menu
    • menu

    Company profile for CSPC Pharmaceutical Group

    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Virtual Booth

    Contact Supplier

    Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2024-10-07

    Virtual Booth

    Contact Supplier

    With Fermion, start the journey of your innovative API.

    Virtual Booth

    Contact Supplier

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

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2024-10-07

    Virtual Booth

    Contact Supplier

    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

    Update your Virtual Booth on PharmaCompass, ask us

    About

    CSPC Pharmaceutical Group Limited ("CSPC") (Stock code: 1093. HK) is a leading pharmaceutical group in China. It was established in 1997. Since the very beginning, CSPC has taken “All for better medicine, all for a healthier world” as its corporate mission. In all aspects of development, procurement, production, and distribution, they are committed to ensuring the health of people by creating high-quality, effective, relia...
    CSPC Pharmaceutical Group Limited ("CSPC") (Stock code: 1093. HK) is a leading pharmaceutical group in China. It was established in 1997. Since the very beginning, CSPC has taken “All for better medicine, all for a healthier world” as its corporate mission. In all aspects of development, procurement, production, and distribution, they are committed to ensuring the health of people by creating high-quality, effective, reliable, and innovative drugs that meet the needs of society.

    List your booth number for exhibitions, ask us

    CONTACT DETAILS

    Click the arrow to open the dropdown
    Contact SupplierContact
    Google MapGoogle Map
    Full View ScreenFull View Screen
    CSPC Pharmaceutical GroupChina Flag
    Country
    Country
    China
    Address
    Address
    No.896 Zhongshan East Road,Shijiazhuang, Hebei Province,PRC 050035
    Telephone
    Telephone
    +86 31187037015
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://en.e-cspc.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/cspcpharmaceuticalgroup/
    youtube
    YouTube
    Twitter
    Twitter

    Upload your Marketing & Sales content on your company Virtual Booth, click HERE.

    Events

    Webinars & Exhibitions

    Request a meetingRequest a meeting
    Full Screen ViewFull Screen View
    Default Event

    DCAT Week

    Not Confirmed

    envelop Contact Supplier

    DCAT Week

    Post an Enquiry

    Meeting

    Digital content

    Create Content with PharmaCompass, ask us

    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: 303

    subscribeSubscribe

    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
    Share info Share

    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 11518

    https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

    #PharmaFlow by PHARMACOMPASS
    21 Nov 2024
    Share Share

    NEWS #PharmaBuzz

    read-more
    read-more
    AstraZeneca Puts $2B On The Line for Preclinical Heart Disease Drug
    AstraZeneca Puts $2B On The Line for Preclinical Heart Disease Drug

    08 Oct 2024

    // BIOSPACE

    https://www.biospace.com/business/astrazeneca-puts-2b-on-the-line-for-preclinical-heart-disease-drug

    BIOSPACE
    08 Oct 2024
    Share Share
    China approves CSPC Pharma's RSV vaccine for clinical trials
    China approves CSPC Pharma's RSV vaccine for clinical trials

    12 Jul 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/china-approves-cspc-pharmas-rsv-vaccine-clinical-trials-2024-07-12/

    REUTERS
    12 Jul 2024
    Share Share
    Novo Nordisk braces for generic challenge to Ozempic, Wegovy in China
    Novo Nordisk braces for generic challenge to Ozempic, Wegovy in China

    06 Jun 2024

    // Andrew Silver REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-braces-generic-challenge-ozempic-wegovy-china-2024-06-05/

    Andrew Silver REUTERS
    06 Jun 2024
    Share Share
    Voluntary Announcement Olaparib Tablets Obtains Drug Registration Approval
    Voluntary Announcement Olaparib Tablets Obtains Drug Registration Approval

    03 Jun 2024

    // PRESS RELEASE

    https://doc.irasia.com/listco/hk/cspc/announcement/a240603.pdf

    PRESS RELEASE
    03 Jun 2024
    Share Share
    China's drugmakers can't sell mRNA shots but haven't quit yet
    China's drugmakers can't sell mRNA shots but haven't quit yet

    19 Apr 2024

    // Andrew Silver REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/who-says-wider-alert-contaminated-jj-cough-syrup-likely-2024-04-19/

    Andrew Silver REUTERS
    19 Apr 2024
    Share Share
    China's CSPC Pharma partners with Pfizer for oral COVID treatment
    China's CSPC Pharma partners with Pfizer for oral COVID treatment

    29 Jun 2023

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/chinas-cspc-pharma-partners-with-pfizer-covid-oral-treatment-2023-06-29/

    REUTERS
    29 Jun 2023
    Share Share

    USDMF

    read-more
    read-more

    01

    6 Apa (6-amino-penicillic Acid)

    China
    Antibody Engineering
    Not Confirmed
    arrow

    02

    6-amino-penicillanic Acid (by Direct...

