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    Company profile for Polpharma

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    Polpharma's HP API facility is live!

    10 Oct 2024

    // PRESS RELEASE

    Rising Prevalence of Cancer and Its Impact on the HP API Market

    10 Oct 2024

    // PRESS RELEASE

    Addressing Nitrosamine Risks in Pharmaceutical Manufacturing

    10 Oct 2024

    // PRESS RELEASE

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    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

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    Pelplińska 19, 83-200 Starogard Gdański
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    +48 585631600
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    api@polpharma.com
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    INTERVIEW #SpeakPharma

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    “Polpharma has invested over €35 million in a new facility to handle HPAPIs”

    “Polpharma has invested over €35 million in a new facility to handle HPAPIs”

    Over the recent years, the market for contract development and manufacturing organizations (CDMOs) has been growing at a fast clip owing to a plethora of factors such as the rising demand for biologics, new trends towards personalized medicines and the need to bring new treatments to the market more quickly. This week, SpeakPharma interviews Dawid Ignatowicz, Head of Key Account Management, CDMO, Polpharma, to know how the Polish drugmaker is growing its CDMO business and some of the inherent advantages it enjoys in this landscape. Of late, there has been an increase in demand for drug substance development and cGMP manufacturing services. How is Polpharma gearing up to meet this demand? In fact, the number of drug developments has increased over the past few years.  This coupled with some lack of capacity in some major European CDMO’s, potentiates good opportunities for companies like Polpharma. Over the last few years, Polpharma has been growing its offer on the CDMO, either by adding new capabilities in research and development and in production or by increasing its manufacturing standards (compliance, EHS, etc.).  Our objective is to support our customers into the different phases of drug development, as such we have adapted our systems to be able to answer their requirements on the different stages – with the ultimate goal of providing a reliable, efficient, and cost-effective service to the customers.  What differentiates Polpharma from other CDMOs? Our major strengths can be referred as: good project management skills (we have a group of experienced people that help the customers), transparency (since the inception of a project we have developed a clear and transparent way of communicating flow with the customer so that we can have full visibility of their project in our site), an ability to listen to our customers (a rather simple requirement, but that seems difficult to find in the market), good process design (more delivery kilos of a product we want to establish a good efficient and cost-effective process) and flexibility (we understand that development projects could have changes on the timelines and the capability to adapt to those changes is critical). Besides the above, we have a positive track record of regulatory approvals coupled with experience and expertise in filing to the FDA. We have positive pre-approval inspection audits (PAIs) that reaffirm our robust quality management system. We are known for efficient management of changes and deviations — we are both open and collaborative and work alongside our clients. Tell us about the range of CDMO projects that Polpharma handles. Owing to our decades-long experience in drug substance development, regulatory filing, and commercial manufacturing, Polpharma can support customers at various phases — from clinical supplies, through validation and launch, up to regular commercial supplies. Manufacturing highly potent APIs comes with several challenges, especially with respect to toxicity and exposure. Are you observing more projects with high toxicity? In order to address the growing demand for the development and manufacture of highly active compounds, we have invested over €35 million in a new facility to handle HPAPIs that will include process and analytical R&D, small-scale cGMP manufacturing suites and quality control (QC) labs. This facility will allow us to handle compounds with an occupational exposure limit (OEL) value down to 10 ng/m3 (or OEB6, i.e. very high contamination).  

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    https://www.pharmacompass.com/speak-pharma/polpharma-has-invested-over-35mln-euros-in-a-completely-new-facility-to-handle-hpapis

    #SpeakPharma With Polpharma
    11 Sep 2023
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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    Corporate Presentation

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    GMP Certificate 2024

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      https://www.pharmacompass.com/pdf/party/content/polpharma-party-content-17294.pdf

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    High Potency API 2024

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    CDMO Brochure 2023

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    Ipochem Corporate Presentation

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    Ipochem Product List 2022

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    DATA COMPILATION #PharmaFlow

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    FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea

    FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea

    Biologics, or complex drugs that are derived from living organisms, have revolutionized treatment of various conditions such as cancer, autoimmune diseases, and chronic illnesses. In 2023, eight out of 10 of the world’s top-selling drugs were biologics, including Merck’s Keytruda, AbbVie’s Humira, and Sanofi’s Dupixent.Due to their high costs, accessibility of biologics has been a challenge. That’s why biosimilars, or game-changing copycats of biologics that provide highly similar yet more affordable alternatives to established biologics, are becoming popular.The first biosimilar — Sandoz’ Zarxio — was approved by the US Food and Drug Administration (FDA) in 2015. Its reference biologic was Amgen’s Neupogen (filgrastim).  Since then, the global market for biosimilars has been growing at an impressive pace — between 2015 and 2020, it grew at a whopping compounded annual growth rate (CAGR) of 78 percent, touching US$ 17.9 billion in size. It is expected to continue growing at a CAGR of 15 percent and reach a size of about US$ 75 billion by 2030.Major biosimilar players include Amgen, Sandoz, Samsung Bioepis, Pfizer, Biocon Biologics, Celltrion, Stada Arzneimittel, Accord Healthcare, Fresenius Kabi, Coherus Biosciences, Apotex, and Sanofi. The increasing demand for biosimilars has propelled growth in contract manufacturing. Some of the leading contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that manufacture biosimilars are Polpharma Biologics, Catalent, Pfizer CentreOne, Lonza, Boehringer Ingelheim BioXcellence, Thermo Fisher Scientific, WuXi Biologics, and FUJIFILM Diosynth Biotechnologies.Access the Interactive Dashboard for Biosimilar Developments (Free Excel)Amgen, Sandoz top list of ‘approved biosimilars’; FDA okays 8 copycats in H1 2024Over the recent years, regulatory agencies like the FDA and the European Medicines Agency (EMA) have established rigorous approval pathways for biosimilars.Since 2015,  FDA has approved 53 biosimilars, while the EMA has approved 86 biosimilars. Among the US, European and Canadian markets, Amgen and Sandoz are tied in the first place with 13 approved biosimilars each. Samsung Biologics has nine approved biosimilars, followed by Pfizer with eight and Biocon Biologics with seven. In the first half of this year, FDA set a record by approving eight biosimilars — the highest for H1 of any year. EMA has okayed six biosimilars so far in 2024.In 2023, five biosimilars were approved by the FDA with just one being okayed in the first half. The year marked the end of exclusivity for Humira after 20 years, in which it netted a total of US$ 200 billion in sales. AbbVie’s flagship autoimmune drug has a record 10 biosimilars.Johnson & Johnson’s Stelara also lost exclusivity in 2023 and as many as 11 drugmakers hope to bring its biosimilars to the market. Amgen’s Wezlana was the first biosimilar to Stelara, and it was approved as interchangeable by FDA in October last year.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) FDA approves first interchangeable biosimilar for Eylea, cuts regulatory feeDeveloping a biosimilar costs both money and time. According to Pfizer, developing a biosimilar can take five to nine years and cost over US$ 100 million, not including regulatory fees.In October 2023, FDA slashed its fees with the program fee at US$ 177,397, down from US$ 304,162. The application fees for products that require clinical data has been set at US$ 1,018,753, down from US$ 1,746,745. The application fee for products that don’t require clinical data has been set lower — at US$ 509,377 —  down from US$ 873,373 set earlier. This reduction in application fee has propelled demand for contract manufacturing of biosimilars.There has also been a rise in approvals of interchangeable biosimilars this year. Interchangeable biosimilars meet additional requirements and may be substituted for its reference product by a pharmacist without consulting the prescriber. This year saw FDA approve the first interchangeable biosimilars for bone cancer drug denosumab (Prolia and Xgeva) in Jubbonti and Wyost as well as for eculizumab (Soliris) in Bkemv.In May, FDA approved the first interchangeable biosimilars for eye drug aflibercept (Eylea) in Opuviz and Yesafili. Other biosimilars approved in 2024 include Simlandi for adalimumab (Humira), Tyenne for tocilizumab (Actemra), Selarsdi for ustekinumab (Stelara), and Hercessi for trastuzumab (Herceptin).Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Merck’s Keytruda, BMS’ Opdivo, Novartis’ Cosentyx brace for biosimilar competitionHealthcare spending in the US is projected to rise from US$ 4.5 trillion in 2022 to US$ 6 trillion by 2027. While biologics involve just two percent of prescriptions, they account for 46 percent of all pharmaceutical spending. In 2022, US$ 252 billion was spent on biologics.Biosimilar-related savings in 2023 were estimated to be US$ 9.4 billion in the US and € 10 billion (US$ 10.68 billion) in Europe. With expensive and widely used drugs like AbbVie’s Humira, J&J’s Stelara, and Regeneron’s Eylea coming under competition, US savings are projected to reach US$ 181 billion through 2027. Between 2026 and 2032, about 39 blockbusters are set to lose exclusivity in the US and Europe. Merck’s Keytruda (pembrolizumab) was the world’s top-selling drug last year, generating US$ 25 billion in sales. Its patent is set to expire in 2028 with sales expected to drop 19 percent to US$ 27.4 billion in 2029 from US$ 33.7 billion the previous year. Samsung Bioepis and Amgen initiated phase 3 trials of pembrolizumab in April and May of this year, respectively.Opdivo (nivolumab), belonging to the same class of drugs, competes with Keytruda and is also set to lose patent protection in 2028. It hauled in US$ 10 billion in total global sales in 2023 for Bristol Myers Squibb. The key patents of Novartis’ Cosentyx (secukinumab) are set to expire between 2025 and 2026. Cosentyx saw sales of US$ 5 billion in 2023. Taizhou Mabtech Pharmaceutical and Bio-Thera Solutions are conducting phase 3 trials of secukinumab.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Our viewWith over 2 billion people worldwide unable to access life-saving medicines, biosimilars hold the key to healthcare accessibility. In 2023, a record 13 biosimilars were launched in the market — the highest for a single year. And this included nine much-anticipated biosimilars to AbbVie’s Humira.  In April this year, FDA announced a Biosimilars Action Plan to streamline the development of biosimilars. With a sharp focus on biosimilars, we expect more records to be broken in the near term. New launches of biosimilars to drugs like J&J’s Stelara, Regeneron’s Eylea and Merck’s Keytruda will surely help in creating new records.
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    https://www.pharmacompass.com/radio-compass-blog/fda-approves-record-eight-biosimilars-in-h1-2024-okays-first-interchangeable-biosimilars-for-eylea

