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    Company profile for Arch Pharmalabs

    Suanfarma, at the Core of a Better Life.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    xyz-pharma-m-2025-01-20

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    EVENTS

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    About

    We are a Pharmaceutical Company aligned across two business verticals viz. Products and Services. Our Products business comprises manufacture and sale of APIs and Intermediates to innovator and generic pharmaceutical players in both Domestic and International markets including the regulated markets.

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    Titanic Building, 3rd Floor, Tex Centre, Off Saki Vihar Road, Chandivali, Andh...
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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: 4926

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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: 4652

    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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    Commerce ministry begins anti-dumping probe against ursodeoxycholic acid
    Commerce ministry begins anti-dumping probe against ursodeoxycholic acid

    28 Jan 2022

    // PHARMABIZ

    http://www.pharmabiz.com/NewsDetails.aspx?aid=145460&sid=1

    PHARMABIZ
    28 Jan 2022
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    Arch Pharmalabs, Orochem partner for SMB platform in pharma & other applications
    Arch Pharmalabs, Orochem partner for SMB platform in pharma & other applications

    21 Jan 2022

    // PHARMABIZ

    http://www.pharmabiz.com/NewsDetails.aspx?aid=145364&sid=2

    PHARMABIZ
    21 Jan 2022
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    Arch Pharmalabs ties up with Orochem Technologies
    Arch Pharmalabs ties up with Orochem Technologies

    21 Jan 2022

    // EXPRESS PHARMA

    https://www.expresspharma.in/arch-pharmalabs-ties-up-with-orochem-technologies/

    EXPRESS PHARMA
    21 Jan 2022
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    India initiates anti-dumping probe against Chinese pharma chemical
    India initiates anti-dumping probe against Chinese pharma chemical

    05 Aug 2021

    // ECONOMIC TIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/india-initiates-anti-dumping-probe-against-chinese-pharma-chemical/articleshow/85015543.cms

    ECONOMIC TIMES
    05 Aug 2021
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    Neuland Laboratories acquires Arch Pharma Labs
    Neuland Laboratories acquires Arch Pharma Labs

    12 Dec 2017

    // INDIAINFOLINE

    https://www.indiainfoline.com/article/news-top-story/neuland-laboratories-acquires-arch-pharma-labs-117121300271_1.html

    INDIAINFOLINE
    12 Dec 2017
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    Japanese Companies Make Cautious Return to Indian Pharma Market
    Japanese Companies Make Cautious Return to Indian Pharma Market

    04 Jan 2017

    // Divya Rajagopal ECONOMIC TIMES

    http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/japanese-companies-make-cautious-return-to-indian-pharma-market/articleshow/56320837.cms

    Divya Rajagopal ECONOMIC TIMES
    04 Jan 2017
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    ALL APIs

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    01

    Piroxicam

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Piroxicam

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2013-09-04

    Pay. Date : 2013-08-27

    DMF Number : 9118

    Submission : 1991-05-13

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2000-034 - Rev 11

    Issue Date : 2024-02-01

    Type : Chemical

    Substance Number : 944

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10166

    Registrant's Address : 505 Hyde Park, Chandivali Junction, Saki Vihar Road, Andheri East, Mumbai 400072, Maharashtra, India

    Initial Date of Registration : 2009-07-30

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2020-05-27

    Valid Till : 2023-05-24

    Written Confirmation Number : WC-254

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22365-114

    Start Marketing Date : 2010-01-11

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Ursodeoxycholic Acid

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Ursodeoxycholic Acid

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2021-03-25

    Pay. Date : 2020-12-24

    DMF Number : 33410

    Submission : 2018-12-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-029 - Rev 05

    Issue Date : 2024-06-17

    Type : Chemical and TSE

    Substance Number : 1275

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-03-08

    Valid Till : 2026-12-02

    Written Confirmation Number : WC-0058

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22365-012

    Start Marketing Date : 2018-12-17

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Amlodipine Besylate

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Amlodipine Besylate

    India

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

    arrow
    BIO Partnering at JPM
    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 : 23632

    Submission : 2010-05-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-161 - Rev 00

    Issue Date : 2018-03-29

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2020-05-27

    Valid Till : 2023-05-24

    Written Confirmation Number : WC-254

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    04

    Atorvastatin

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Atorvastatin

    India

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

    arrow
    BIO Partnering at JPM
    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 : 21985

