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    About

    Jiangsu Hengrui Pharmaceuticals Co., Ltd. is a global pharmaceutical company engaged in the development and commercialization of innovative and high-quality drugs, focusing on the research and development of new drugs in the fields of anti-tumor, surgical drugs, autoimmune diseases, metabolic diseases, and cardiovascular diseases. Innovation is the core development strategy. Hengrui has 12 innovative products and 1 cooperative...
    Jiangsu Hengrui Pharmaceuticals Co., Ltd. is a global pharmaceutical company engaged in the development and commercialization of innovative and high-quality drugs, focusing on the research and development of new drugs in the fields of anti-tumor, surgical drugs, autoimmune diseases, metabolic diseases, and cardiovascular diseases. Innovation is the core development strategy. Hengrui has 12 innovative products and 1 cooperative innovative product marketed, more than 60 innovative candidates in the R&D stage, and more than 260 trials under clinical development around the world.

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    Jiangsu Hengrui MedicineChina Flag
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    China
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    No.7 Kunlunshan Road, Lianyungang Eco & Tech Development Zone, Lianyungang, Ji...
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    +86 518 81220983
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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: 5052

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

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    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

    FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

    In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 
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    Impressions: 1052

    https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies

    #PharmaFlow by PHARMACOMPASS
    30 Jan 2025
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    NEWS #PharmaBuzz

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    Hengrui & Kailera Report Positive Phase 2 Obesity Data For HRS9531
    Hengrui & Kailera Report Positive Phase 2 Obesity Data For HRS9531

    13 Jan 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/01/13/3008465/0/en/Jiangsu-Hengrui-Pharmaceuticals-and-Kailera-Therapeutics-Report-Positive-Topline-Data-from-8-mg-Dose-of-Phase-2-Obesity-Trial-of-GLP-1-GIP-Receptor-Dual-Agonist-HRS9531.html

    GLOBENEWSWIRE
    13 Jan 2025
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    IDEAYA snags second ADC in tie-up with Hengrui worth $1B
    IDEAYA snags second ADC in tie-up with Hengrui worth $1B

    30 Dec 2024

    // PRESS RELEASE

    https://ir.ideayabio.com/2024-12-29-IDEAYA-Biosciences-Enters-Exclusive-License-with-Hengrui-Pharma-for-SHR-4849,-a-Novel-Phase-1-DLL3-Topo-I-Payload-ADC-Targeting-SCLC-and-NET-Solid-Tumors

    PRESS RELEASE
    30 Dec 2024
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    Jiangsu Hengrui Pharma Receives FDA Warning Letter
    Jiangsu Hengrui Pharma Receives FDA Warning Letter

    16 Jul 2024

    // FDA

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jiangsu-hengrui-pharmaceuticals-co-ltd-679790-07112024

    FDA
    16 Jul 2024
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    Hengrui Pharma's Generic Bupivacaine liposome Receives Approval in US
    Hengrui Pharma's Generic Bupivacaine liposome Receives Approval in US

    02 Jul 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214348

    FDA
    02 Jul 2024
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    FDA hands Chinese drug Mfg Form 483 noting employees destroyed documents 
    FDA hands Chinese drug Mfg Form 483 noting employees destroyed documents 

    05 Jun 2024

    // Anna Brown ENDPTS

    https://endpts.com/fda-hands-chinese-drug-manufacturer-a-form-483-noting-employees-destroyed-documents/

    Anna Brown ENDPTS
    05 Jun 2024
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    FDA Issues Form 483 to Jiangsu Hengrui Pharmceuticals
    FDA Issues Form 483 to Jiangsu Hengrui Pharmceuticals

    04 Jun 2024

    // FDA

    https://www.fda.gov/media/179134/download?attachment

    FDA
    04 Jun 2024
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    ALL APIs

    read-moreClick the button for full data set
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    01

    Oxaliplatin

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

    VMX
    Not Confirmed
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    Oxaliplatin

    China

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

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    VMX
    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 : 2013-06-03

    Pay. Date : 2012-12-24

    DMF Number : 20665

    Submission : 2007-07-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2005-079 - Rev 04

    Issue Date : 2024-07-30

    Type : Chemical

    Substance Number : 2017

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10210

    Registrant's Address : No. 7, Kunlunshan Road, Economic and Technological Development Zone, Lianyungang, Jiangsu Province, P. R. China

    Initial Date of Registration : 2010-08-04

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 57884-0017

    Start Marketing Date : 2007-05-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (0.5kg/.5kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samyang Holdings Co., Ltd.