    #PharmaFlow by PHARMACOMPASS
    27 Jun 2024
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    NEWS #PharmaBuzz

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    Polpharma's HP API facility is live!
    Polpharma's HP API facility is live!

    10 Oct 2024

    // PRESS RELEASE

    https://www.api.polpharma.com/articles/polpharmas-hp-api-facility-is-live

    PRESS RELEASE
    10 Oct 2024
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    Rising Prevalence of Cancer and Its Impact on the HP API Market
    Rising Prevalence of Cancer and Its Impact on the HP API Market

    10 Oct 2024

    // PRESS RELEASE

    https://www.api.polpharma.com/articles/rising-prevalence-of-cancer-and-its-impact-on-the-hp-api-market

    PRESS RELEASE
    10 Oct 2024
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    Addressing Nitrosamine Risks in Pharmaceutical Manufacturing
    Addressing Nitrosamine Risks in Pharmaceutical Manufacturing

    10 Oct 2024

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    https://www.api.polpharma.com/articles/addressing-nitrosamine-risks-in-pharmaceutical-manufacturing

    PRESS RELEASE
    10 Oct 2024
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    Polpharma acquires Ziołolek
    Polpharma acquires Ziołolek

    01 Oct 2024

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    https://polpharma.pl/en/polpharma-acquires-ziololek/

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    01 Oct 2024
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    Polpharma & MSN Lab Announce Strategic Distribution Partnership
    Polpharma & MSN Lab Announce Strategic Distribution Partnership

    23 Sep 2024

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    https://polpharma.pl/en/polpharma-and-msn-laboratories-announce-strategic-distribution-partnership/

    PRESS RELEASE
    23 Sep 2024
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    Polpharma’s strategic investment in HPAPI facility, the first of this kind in Poland
    Polpharma’s strategic investment in HPAPI facility, the first of this kind in Poland

    12 Sep 2024

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    https://www.api.polpharma.com/news/polpharmas-strategic-investment-in-hpapi-facility-the-first-of-this-kind-in-poland/

    PRESS RELEASE
    12 Sep 2024
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    USDMF

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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-15

    DMF Number : 10383

    Submission : 1993-07-30

    Status : Active

    Type : II

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-02-10

    Pay. Date : 2016-12-20

    DMF Number : 31166

    Submission : 2016-11-16

    Status : Active

    Type : II

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    Polpharma

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-04-07

    Pay. Date : 2016-12-20

    DMF Number : 31141

    Submission : 2016-11-09

    Status : Active

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    Polpharma

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-02-20

    Pay. Date : 2013-12-19

    DMF Number : 23314

    Submission : 2009-11-27

    Status : Active

    Type : II

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    Aripiprazole Lauroxil

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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    GDUFA

