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    About

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

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    CONTACT DETAILS

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    India
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    1st Floor, 10/80, Rajendra Gunj, RAICHUR - 584 102 Karnataka
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    +91-8532-236494
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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  

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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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    Shilpa Medicare’s Unit Receives GMP Certificate from EMA, Austria
    Shilpa Medicare’s Unit Receives GMP Certificate from EMA, Austria

    22 Dec 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/shilpa-medicares-unit-vii-nacharam-hyderabad-receives-gmp-certificate-from-ema-austria-16564

    INDPHARMAPOST
    22 Dec 2024
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    Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI
    Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI

    28 Nov 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/shilpa-medicares-jv-oncosol-gets-usfda-approval-for-imkeldi-16490

    INDPHARMAPOST
    28 Nov 2024
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    Shilpa Medicare as Subsidiary Gets EU Nod for Blood Pressure Drug
    Shilpa Medicare as Subsidiary Gets EU Nod for Blood Pressure Drug

    19 Nov 2024

    // CNBCTV

    https://www.cnbctv18.com/market/shilpa-medicare-stock-rallies-as-subsidiary-gets-european-regulators-nod-for-blood-pressure-drug-19511446.htm

    CNBCTV
    19 Nov 2024
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    Shilpa Medicare Q2 FY25 consolidated PAT up 1,008% at Rs. 18 Cr
    Shilpa Medicare Q2 FY25 consolidated PAT up 1,008% at Rs. 18 Cr

    15 Nov 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/shilpa-medicare-q2-fy25-consolidated-pat-up-1008-at-rs-18-cr-16437

    INDPHARMAPOST
    15 Nov 2024
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    Shilpa Medicare Falls After FDA Issues 4 Observations at Facility
    Shilpa Medicare Falls After FDA Issues 4 Observations at Facility

    31 Oct 2024

    // BUSINESS STD

    https://www.business-standard.com/markets/capital-market-news/shilpa-medicare-slips-after-us-fda-issues-four-form-483-obersvations-to-bengaluru-facility-124103100642_1.html

    BUSINESS STD
    31 Oct 2024
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    Amneal and Shilpa Announce FDA Approval Of BORUZU, Ready-to-Use
    Amneal and Shilpa Announce FDA Approval Of BORUZU, Ready-to-Use

    05 Sep 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20240905166831/en

    BUSINESSWIRE
    05 Sep 2024
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    ALL APIs

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    01

    Busulfan

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

    Duphat
    Not Confirmed
    arrow

    Busulfan

    India

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

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    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-02

    Pay. Date : 2012-12-19

    DMF Number : 25491

    Submission : 2011-12-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-339 - Rev 02

    Issue Date : 2022-07-20

    Type : Chemical

    Substance Number : 542

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10027

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India

    Initial Date of Registration : 2018-02-15

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-008

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
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    Market
    Place

    02

    Capecitabine

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

    Duphat
    Not Confirmed
    arrow

    Capecitabine

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-07-07

    Pay. Date : 2013-02-21

    DMF Number : 24689

    Submission : 2011-03-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-332 - Rev 02

    Issue Date : 2023-02-07

    Type : Chemical

    Substance Number : 2762

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10131

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2017-07-19

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-001

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Masung LS Co., Ltd.

    Registration Date : 2021-04-20

    Registration Number : 20210420-209-J-850

    Manufacturer Name : Shilpa Pharma Lifesciences Limited

    Manufacturer Address : Plot Nos. 33, 33a, 40-47, Raichur Industrial Growth Centre, Chicksugur-584 134, Raichur, India

     VMF Others AUDIT
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    Market
    Place

    03

    Gemcitabine

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

    Duphat
    Not Confirmed
    arrow

    Gemcitabine

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-04-11

    Pay. Date : 2012-12-18

    DMF Number : 24136

    Submission : 2011-03-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-222 - Rev 01

    Issue Date : 2023-02-23

    Type : Chemical

    Substance Number : 2306

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10017

    Registrant's Address : 10/80, RAJENDRA GUNJ, RAICHUR-584 102, INDIA

    Initial Date of Registration : 2009-01-13

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0148

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-701

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Yeon Pharmaceutical Co., Ltd.

