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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, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API development to scale-up, at our FDA-approved plant in Central Europe. Our expert team provides high-quality, tailor-made services for small molecule API clinical candidates, with strong regulatory support and world-class facilities. Trusted by global partners, we specialize in complex chemical processes and deliver exceptional customer experiences. Polpharma API – Your reliable European CDMO partner.

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    INTERVIEW #SpeakPharma

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

    mic“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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    #SpeakPharma With Polpharma
    11 Sep 2023
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    VLOG #PharmaReel

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    ReelPharmaEuropean CDMO Partner & API SupplierEuropean CDMO Partner & API Supplier

    European CDMO Partner & API Supplier
    European CDMO Partner & API Supplier

    reelEuropean CDMO Partner & API Supplier

    Polpharma stands as your premier European CDMO partner and API supplier, offering end-to-end solutions from pre-clinical development to commercial manufacturing, with specialized capabilities in high-potent API production and cryogenics.

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2025

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    Corporate Presentation

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    GMP Certificate 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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    CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

    CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

    During the second quarter (Q2) of 2025, contract development and manufacturing organizations (CDMOs) made substantial investments in specialized therapeutic manufacturing. The quarter also saw CDMOs pursue high-value, complex manufacturing niches, particularly in antibody-drug conjugates (ADCs), cell and gene therapies (CGTs) and oligonucleotides.Alongside these trends, Q2 also saw CDMOs strengthen their footprint in the United States amid concerns over rising tariffs and unpredictable trade policies being enforced by the Trump administration.Regeneron Pharmaceuticals committed over US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to nearly double its US manufacturing capacity for biologics. Under this agreement, Fujifilm will manufacture and supply drug products for Regeneron at its large-scale facility in Holly Springs, North Carolina.Thermo Fisher Scientific announced plans to invest an additional US$ 2 billion in the US over four years, reinforcing its manufacturing and R&D capabilities. With 64 facilities spread across 37 states, Thermo Fisher aims to bolster American innovation and competitiveness. Similarly, Piramal Pharma announced a US$ 90 million investment plan for expanding two facilities in the US, thereby bringing its total investment in the country to US$ 570 million. View CDMO Activity Tracker for Q2 2025 (Free Excel Available)Veranova, Carbogen lead ADC wave; Axplora doubles down on HPAPI production in ItalyThe quarter saw substantial investments in ADC manufacturing. Veranova announced a US$ 20 million investment in bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. With this investment, Veranova will be able to provide a more comprehensive suite of services to its partners developing ADCs and other bioconjugates. Veranova’s total investment in the Devens facility now stands at over US$ 50 million. Swiss CDMO Carbogen announced a US$ 31 million co-investment with an unnamed Japanese investor to expand its capabilities across its Aarau and Neuland (Switzerland) facilities. The facility will address increasing demand for complex and high-value compounds such as ADC drug linkers.Axplora announced a further €35 million (US$ 41 million) expansion of its Farmabios site in Italy, doubling the facility to approximately 108,000 square meters by mid-2026. This investment raises its total spend on the site to over €80 million (US$ 94.05 million) since 2019, supporting the production of highly potent active pharmaceutical ingredients (HPAPIs). Farmabios now stands as a key hub in Axplora’s global CDMO network.Polish pharmaceutical manufacturer Polfa Tarchomin is positioning itself as a significant player in the European CDMO market through its investment in the Center for Development and Production of Highly Potent Drugs. This 12,000 square meter facility has two state-of-the-art production lines designed for filling vials and pre-filled syringes with an annual capacity of 26 million product units.Skyepharma’s projected annual revenues from oncology-linked activities touched €10 million (US$ 11.2 million). The CDMO’s facility in Saint-Quentin-Fallavier is equipped to handle cytotoxic and cytostatic compounds, and is one of the few facilities in France capable of managing HPAPIs for oral anticancer treatments. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Athena acquires Medipha Santé, Famar buys MiP Pharma’s German site to strengthen European footprintDuring the quarter, several CDMOs enhanced their strategic capabilities through M&As. Athena Pharmaceutiques acquired  Medipha Santé to build a fully integrated pharmaceutical services platform in Europe. Based in Paris, Athena has strengthened its commercial and regulatory toolbox by bringing aboard Medipha Santé’s 35-strong team, which supports over 100 partner organizations and files approximately 350 dossiers annually with ANSM and other European agencies. With this integration, Athena positions itself as a one-stop CDMO partner.With the acquisition of MiP Pharma’s sterile manufacturing site in Homburg, Germany, the Famar Group has expanded its capabilities in aseptic and lyophilized fill-and-finish operations. The acquisition has strengthened Famar’s position in sterile drug manufacturing. The CDMO now has seven manufacturing facilities in Europe.PCI Pharma Services’ acquisition of Ajinomoto Althea has established a world-class, large-scale manufacturing hub in the San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high-potent formulations such as ADCs. PCI Pharma is now amongst the few US-based CDMOs capable of comprehensive ADC manufacturing.Samsung Biologics’ strategic spinoff of its biosimilar business stood out as a significant corporate restructuring exercise during the quarter. The separation of Samsung Bioepis, tentatively renamed Samsung Epis Holdings, aims to enhance Samsung Biologics’ strategic focus and build client trust, as it eliminates potential conflicts between CDMO services and proprietary drug development. The move came after Samsung Biologics inked a contract worth 737.3 billion Korean won (US$ 518 million) with an undisclosed US pharmaceutical company.WuXi Biologics announced a US$ 167 million divestment of its German facility to Terumo and broke ground on a microbial production plant in China. National Resilience, which was launched five years ago as the US drug manufacturer dedicated to broadening access to medicines and protecting biopharma supply chains, said it is shuttering six of its 10 facilities. The company said the sites were “not being fully utilized.” View CDMO Activity Tracker for Q2 2025 (Free Excel Available) MilliporeSigma, Simtra form 5-year ADC alliance; Silexion partners Catalent for siRNA developmentMerck KGaA’s MilliporeSigma and Simtra struck a five-year strategic alliance, combining expertise across the ADC value chain to reduce development timelines and complexity for biopharmaceutical companies. Viralgen collaborated with Trogenix to rapidly scale product supply for TGX-007, an AAV gene therapy for glioblastoma (a type of cancer of the brain and spinal cord).  Silexion announced a collaboration with Catalent for small interfacing RNA (siRNA) development and manufacturing. Catalent’s Limoges (France) facility will conduct formulation development and clinical manufacturing for Silexion’s SIL204 candidate, supporting both systemic and intra-tumoral delivery formulations.Skyepharma’s collaboration with Eneapharm through the Skyehub platform aims to support the treatment of patients suffering from exocrine pancreatic insufficiency, including those affected by cystic fibrosis or pancreatic cancer. Orion Corporation reached an agreement with Shilpa Biocare for the distribution of recombinant human albumin in Europe.Meanwhile, Aenova announced the launch of its Aenovation program, an initiative designed to fast-track early development of pharmaceutical formulations. The program addresses the critical challenges of bioavailability and time-to-market faced by poorly soluble drug candidates. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Our view The quarter saw CDMO developments mimic the broader trends in the pharmaceutical industry, such as onshoring of critical manufacturing capabilities in the US, consolidation of specialized expertise through strategic partnerships, and the relentless focus on emerging therapeutic modalities that promise to transform patient care. With CDMOs continuing to invest in next-generation manufacturing capabilities, we expect the sector to play a crucial role in drug innovation. 
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    10 Jul 2025
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    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025. 
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    19 Dec 2024
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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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    27 Jun 2024
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    NEWS #PharmaBuzz

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    Polpharma Urges Swift Pharma Reform for Sustainable EU Access
    Polpharma Urges Swift Pharma Reform for Sustainable EU Access

    14 May 2025

    // PRESS RELEASE

    https://polpharma.pl/en/polpharma-group-joins-the-call-to-action-to-finalize-pharmaceutical-reform-and-secure-early-and-sustainable-healthcare-for-european-patients/