    DMF Review : Complete

    Rev. Date : 2018-12-10

    Pay. Date : 2018-08-21

    DMF Number : 31531

    Submission : 2018-08-16

    Status : Active

    Type : II

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    Aripiprazole Monohydrate

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    Polpharma

    GDUFA

    DMF Review : N/A

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    Pay. Date :

    DMF Number : 33204

    Submission : 2018-10-30

    Status : Active

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    07

    Avanafil

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    Polpharma

    GDUFA

    DMF Review : N/A

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    DMF Number : 29689

    Submission : 2015-08-20

    Status : Active

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    08

    Baclofen

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    Polpharma

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-08

    Pay. Date : 2012-12-11

    DMF Number : 18014

    Submission : 2005-01-20

    Status : Active

    Type : II

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    Brexpiprazole

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    GDUFA

    DMF Review : N/A

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    DMF Number : 32347

    Submission : 2017-12-21

    Status : Active

    Type : II

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    Carbamazepine

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    Polpharma

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-12-16

    Pay. Date : 2015-06-25

    DMF Number : 26266

    Submission : 2012-07-31

    Status : Active

    Type : II

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    LISTED APIs

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    Abemaciclib

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    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Pro...
    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
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    Abemaciclib

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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

    About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous deve...

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    Acenocoumarol

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    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Pro...
    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
    Polpharma CB

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    Acenocoumarol

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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

    About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous deve...

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    Acetazolamide

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    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Pro...
    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
    Polpharma CB

    03

    Acetazolamide

    Poland
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

    About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous deve...

    Polpharma CB

    Product
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    #Pipeline Prospector

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    Contact Supplier
    • FDA
    • EDQM
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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Alendronate Sodium

    Product
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    Stock Recap
    #PipelineProspector

    Market
    Place

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Pro...
    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
    Polpharma CB

    04

    Alendronate Sodium

    Poland
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

    About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous deve...

    Polpharma CB

    Product
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    Stock Recap
    #Pipeline Prospector

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    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Aniracetam

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Pro...
    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
    Polpharma CB

    05

    Aniracetam

    Poland
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

    About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous deve...

    Polpharma CB

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Antazoline HCl

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Pro...
    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
    Polpharma CB

    06

    Antazoline HCl

    Poland
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

    About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous deve...

    Polpharma CB

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    Contact Supplier
    • FDA
    • EDQM
    • fda
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    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Antazoline Mesylate

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Pro...
    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
    Polpharma CB

    07

    Antazoline Mesylate

    Poland
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

    About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous deve...

    Polpharma CB

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

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    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Antazoline Sulfate

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Pro...
    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
    Polpharma CB

    08

    Antazoline Sulfate

    Poland
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

    About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous deve...

    Polpharma CB

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

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    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Apixaban

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Pro...
    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
    Polpharma CB

    09

    Apixaban

    Poland
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

    About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous deve...

    Polpharma CB

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Apremilast

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Pro...
    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
    Polpharma CB

    10

    Apremilast

    Poland
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma

    Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

    About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous deve...

    Polpharma CB

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    Only 10 entries up to this point, click to access all click full view read-more
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    Drugs in Development

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    • Development Update
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    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma's Investigational Biosimilar Shows PK/PD Comparability To Entyvio® For IBD

    Details:

    PB016 (vedolizumab) is a humanized monoclonal antibody that specifically binds to the α4β7 integrin & blocks the interaction of α4β7 integrin. It is being evaluated for Ulcerative Colitis.


    Lead Product(s): Vedolizumab

    Therapeutic Area: Gastroenterology Brand Name: PB016

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 21, 2024

    Polpharma CB

    01

    Polpharma

    Poland
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Lead Product(s) : Vedolizumab

    Therapeutic Area : Gastroenterology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Polpharma's Investigational Biosimilar Shows PK/PD Comparability To Entyvio® For IBD

    Details : PB016 (vedolizumab) is a humanized monoclonal antibody that specifically binds to the α4β7 integrin & blocks the interaction of α4β7 integrin. It is being evaluated for Ulcerative Colitis.

    Brand Name : PB016

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    February 21, 2024

    Polpharma CB

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Sandoz Receives FDA Approval for Tyruko (natalizumab-sztn), First and Only FDA-Approved Biosimilar for Relapsing Forms of Multiple Sclerosis

    Details:

    Tyruko (natalizumab-sztn) biosimilar is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.


