Business Operations



    尊龙凯时AG(中国区)官方网站

    01
    R&D System
    02
    Manufacturing Facilties
    03
    Quality System

    The company now has more than 14,000 square metres of research use area and 100 million yuan of investment in research instruments and equipment. The company continues to increase R&D investment, R&D investment of 276 million yuan in 2023, accounting for 10.92% of revenue. The R&D team consists of nearly 500 people, of which more than 100 have master's and doctoral degrees. The main R&D direction involves blood pressure-lowering, blood sugar-lowering, lipid-lowering, anti-coagulation, anti-asthma, anti-virus, anti-tumour, anti-heart failure, anti-epileptic, gout, anti-prostate hyperplasia and so on. Our core technologies include Grignard reaction technology, diazotisation technology, asymmetric reduction technology and heterocyclic compound synthesis.

    At present, the company has 109 authorized patents, including 51 national authorized invention patents, 12 authorized invention patents from the United States, Europe, Japan, India and other countries, and 46 utility model patents: 32 invention patents are in the application stage, and the number of patent applications increases by 8-12 per year.

    2
    API R&D Centers
    3
    Formulation R&D Centers
    1
    CDMO R&D Center
    01
    R&D System
    02
    Manufacturing Facilties
    03
    Quality System

    Huangyan site

    Area (sqm):80000
    Types:APIs, Intermediates, Drugs, CDMO
    No. of Workshop:10
    GMP / Non-GMP:GMP
    Temp. Range (ºC):-20~150
    Max. Pressure (MPa):0.4
    Reactor Quantity:238
    Reaction Vol. (L):3000~10000
    Total Reaction Vol. (L):1243000

    Linhai site

    Area (sqm):87000
    Types:APIs, Intermediates, CDMO
    No. of Workshop:14
    GMP / Non-GMP:GMP
    Temp. Range (ºC):-80~120
    Max. Pressure (MPa):0.4
    Reactor Quantity:398
    Reaction Vol. (L):100~10,000
    Total Reaction Vol. (L):1993300

    Jingsheng site

    Area (sqm):85500
    Types:APIs, Intermediates, CDMO
    No. of Workshop:12
    GMP / Non-GMP:GMP
    Temp. Range (ºC):-70~200
    Max. Pressure (MPa):7.4
    Reactor Quantity:180
    Reaction Vol. (L):100~10,000
    Total Reaction Vol. (L):1059500

    Binhai site

    Area (sqm):80000
    Types:Intermediates, CDMO
    No. of Workshop:10
    GMP / Non-GMP:GMP
    Temp. Range (ºC):-50~200
    Max. Pressure (MPa):1.5
    Reactor Quantity:301
    Reaction Vol. (L):1000~6300
    Total Reaction Vol. (L):1200000

    Changyi site

    Area (sqm):250000
    Types:APIs, Intermediates, CDMO
    No. of Workshop:30
    GMP / Non-GMP:GMP
    Temp. Range (ºC):-40~180
    Max. Pressure (MPa):2.6
    Reactor Quantity:163
    Reaction Vol. (L):1000~10000
    Total Reaction Vol. (L):1026900

    Nuode site

    Since 2018
    Drug Products
    No. of Workshop:30
    First formulation, Irbesartan tablets for the Chinese market
    Current Capacity is 5.5 billion pieces
    Annual production capacity of 20 billion pieces + 250 million injections available in 2024
    6

    Production
    sites

    1

    Continuous large-scale
    production line

    2

    Multi-functional flexible
    production workshops

    3

    Key steps of products 
    using pipeline reaction

    1625

    Reaction
    equipments

    8Million

    Liter reaction
    equipment capacity

    01
    R&D System
    02
    Manufacturing Facilties
    03
    Quality System

    Quality - Trustworthy

    Tianyu has been serving as our clients' most trusted partner to improve operational productivity, create competitive advantages utilizing 4 manufacturing sites certified by many of the major regulatory authorities around the world ,including FDA,EDQM, PMDA, MFDS, TGA, and NMPA.


    Quality - Emphasis

    Tianyu has been on a mission to Supply High Quality Pharmaceutical Products to the World. In our QC laboratory,we utilize first-class analytical instruments like Aglient, Waters, SHlMADZU and more, Over 1200 sets of QC analytical equipments , including 20+ sets of Gc MSMS and LC MSMS instruments, with an investment of more than200 million RMB.



    Regulatory Agency Certification
    01
    R&D System
    02
    Manufacturing Facilties
    03
    Quality System
    Milestones Of Tianyu's Quality Construction History

    2023

    2023

    2018

    2015

    2014

    2013

    2023

    Linhai site passed USFDA inspection
    Jingsheng site passed USFDA inspection
    Binhai site passed PMDA inspection

    2023

    Linhai site passed joint EDQM/PMDA inspection
    Huangyan site passed PMDA and TGA joint inspection
    Huangyan site and Linhai site passed ANVISA inspection

    2018

    Huangyan site product Irbesartan was approved by TGA

    2015

    Huangyan site passed USFDA inspection

    2014

    Linhai site passed PMDA in Japan and COFEPRIS GMP inspection in Mexico.

    2013

    Huangyan site passed EDQM on-site inspection

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