    China
    Antibody Engineering
    Not Confirmed
    arrow

    03

    7-aminocephalosporanic Acid

    China
    Antibody Engineering
    Not Confirmed
    arrow

    04

    7-aminocephalosporanic Acid 7-aca

    China
    Antibody Engineering
    Not Confirmed
    arrow

    05

    Acarbose

    China
    Antibody Engineering
    Not Confirmed
    arrow

    06

    Acarbose

    China
    Antibody Engineering
    Not Confirmed
    arrow

    07

    Alendronate Sodium Usp 28

    China
    Antibody Engineering
    Not Confirmed
    arrow

    08

    Amoxicillin

    China
    Antibody Engineering
    Not Confirmed
    arrow

    09

    Ampicillin Trihydrate

    China
    Antibody Engineering
    Not Confirmed
    arrow

    10

    Ascorbic Acid (vitamin C)

    China
    Antibody Engineering
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
    click full view
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Excipients

    Click here to find the perfect excipient manufacturers by their capabilities

    Inspections and registrations

    Upload your audits for free, ask us

    ABOUT THIS PAGE

    Contact CSPC Pharmaceutical Group Limited and get a quotation

    CSPC Pharmaceutical Group Limited is a supplier offers 57 products (APIs, Excipients or Intermediates).

    Find a price of Acarbose bulk with DMF, CEP, JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Ascorbic Acid bulk with DMF, CEP, JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Hydroxocobalamin Acetate bulk with DMF, CEP, JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Indomethacin bulk with DMF, CEP, JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Vitamin B12 bulk with CEP, JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Cobamamide bulk with DMF, JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Methylcobalamin bulk with DMF, JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Sodium Ascorbate bulk with DMF, CEP offered by CSPC Pharmaceutical Group Limited

    Find a price of Azithromycin bulk with JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Cefazolin Sodium bulk with JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Glucose bulk with JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Tramadol Hydrochloride bulk with CEP offered by CSPC Pharmaceutical Group Limited

    Find a price of Vitamin B12 bulk with DMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Acarbose bulk with DMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Alendronate Sodium bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Amoxicillin Trihydrate bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Ampicillin Sodium bulk with JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Ampicillin Trihydrate bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Azathramycin bulk with DMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Azithromycin bulk with DMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Azithromycin Dihydrate bulk with CEP offered by CSPC Pharmaceutical Group Limited

    Find a price of Cefotaxime bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Cobamamide bulk with JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Indomethacin bulk with JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Meropenem bulk with JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Methylcobalamin bulk with JDMF offered by CSPC Pharmaceutical Group Limited

    Find a price of Tramadol Hydrochloride bulk with DMF offered by CSPC Pharmaceutical Group Limited

    Find a price of 6-Aminopenicillanic Acid bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of 7-Amino Cephalosporanic Acid bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Cefixime bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Ceftriaxone bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Penicillin G Potassium bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Ranitidine Hydrochloride bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Aminophylline bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Azlocillin Sodium bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Benzathine Penicillin G bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Benzylpenicillin Sodium bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Biapenem bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Caffeine bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Calcium Ascorbate bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Deacetyl-7-Aminocephalosporanic Acid bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Dyphylline bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Ertapenem Sodium bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Hydroxocobalamin bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Hydroxocobalamin Hydrochloride bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Mezlocillin bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Nafcillin Sodium bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Penicillin G Benzathine bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Penicillin G Procaine bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Pentoxifylline bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Piperacillin Sodium bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Sodium Carbonate bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Sulbactam bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Sulbactam Sodium bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Tazobactam Sodium bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Theobromine bulk offered by CSPC Pharmaceutical Group Limited

    Find a price of Theophylline bulk offered by CSPC Pharmaceutical Group Limited

    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search