    Lead Product(s): Natalizumab-sztn

    Therapeutic Area: Neurology Brand Name: Tyruko

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Sandoz B2B

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 25, 2023

    Polpharma CB

    02

    Polpharma

    Poland
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Lead Product(s) : Natalizumab-sztn

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Recipient : Sandoz B2B

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz Receives FDA Approval for Tyruko (natalizumab-sztn), First and Only FDA-Approved Biosimilar...

    Details : Tyruko (natalizumab-sztn) biosimilar is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple scleros...

    Brand Name : Tyruko

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    August 25, 2023

    Polpharma CB

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Deals
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Ryvu Therapeutics Enters into Two Agreements with Zakłady Farmaceutyczne Polpharma S.A. in the Area of RVU120 Active Substance (API) Production for Pha...

    Details:

    RVU120 is a selective, first-in-class dual CDK8/CDK19 kinase inhibitor that has shown signs of clinical activity in treated patients, as well as efficacy in numerous in vitro and in vivo models of hematologic malignancies and solid tumors.


    Lead Product(s): RVU120

    Therapeutic Area: Oncology Brand Name: RVU120

    Study Phase: PreclinicalProduct Type: Small molecule

    Sponsor: Ryvu Therapeutics

    Deal Size: $1.0 million Upfront Cash: Undisclosed

    Deal Type: Agreement July 06, 2023

    Polpharma CB

    03

    Polpharma

    Poland
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Lead Product(s) : RVU120

    Therapeutic Area : Oncology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Ryvu Therapeutics

    Deal Size : $1.0 million

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Ryvu Therapeutics Enters into Two Agreements with Zakłady Farmaceutyczne Polpharma S.A. in the Ar...

    Details : RVU120 is a selective, first-in-class dual CDK8/CDK19 kinase inhibitor that has shown signs of clinical activity in treated patients, as well as efficacy in numerous in vitro and in vivo models of hematologic malignancies and solid tumors.

    Brand Name : RVU120

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    July 06, 2023

    Polpharma CB

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    U.S. Food and Drug Administration (FDA) Approves FYB201/CIMERLITM* (ranibizumab-eqrn), The First and Only Biosimilar Interchangeable with Lucentis®**

    Details:

    CIMERLI (Ranibizumab) is the first and only interchangeable biosimilar with an exclusivity for 12 months after market launch that is indicated for the treatment of all five Lucentis® indications and, as such, is a new medical option for patients with serious retinal diseases.


    Lead Product(s): Ranibizumab

    Therapeutic Area: Ophthalmology Brand Name: Cimerli

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 03, 2022

    Polpharma CB

    04

    Polpharma

    Poland
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Lead Product(s) : Ranibizumab

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    U.S. Food and Drug Administration (FDA) Approves FYB201/CIMERLITM* (ranibizumab-eqrn), The First a...

    Details : CIMERLI (Ranibizumab) is the first and only interchangeable biosimilar with an exclusivity for 12 months after market launch that is indicated for the treatment of all five Lucentis® indications and, as such, is a new medical option for patients with se...

    Brand Name : Cimerli

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    August 03, 2022

    Polpharma CB

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    FDA Approves Coherus’ CIMERLI™ (ranibizumab-eqrn) as the First and Only Interchangeable Biosimilar to Lucentis® for All Five Indications, with 12 M...

    Details:

    The COLUMBUS-AMD study, published in highly-regarded medical journal Ophthalmology, was the head-to-head study where CIMERLI (ranibizumab) met its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week 8 as compared to reference ranibizumab.


    Lead Product(s): Ranibizumab

    Therapeutic Area: Ophthalmology Brand Name: Cimerli

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Coherus Biosciences

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 02, 2022

    Polpharma CB

    05

    Polpharma

    Poland
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Lead Product(s) : Ranibizumab

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Recipient : Coherus Biosciences

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA Approves Coherus’ CIMERLI™ (ranibizumab-eqrn) as the First and Only Interchangeable Biosim...

    Details : The COLUMBUS-AMD study, published in highly-regarded medical journal Ophthalmology, was the head-to-head study where CIMERLI (ranibizumab) met its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week 8 as compared to re...

    Brand Name : Cimerli

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    August 02, 2022

    Polpharma CB

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma Biologics Announces FDA File Acceptance For Review Of Natalizumab, First Proposed Biosimilar To Tysabri®

    Details:

    Tysabri® (natalizumab) - a monotherapy for adult patients with relapsing-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.