    Registration Date : 2012-10-05

    Registration Number : 20080110-86-D-2-05(2)

    Manufacturer Name : Shilpa Medicare Limited

    Manufacturer Address : Plot No. 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosugur - 584 170, Dist: Raichur, India

     VMF Others AUDIT
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    04

    Letrozole

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

    Duphat
    Not Confirmed
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    Letrozole

    India

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

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    Duphat
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-15

    Pay. Date : 2013-09-23

    DMF Number : 27489

    Submission : 2013-09-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-321 - Rev 01

    Issue Date : 2022-07-20

    Type : Chemical

    Substance Number : 2334

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10029

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2014-02-05

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
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    #PipelineProspector

    Market
    Place

    05

    Temozolomide

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

    Duphat
    Not Confirmed
    arrow

    Temozolomide

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-10

    Pay. Date : 2013-09-03

    DMF Number : 23479

    Submission : 2010-01-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-277 - Rev 00

    Issue Date : 2022-07-12

    Type : Chemical

    Substance Number : 2780

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10125

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2016-07-12

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0148

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-703

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2013-07-26

    Registration Number : 1414-4-ND(2)

    Manufacturer Name : Shilpa Pharma Lifesciences Limited

    Manufacturer Address : Plot No.: 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosugur- 584 170 Dist: Raichur, Karnataka, India

     VMF Others AUDIT
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    06

    Azacitidine

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

    Duphat
    Not Confirmed
    arrow

    Azacitidine

    India

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

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    Duphat
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-15

    Pay. Date : 2013-09-23

    DMF Number : 27487

    Submission : 2013-09-23

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 303MF10033

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India

    Initial Date of Registration : 2021-02-16

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-015

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samyang Holdings Co., Ltd.

    Registration Date : 2018-06-25

    Registration Number : No. 163-15-ND(1)

    Manufacturer Name : Shilpa Medicare Limited

    Manufacturer Address : Plot No.33, 33A, 40 to 47, Block C,D,E,H,I & AM, Raichur Industrial Growth Centre, Chicksugur - 584 134 Dist: Raichur, Karnataka India

     VMF Others AUDIT
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    07

    Bicalutamide

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

    Duphat
    Not Confirmed
    arrow

    Bicalutamide

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-04-04

    Pay. Date : 2013-09-23

    DMF Number : 24690

    Submission : 2011-05-11

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 225MF10084

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2013-04-23

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-004

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2021-10-25

    Registration Number : 20211025-209-J-1105

    Manufacturer Name : Shilpa Pharma Lifesciences Limited (unit-2)

    Manufacturer Address : Plot No. 33, 33A, 40 to 47, Block C,D,E,H,I & AM, Raichur Industrial Growth Centre, Chicksugur - 584 134 Dist: Raichur. Karnataka India

     VMF Others AUDIT
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    Market
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    08

    Irinotecan Hydrochloride

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

    Duphat
    Not Confirmed
    arrow

    Irinotecan Hydrochloride

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-18

    DMF Number : 23562

    Submission : 2010-02-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-156 - Rev 01

    Issue Date : 2022-07-21

    Type : Chemical

    Substance Number : 2675

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0148

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-702

    Start Marketing Date : 2022-08-11

    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 : 2021-11-23

    Registration Number : 20210210-210-J-700(1)

    Manufacturer Name : Shilpa Medicare Limited, Unit-1

    Manufacturer Address : 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B , Deosugur Industrial area, Deosugur, Raichur - 584 170, Karnataka, India

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    Market
    Place

    09

    Oxaliplatin

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

    Duphat
    Not Confirmed
    arrow

    Oxaliplatin

    India

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-10

    Pay. Date : 2013-09-23

    DMF Number : 23563

    Submission : 2010-02-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-201 - Rev 02

    Issue Date : 2022-07-20

    Type : Chemical

    Substance Number : 2017

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0148

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-704

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Shin Poong Pharmaceutical Co., Ltd.