    PRESS RELEASE
    14 May 2025
    Share Share
    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
    Share Share
    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
    Share Share
    Addressing Nitrosamine Risks in Pharmaceutical Manufacturing
    Addressing Nitrosamine Risks in Pharmaceutical Manufacturing

    10 Oct 2024

    // PRESS RELEASE

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

    PRESS RELEASE
    10 Oct 2024
    Share Share
    Polpharma acquires Ziołolek
    Polpharma acquires Ziołolek

    01 Oct 2024

    // PRESS RELEASE

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

    PRESS RELEASE
    01 Oct 2024
    Share Share
    Polpharma & MSN Lab Announce Strategic Distribution Partnership
    Polpharma & MSN Lab Announce Strategic Distribution Partnership

    23 Sep 2024

    // PRESS RELEASE

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

    PRESS RELEASE
    23 Sep 2024
    Share Share

    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Acetazolamide

    Poland

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

    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-15

    DMF Number : 10383

    Submission : 1993-07-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-371 - Rev 02

    Issue Date : 2020-08-04

    Type : Chemical

    Substance Number : 454

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10013

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2024-01-24

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12658-0359

    Start Marketing Date : 1982-01-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (40kg/40kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Wooshin Labotech Co., Ltd.

    Registration Date : 2020-10-19

    Registration Number : 20201019-210-J-595

    Manufacturer Name : Pharmaceutical Works Polpharma S.A.

    Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland

     VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Alendronate Sodium

    Poland

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

    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-12-16

    Pay. Date : 2014-11-28

    DMF Number : 16962

    Submission : 2003-11-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-273 - Rev 04

    Issue Date : 2021-05-12

    Type : Chemical

    Substance Number : 1564

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10241

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2008-12-04

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12658-0489

    Start Marketing Date : 1999-11-24

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF, CA arrow-down
    ✖
    Available Reg. Filing : ASMF, CA
    AUDIT
    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Etodolac

    Poland

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

    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-12-16

    Pay. Date : 2014-11-28

    DMF Number : 11405

    Submission : 1995-03-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-134 - Rev 03

    Issue Date : 2024-12-02

    Type : Chemical

    Substance Number : 1422

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10101

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2013-05-10

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2020-05-12

    Registration Number : 20200324-209-J-453(2)

    Manufacturer Name : Pharmaceutical Works Polpharma S.A.

    Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland

     VMF ASMF, CA arrow-down
    ✖
    Available Reg. Filing : ASMF, CA
    AUDIT
    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Hydrochlorothiazide

    Poland

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

    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-01-06

    Pay. Date : 2014-12-29

    DMF Number : 17599

    Submission : 2004-08-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2004-058 - Rev 06

    Issue Date : 2024-04-12

    Type : Chemical

    Substance Number : 394

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF11020

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2006-12-28

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12658-0544

    Start Marketing Date : 1982-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (30kg/30kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2021-05-04

    Registration Number : 20180611-209-J-86(3)

    Manufacturer Name : Pharmaceutical Works Polpharma S.A.

    Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland

     VMF ASMF, CN... arrow-down
    ✖
    Available Reg. Filing : ASMF, CN, CA
    AUDIT
    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Ibandronate Sodium

    Poland

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

    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-12-12

    Pay. Date : 2016-06-21

    DMF Number : 25638

    Submission : 2011-12-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-073 - Rev 00

    Issue Date : 2023-02-20

    Type : Chemical

    Substance Number : 2771

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10116

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2021-07-20

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Wooshin Labotech Co., Ltd.

    Registration Date : 2019-08-02

    Registration Number : No. 2417-3-ND(1)

    Manufacturer Name : Pharmaceutical Works Polpharma S.A.

    Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland

     VMF Others AUDIT
    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Lamotrigine

    Poland

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

    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-02-25

    Pay. Date : 2014-06-11

    DMF Number : 20548

    Submission : 2007-05-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-128 - Rev 02

    Issue Date : 2023-02-16

    Type : Chemical

    Substance Number : 1756

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10228

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2016-12-14

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Wooshin Labotech Co., Ltd.