    Registration Date : 2017-02-28

    Registration Number : 20150413-197-I-440-11(A)

    Manufacturer Name : Jiangsu Hengrui Pharmaceuticals Co., Ltd.

    Manufacturer Address : No. 22, Jinqiao Road, Dapu Industrial Park, Economic and Technological Development Zone, Lianyungang, Jiangsu Province, PR China, 222002

     VMF Others AUDIT
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    02

    Letrozole

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

    VMX
    Not Confirmed
    arrow

    Letrozole

    China

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

    arrow
    VMX
    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 : 23831

    Submission : 2010-05-24

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-270 - Rev 05

    Issue Date : 2024-07-31

    Type : Chemical

    Substance Number : 2334

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10030

    Registrant's Address : No. 7, Kunlunshan Road, Economic and Technological Development Zone, Lianyungang, Jiangsu Province, P. R. China

    Initial Date of Registration : 2014-02-05

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 57884-0011

    Start Marketing Date : 2012-05-07

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kwangdong Pharmaceutical Co., Ltd.

    Registration Date : 2019-11-28

    Registration Number : 20191001-209-J-211(1)

    Manufacturer Name : Jiangsu Hengrui Pharmaceuticals Co., Ltd

    Manufacturer Address : Jinqiao Road, Dapu Industrial Park, Economic & Technological Development Zone China

     VMF Others AUDIT
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    03

    Sevoflurane

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

    VMX
    Not Confirmed
    arrow

    Sevoflurane

    China

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

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    VMX
    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 : 24903

    Submission : 2011-04-29

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-297 - Rev 03

    Issue Date : 2024-08-21

    Type : Chemical

    Substance Number : 2269

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10009

    Registrant's Address : No. 7, Kunlunshan Road, Economic and Technological Development Zone, Lianyungang, Jiangsu Province, P. R. China

    Initial Date of Registration : 2019-01-10

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Toru Corporation

    Registration Date : 2021-01-21

    Registration Number : 20210121-211-J-647

    Manufacturer Name : Jiangsu Hengrui Pharmaceuticals Co., Ltd.

    Manufacturer Address : Jinqiao Road, Dapu Industrial Park, Economic & Technological Development Zone Lianyungang, Jiangsu China

     VMF Others AUDIT
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    04

    Dexmedetomidine Hydrochloride

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

    VMX
    Not Confirmed
    arrow

    Dexmedetomidine Hydrochloride

    China

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-16

    Pay. Date : 2013-04-29

    DMF Number : 26377

    Submission : 2012-09-04

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF10029

    Registrant's Address : No. 7, Kunlunshan Road, Economic and Technological Development Zone, Lianyungang, Jiangsu Province, P. R. China

    Initial Date of Registration : 2016-02-02

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 57884-0024

    Start Marketing Date : 2012-09-04

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (0.4kg/.4kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Toru Corporation

    Registration Date : 2021-01-13

    Registration Number : No. 6580-24-ND(3)

    Manufacturer Name : Jiangsu Hengrui Pharmaceuticals Co., Ltd

    Manufacturer Address : No. 22, Jinqiao Road, Dapu Industrial Park, Economic & Technological Development Zone, Lianyungang, Jiangsu Province, China

     VMF Others AUDIT
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    05

    Etoposide

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

    VMX
    Not Confirmed
    arrow

    Etoposide

    China

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

    arrow
    VMX
    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 : 2015-05-07

    Pay. Date : 2015-04-15

    DMF Number : 8647

    Submission : 1990-07-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2008-037 - Rev 05