    Lead Product(s): Natalizumab

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 29, 2022

    Polpharma CB

    06

    Polpharma

    Poland
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Lead Product(s) : Natalizumab

    Therapeutic Area : Neurology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Polpharma Biologics Announces FDA File Acceptance For Review Of Natalizumab, First Proposed Biosim...

    Details : Tysabri® (natalizumab) - a monotherapy for adult patients with relapsing-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.

    Brand Name : Undisclosed

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 29, 2022

    Polpharma CB

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    • Development Update
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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Applications for Proposed First-of-a-kind Multiple Sclerosis Biosimilar Natalizumab Accepted by US FDA and EMA

    Details:

    PB006 (natalizumab) is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.


    Lead Product(s): Natalizumab

    Therapeutic Area: Neurology Brand Name: PB006

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Sandoz B2B

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 25, 2022

    Polpharma CB

    07

    Polpharma

    Poland
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Lead Product(s) : Natalizumab

    Therapeutic Area : Neurology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Sandoz B2B

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Applications for Proposed First-of-a-kind Multiple Sclerosis Biosimilar Natalizumab Accepted by US...

    Details : PB006 (natalizumab) is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumul...

    Brand Name : PB006

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 25, 2022

    Polpharma CB

    Stock Recap
    #PipelineProspector

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    Virtual Booth

    • Deals
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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma Partners with Pikralida Biopharmaceutical Start-Up

    Details:

    The partnership involves manufacturing of the drug substance of the clinical candidate PKL-021, needed to support the preclinical research program and the production of an investigational medicinal product for the phase one clinical trial.


    Lead Product(s): PKL-021

    Therapeutic Area: Neurology Brand Name: PKL-021

    Study Phase: PreclinicalProduct Type: Small molecule

    Sponsor: Pikralida biopharmaceutical

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership July 19, 2022

    Polpharma CB

    08

    Polpharma

    Poland
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Lead Product(s) : PKL-021

    Therapeutic Area : Neurology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Pikralida biopharmaceutical

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Polpharma Partners with Pikralida Biopharmaceutical Start-Up

    Details : The partnership involves manufacturing of the drug substance of the clinical candidate PKL-021, needed to support the preclinical research program and the production of an investigational medicinal product for the phase one clinical trial.

    Brand Name : PKL-021

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    July 19, 2022

    Polpharma CB

    Stock Recap
    #PipelineProspector

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    #PharmaFlow

    Virtual Booth

    • Development Update
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Polpharma Biologics Announces EMA Acceptance of Marketing Authorization Application for Proposed Biosimilar Natalizumab

    Details:

    Natalizumab a proposed biosimilar to Tysabri is a humanised monoclonal antibody that blocks integrin α4β1-mediated leukocyte migration from blood vessels to the brain and prevent highly active relapsing-remitting multiple sclerosis.


    Lead Product(s): Natalizumab

    Therapeutic Area: Neurology Brand Name: PB006

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Sandoz B2B

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 14, 2022

    Polpharma CB

    09

    Polpharma

    Poland
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Lead Product(s) : Natalizumab

    Therapeutic Area : Neurology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Sandoz B2B

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Polpharma Biologics Announces EMA Acceptance of Marketing Authorization Application for Proposed B...

    Details : Natalizumab a proposed biosimilar to Tysabri is a humanised monoclonal antibody that blocks integrin α4β1-mediated leukocyte migration from blood vessels to the brain and prevent highly active relapsing-remitting multiple sclerosis.

    Brand Name : PB006

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 14, 2022

    Polpharma CB

    Stock Recap
    #PipelineProspector

    Data Compilation
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    Virtual Booth

    • Development Update
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    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    MHRA’s Authorization for BIOEQ’s Biosimilar in the United Kingdom

    Details:

    CIMERLI™ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI™. Hypersensitivity reactions may manifest as severe intraocular inflammation


    Lead Product(s): Ranibizumab

    Therapeutic Area: Ophthalmology Brand Name: Cimerli

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 06, 2022

    Polpharma CB

    10

    Polpharma

    Poland
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

    Lead Product(s) : Ranibizumab

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    MHRA’s Authorization for BIOEQ’s Biosimilar in the United Kingdom

    Details : CIMERLI™ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI™. Hypersensitivity reactions may manifest as severe intraocular inflammation

    Brand Name : Cimerli

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 06, 2022

    Polpharma CB

    Stock Recap
    #PipelineProspector

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