glenmark Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : AMLODIPINE AND OLMESARTAN...

    Dosage Strength : EQ 5MG BASE;20MG

    Packaging :

    Approval Date : 2017-07-05

    Application Number : 207807

    Regulatory Info : DISCN

    Registration Country : USA

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    Contact Glenmark Pharmaceuticals and get a quotation

    Glenmark Pharmaceuticals is a supplier offers 118 products (APIs, Excipients or Intermediates).

    Find a price of Alfuzosin HCl bulk offered by Glenmark Pharmaceuticals

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