    Registration Date : 2021-11-01

    Registration Number : 20210611-209-J-1025(1)

    Manufacturer Name : Pharmaceutical Works Polpharma S.A.

    Manufacturer Address : 19, Pelplinska street, 83-200 Starogard Gdanski, Poland

     VMF ASMF, CN arrow-down
    ✖
    Available Reg. Filing : ASMF, CN
    AUDIT
    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Risedronate Sodium

    Poland

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

    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-13

    Pay. Date : 2012-12-11

    DMF Number : 20384

    Submission : 2007-03-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-126 - Rev 02

    Issue Date : 2022-05-09

    Type : Chemical

    Substance Number : 2572

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10015

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2010-01-07

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : YuYu Pharmaceutical Co., Ltd.

    Registration Date : 2024-11-26

    Registration Number : 20100226-121-G-15-07(7)

    Manufacturer Name : Pharmaceutical Works Polpharma S.A.

    Manufacturer Address : 19, Pelplinska Street., 83-200 Starogard Gdanski, Poland

     VMF ASMF, CA arrow-down
    ✖
    Available Reg. Filing : ASMF, CA
    AUDIT
    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Sildenafil Citrate

    Poland

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

    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-08-11

    Pay. Date : 2016-06-13

    DMF Number : 23930

    Submission : 2010-06-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-073 - Rev 04

    Issue Date : 2024-11-19

    Type : Chemical

    Substance Number : 2270

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10011

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2013-01-30

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12658-0483

    Start Marketing Date : 1998-03-27

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF, CN... arrow-down
    ✖
    Available Reg. Filing : ASMF, CN, CA
    AUDIT
    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Tadalafil

    Poland

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

    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-03-07

    Pay. Date : 2017-11-15

    DMF Number : 24590

    Submission : 2011-01-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-150 - Rev 02

    Issue Date : 2023-10-24

    Type : Chemical

    Substance Number : 2606

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10011

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2020-01-24

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12658-0439

    Start Marketing Date : 2003-11-21

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF, CN arrow-down
    ✖
    Available Reg. Filing : ASMF, CN
    AUDIT
    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Vardenafil Hydrochloride

    Poland

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

    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-09-15

    Pay. Date : 2015-08-21

    DMF Number : 25174

    Submission : 2011-08-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-106 - Rev 02

    Issue Date : 2024-05-29

    Type : Chemical

    Substance Number : 2782

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10080

    Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND

    Initial Date of Registration : 2019-04-03

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12658-0463

    Start Marketing Date : 2003-08-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Wooshin Labotech Co., Ltd.

    Registration Date : 2018-10-28

    Registration Number : 20181028-211-J-269

    Manufacturer Name : Zakłady Farmaceutyczne Polpharma SA

    Manufacturer Address : ul. Peplińska 19, 83-200 Starogard Gdański, Poland

     VMF ASMF, CN... arrow-down
    ✖
    Available Reg. Filing : ASMF, CN, CA
    AUDIT
    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Drugs in Development

    read-more
    read-more
    • 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: Other Small Molecule

    Sponsor: Ryvu Therapeutics

    Deal Size: $1.0 million Upfront Cash: Undisclosed

    Deal Type: Agreement June 07, 2023

    Polpharma CB

    01

    Polpharma

    Poland
    arrow
    ChemOutsourcing
    Attending
    • 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.

    Product Name : RVU120

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    June 07, 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.

    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: Other Small Molecule

    Sponsor: Pikralida biopharmaceutical

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership July 19, 2022

    Polpharma CB

    02

    Polpharma

    Poland
    arrow
    ChemOutsourcing
    Attending
    • 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.

    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.