    Registration Date : 2014-04-11

    Registration Number : 20120224-197-I-27-02(1)

    Manufacturer Name : Shilpa Pharma Lifesciences Limited

    Manufacturer Address : Plot No: 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosugur-584 170 Dist: Raichur, Karnataka, India

     VMF Others AUDIT
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    10

    Pemetrexed Disodium

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

    Duphat
    Not Confirmed
    arrow

    Pemetrexed Disodium

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-13

    Pay. Date : 2013-02-13

    DMF Number : 25102

    Submission : 2011-09-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-087 - Rev 00

    Issue Date : 2023-07-07

    Type : Chemical

    Substance Number : 3046

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-007

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2023-02-13

    Registration Number : No. 2816-4-ND(A)

    Manufacturer Name : Shilpa Pharma Lifesciences Limited

    Manufacturer Address : Plot Nos. 33, 33A, 40 to 47, Raichur Industrial Growth Centre, Wadloor Road, Chicksugur cross, Chicksugur-584 134, Raichur, Karnataka, India

     VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    Anastrozole

    India
    Duphat
    Not Confirmed
    arrow

    02

    Anastrozole Usp

    India
    Duphat
    Not Confirmed
    arrow

    03

    Axitinib

    India
    Duphat
    Not Confirmed
    arrow

    04

    Azacitidine

    India
    Duphat
    Not Confirmed
    arrow

    05

    Bendamustine Hcl

    India
    Duphat
    Not Confirmed
    arrow

    06

    Bicalutamide Usp

    India
    Duphat
    Not Confirmed
    arrow

    07

    Bortezomib

    India
    Duphat
    Not Confirmed
    arrow

    08

    Bortezomib

    India
    Duphat
    Not Confirmed
    arrow

    09

    Busulfan Usp

    India
    Duphat
    Not Confirmed
    arrow

    10

    Cabazitaxel

    India
    Duphat
    Not Confirmed
    arrow
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    CEP/COS

    read-more
    read-more

    01

    Ambroxol hydrochloride

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    02

    Buflomedil Hydrochloride

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    03

    Busulfan

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    04

    Capecitabine

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    05

    Carboplatin

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    06

    Cyclophosphamide monohydrate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    07

    Desmopressin

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    08

    Fingolimod hydrochloride

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    09

    Gemcitabine hydrochloride

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    10

    Gemcitabine hydrochloride, Process-2

    CEP/COS

    Duphat
    Not Confirmed
    arrow
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    JDMF

    read-more
    read-more

    01

    Ambroxol Hydrochloride

    JDMF

    Duphat
    Not Confirmed
    arrow

    Ambroxol Hydrochloride

    India
    arrow
    Duphat
    Not Confirmed
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    Shilpa Medicare

    Registration Number : 304MF10124

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India

    Initial Date of Registration : 2022-08-24

    Latest Date of Registration : 2022-08-24

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    Market
    Place

    02

    Anastrozole

    JDMF

    Duphat
    Not Confirmed
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    Anastrozole

    India
    arrow
    Duphat
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    Registration Number : 227MF10034

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2015-02-04

    Latest Date of Registration : 2015-02-04

    blank

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    Market
    Place

    03

    Azacitidine

    JDMF

    Duphat
    Not Confirmed
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    Azacitidine

    India
    arrow
    Duphat
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    Registration Number : 303MF10033

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India

    Initial Date of Registration : 2021-02-16

    Latest Date of Registration : 2021-11-02

    blank

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    Market
    Place

    04

    Bicalutamide

    JDMF

    Duphat
    Not Confirmed
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    Bicalutamide

    India
    arrow
    Duphat
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    Registration Number : 225MF10084

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2013-04-23

    Latest Date of Registration : 2013-04-23

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    Market
    Place

    05

    Busulfan

    JDMF

    Duphat
    Not Confirmed
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    Busulfan

    India
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    Registration Number : 230MF10027

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India

    Initial Date of Registration : 2018-02-15

    Latest Date of Registration : 2018-02-15

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    Market
    Place

    06

    Capecitabine

    JDMF

    Duphat
    Not Confirmed
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    Capecitabine

    India
    arrow
    Duphat
    Not Confirmed
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    • WHO-GMP
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    Shilpa Medicare

    Registration Number : 229MF10131

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2017-07-19

    Latest Date of Registration : 2017-07-19

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    Market
    Place

    07

    Gemcitabine hydrochloride

    JDMF

    Duphat
    Not Confirmed
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    Gemcitabine hydrochloride