    Submission : 2008-09-15

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-129 - Rev 02

    Issue Date : 2024-02-09

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-03-08

    Valid Till : 2026-12-02

    Written Confirmation Number : WC-0058

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22365-004

    Start Marketing Date : 2009-01-05

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Diclofenac Sodium

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Diclofenac Sodium

    India

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

    arrow
    BIO Partnering at JPM
    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 CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2002-022 - Rev 06

    Issue Date : 2023-12-04

    Type : Chemical

    Substance Number : 1002

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10084

    Registrant's Address : 505 Hyde Park, Chandivali Junction Saki Vihar Road, Andheri East, Mumbai 400072, India

    Initial Date of Registration : 2021-06-03

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2020-05-27

    Valid Till : 2023-05-24

    Written Confirmation Number : WC-254

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    Stock Recap
    #PipelineProspector

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    06

    Meloxicam

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Meloxicam

    India

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

    arrow
    BIO Partnering at JPM
    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 : 15926

    Submission : 2002-04-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-283 - Rev 02

    Issue Date : 2024-01-05

    Type : Chemical

    Substance Number : 2373

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2020-05-27

    Valid Till : 2023-05-24

    Written Confirmation Number : WC-254

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22365-116

    Start Marketing Date : 2010-01-11

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    #PipelineProspector

    Market
    Place

    07

    Gemcitabine

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Gemcitabine

    India

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

    arrow
    BIO Partnering at JPM
    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 : 23633

    Submission : 2010-03-31

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2011-023 - Rev 01

    Issue Date : 2014-04-25

    Type : Chemical

    Substance Number : 2306

    Status : Withdrawn by EDQM F...

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Market
    Place

    08

    Gemcitabine

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Gemcitabine

    India

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

    arrow
    BIO Partnering at JPM
    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 : 23801

    Submission : 2010-05-26

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2011-025 - Rev 01

    Issue Date : 2014-04-25

    Type : Chemical

    Substance Number : 2306

    Status : Withdrawn by EDQM F...

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Ibuprofen

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Ibuprofen

    India

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 9119

    Submission : 1991-05-13

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-114 - Rev 03

    Issue Date : 2014-04-15

    Type : Chemical

    Substance Number : 721

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Lamivudine

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Lamivudine

    India

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21548

    Submission : 2008-04-17

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-362 - Rev 00

    Issue Date : 2021-09-14

    Type : Chemical

    Substance Number : 2217

    Status : Valid

     JDMF EU-WC NDC KDMF 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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    USDMF

    read-more
    read-more

    01

    3-2- Chlorophenyl-5-methyl Isoxazole...

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    02

    3-phenyl-5-methyl Isoxazole-4-carbon...

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    03

    Amlodipine Besylate Usp

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    04

    Atorvastatin Calcium Crystalline

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    05

    Atorvastatin Calcium Crystalline Usp...

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    06

    Ats-8 / (4r-cis)-1, 1-dimethylethyl-...

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    07

    Atv-1/(4r-cis)-1, 1-dimethylethyl 6-...

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    08

    Benztropine Mesylate Usp

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    09

    Citalopram Hydrobromide

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    10

    Citalopram Hydrobromide Usp (cyano R...

    India
    BIO Partnering at JPM
    Not Confirmed
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    CEP/COS

    read-more
    read-more

    01

    Aceclofenac

    CEP/COS

    PharmaVenue
    Not Confirmed
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    02

    Amlodipine besilate

    CEP/COS

    PharmaVenue
    Not Confirmed
    arrow

    03

    Atorvastatin calcium

    CEP/COS

    PharmaVenue
    Not Confirmed
    arrow

    04

    Diclofenac sodium

    CEP/COS

    PharmaVenue
    Not Confirmed
    arrow

    05

    Gemcitabine hydrochloride, Product code:...

    CEP/COS

    PharmaVenue
    Not Confirmed
    arrow

    06

    Gemcitabine hydrochloride, Product code:...

    CEP/COS

    PharmaVenue
    Not Confirmed
    arrow

    07

    Ibuprofen

    CEP/COS

    PharmaVenue
    Not Confirmed
    arrow

    08

    Lamivudine

    CEP/COS

    PharmaVenue
    Not Confirmed
    arrow

    09

    Meloxicam

    CEP/COS

    PharmaVenue
    Not Confirmed
    arrow

    10

    Perindopril tert-butylamine

    CEP/COS

    PharmaVenue
    Not Confirmed
    arrow
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    Contact Arch Pharmalabs and get a quotation

    Arch Pharmalabs is a supplier offers 55 products (APIs, Excipients or Intermediates).

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