    Issue Date : 2023-10-09

    Type : Chemical

    Substance Number : 823

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 57884-0008

    Start Marketing Date : 2010-08-25

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    #PipelineProspector

    Market
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    06

    Irinotecan Hydrochloride

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

    VMX
    Not Confirmed
    arrow

    Irinotecan Hydrochloride

    China

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20739

    Submission : 2007-08-01

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 226MF10183

    Registrant's Address : No. 7, Kunlunshan Road, Economic and Technological Development Zone, Lianyungang, Jiangsu Province, P. R. China

    Initial Date of Registration : 2014-09-30

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 57884-0009

    Start Marketing Date : 2007-08-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Otran Pharm Korea Co., Ltd.

    Registration Date : 2022-04-08

    Registration Number : 20220408-210-J-1262

    Manufacturer Name : Jiangsu Hengrui Pharmaceuticals Co., Ltd

    Manufacturer Address : Jinqiao Road, Dapu Industrial Park, Economic & Technological Development Zone China

     VMF Others AUDIT
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    07

    Ifosfamide

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

    VMX
    Not Confirmed
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    Ifosfamide

    China

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

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    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-09-04

    Pay. Date : 2015-08-18

    DMF Number : 11290

    Submission : 1995-01-11

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2013-026 - Rev 00

    Issue Date : 2019-09-04

    Type : Chemical

    Substance Number : 1529

    Status : Withdrawn by Holder

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 57884-0006

    Start Marketing Date : 2010-08-25

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    08

    Cisatracurium Besylate

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

    VMX
    Not Confirmed
    arrow

    Cisatracurium Besylate

    China

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-07-27

    Pay. Date : 2015-07-17

    DMF Number : 25511

    Submission : 2011-11-17

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 57884-0018

    Start Marketing Date : 2011-11-17

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (2kg/2kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Cyclophosphamide

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

    VMX
    Not Confirmed
    arrow

    Cyclophosphamide

    China

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26041

    Submission : 2012-05-11

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 57884-0022

    Start Marketing Date : 2012-05-11

    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

    Docetaxel

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

    VMX
    Not Confirmed
    arrow

    Docetaxel

    China

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-12

    Pay. Date : 2012-11-30

    DMF Number : 24175

    Submission : 2010-09-13

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 57884-0014

    Start Marketing Date : 2010-09-13

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    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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    Inspections and registrations

    Upload your audits for free, ask us

    FDA

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    read-more

    01

    FDA Audited

    USA
    VMX
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    VMX
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-07-13

    Jiangsu Hengrui Medicine

    City : Lianyungang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-07-13

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    02

    FDA Audited

    USA
    VMX
    Not Confirmed
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    FDA Audited

    USA
    arrow
    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-07-26

    Jiangsu Hengrui Medicine

    City : Lianyuangang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-07-26

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    03

    FDA Audited

    USA
    VMX
    Not Confirmed
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    FDA Audited

    USA
    arrow
    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-08-01

    Jiangsu Hengrui Medicine

    City : Lianyungang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-08-01

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    04

    FDA Audited

    USA
    VMX
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-08-20

    Jiangsu Hengrui Medicine

    City : Lianyungang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-08-20

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    05

    FDA Audited

    USA
    VMX
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-09-10

    Jiangsu Hengrui Medicine

    City : Lianyungang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-09-10

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    06

    FDA Audited

    USA
    VMX
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-13

    Jiangsu Hengrui Medicine

    City : Lianyuangang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-13

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    07

    FDA Audited

    USA
    VMX
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-08-28

    Jiangsu Hengrui Medicine

    City : Lianyungang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-08-28

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    ABOUT THIS PAGE

    Contact Jiangsu Hengrui Pharmaceuticals and get a quotation

    Jiangsu Hengrui Pharmaceuticals is a supplier offers 35 products (APIs, Excipients or Intermediates).

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    Find a price of ER301 NON-STERILE DRUG SUBSTANCE INTERMEDIATE bulk with DMF offered by Jiangsu Hengrui Pharmaceuticals

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