    India
    arrow
    Duphat
    Not Confirmed
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    • WHO-GMP
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    Shilpa Medicare

    Registration Number : 221MF10017

    Registrant's Address : 10/80, RAJENDRA GUNJ, RAICHUR-584 102, INDIA

    Initial Date of Registration : 2009-01-13

    Latest Date of Registration : 2014-11-17

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    Market
    Place

    08

    Letrozole

    JDMF

    Duphat
    Not Confirmed
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    Letrozole

    India
    arrow
    Duphat
    Not Confirmed
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    • WHO-GMP
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    Shilpa Medicare

    Registration Number : 226MF10029

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2014-02-05

    Latest Date of Registration : 2015-04-21

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    Market
    Place

    09

    Temozolomide

    JDMF

    Duphat
    Not Confirmed
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    Temozolomide

    India
    arrow
    Duphat
    Not Confirmed
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    Shilpa Medicare

    Registration Number : 228MF10125

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2016-07-12

    Latest Date of Registration : 2023-02-15

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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    EU WC

    read-more
    read-more

    01

    Acebrophylline (IH)

    India
    Duphat
    Not Confirmed
    arrow

    02

    Ambroxol Hydrochloride (Ph. ...

    India
    Duphat
    Not Confirmed
    arrow

    03

    Anastrozole USP/EP

    India
    Duphat
    Not Confirmed
    arrow

    04

    Axitinib IH

    India
    Duphat
    Not Confirmed
    arrow

    05

    Azacitidine IH

    India
    Duphat
    Not Confirmed
    arrow

    06

    Bendamustine HCI

    India
    Duphat
    Not Confirmed
    arrow

    07

    Bicalutamide (IH)

    India
    Duphat
    Not Confirmed
    arrow

    08

    Bortezomib (IH)

    India
    Duphat
    Not Confirmed
    arrow

    09

    Busulfan (Ph.Eur/USP)

    India
    Duphat
    Not Confirmed
    arrow

    10

    Cabazitaxel IH

    India
    Duphat
    Not Confirmed
    arrow
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    Contact Shilpa Medicare and get a quotation

    Shilpa Medicare is a supplier offers 74 products (APIs, Excipients or Intermediates).

    Find a price of Busulfan bulk with DMF, CEP, JDMF offered by Shilpa Medicare

    Find a price of Capecitabine bulk with DMF, CEP, JDMF offered by Shilpa Medicare

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    Find a price of Letrozole bulk with DMF, CEP, JDMF offered by Shilpa Medicare

    Find a price of Temozolomide bulk with DMF, CEP, JDMF offered by Shilpa Medicare

    Find a price of Ambroxol Hydrochloride bulk with CEP, JDMF offered by Shilpa Medicare

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    Find a price of Bicalutamide bulk with DMF, JDMF offered by Shilpa Medicare

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    Find a price of Imatinib Mesylate bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Irinotecan Hydrochloride bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Nifedipine bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Oxaliplatin bulk with DMF, CEP offered by Shilpa Medicare

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    Find a price of Clofarabine bulk with DMF offered by Shilpa Medicare

    Find a price of Decitabine bulk with DMF offered by Shilpa Medicare

    Find a price of Dimethyl Fumarate bulk with DMF offered by Shilpa Medicare

    Find a price of Enzalutamide bulk with DMF offered by Shilpa Medicare

    Find a price of Erlotinib Hydrochloride bulk with DMF offered by Shilpa Medicare

    Find a price of Imatinib Mesylate bulk with DMF offered by Shilpa Medicare

    Find a price of Lenalidomide bulk with DMF offered by Shilpa Medicare

    Find a price of Melphalan Hydrochloride bulk with DMF offered by Shilpa Medicare

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    Find a price of Praziquantel bulk with CEP offered by Shilpa Medicare

    Find a price of Prucalopride Succinate bulk with DMF offered by Shilpa Medicare

    Find a price of Sunitinib bulk with DMF offered by Shilpa Medicare

    Find a price of Anastrozole bulk with DMF offered by Shilpa Medicare

    Find a price of CAS 284461-73-0 bulk with CEP offered by Shilpa Medicare

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