    Product Name : PKL-021

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    July 19, 2022

    Polpharma CB

    Stock Recap
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    Data Compilation
    #PharmaFlow

    Virtual Booth

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    KEY PRODUCTS

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    Services

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    API Manufacturing

    Discover their expertise for : API Manufacturing

    Custom Synthesis & Manufacturing

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    01

    API CUSTOM SYNTHESIS & MANUFACTURING

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

    Pharma Service : API Manufacturing

    Polpharma

    Polpharma API is a CDMO and the largest Polish manufacturer of active pharmaceutical ingredients (APIs). It can accommodate a broad range of chemical processes to support customers in custom synthesis and contract manufacturing of APIs.

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    Category : Custom Synthesis & Manufacturing

    Sub Category : Custom Synthesis

    • fda
    • EDQM
    • WHO-GMP

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

    Pharma Service : API Manufacturing

    API CUSTOM SYNTHESIS & MANUFACTURING

    Polpharma API is a CDMO and the largest Polish manufacturer of active pharmaceutical ingredients (APIs). It can accommodate a broad range of chemical processes to support customers in custom synthesis and contract manufacturing of APIs.

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    API Custom Synthesis & Manufacturing

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    02

    CUSTOM API MANUFACTURING

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

    Pharma Service : API Manufacturing

    Polpharma

    Polpharma API has cGMP compliant & FDA-approved multipurpose facilities that offer custom manufacturing and development services for active pharmaceutical ingredients. It offers clinical & commercial APIs from pilot plant to multi-ton manufacturing scale.

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    Category : Custom Synthesis & Manufacturing

    Sub Category : Overview

    • fda
    • EDQM
    • WHO-GMP

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

    Pharma Service : API Manufacturing

    CUSTOM API MANUFACTURING

    Polpharma API has cGMP compliant & FDA-approved multipurpose facilities that offer custom manufacturing and development services for active pharmaceutical ingredients. It offers clinical & commercial APIs from pilot plant to multi-ton manufacturing scale.

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    API & Drug Product Development

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    KEY SERVICES

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    TOP RANKED SUPPLIER FOR:

    Polpharma full-view
    Development of High-Value/Low-Volume Niche-Complex APIs
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    Lab-Scale And/Or Pilot Scale Experimentation
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    Highly Potent API (HPAPI) Manufacturing
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    Low-Temperature Processes
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    Inspections and registrations

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    FDA

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    01

    FDA Audited

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    ChemOutsourcing
    Attending

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-05-25

    Polpharma

    City : Starogard Gdanski

    State :

    Country/Area : Poland

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-05-25

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    02

    FDA Audited

    USA
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    ChemOutsourcing
    Attending

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-29

    Polpharma

    City : Starogard Gdanski

    State :

    Country/Area : Poland

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-29

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    03

    FDA Audited

    USA
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    ChemOutsourcing
    Attending

    District Decision : No Action Indicated

    Inspection End Date : 2012-09-20

    Polpharma

    City : Starogard Gdanski

    State :

    Country/Area : Poland

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-09-20

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    04

    FDA Audited

    USA
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    ChemOutsourcing
    Attending

    District Decision : No Action Indicated

    Inspection End Date : 2009-01-29

    Polpharma

    City : Starogard Gdanski

    State :

    Country/Area : Poland

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-01-29

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    EDQM

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    01

    GMP Certified

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    Polpharma

    Type : GMP Certificates

    Number : ISF.405.98....

    EudraGMDP Key : 171765

    Country : Poland

    Issue Date : 2024-08-23

    Post Code :

    NCA Ref :

    City : Warsaw

    Polpharma CB

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    02

    GMP Certified

    EU
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    ChemOutsourcing
    Attending

    Polpharma

    Type : GMP Certificates

    Number : ISF.405.57....

    EudraGMDP Key : 170465

    Country : Poland

    Issue Date : 2024-06-13

    Post Code :

    NCA Ref : 168058770557...

    City : Sieradz

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    03

    GMP Certified

    EU
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    Attending

    Polpharma

    Type : GMP Certificates

    Number : ISF.405.57....

    EudraGMDP Key : 169910

    Country : Poland

    Issue Date : 2024-05-24

    Post Code :

    NCA Ref : WTN_0037_03

    City : Sieradz

    Polpharma CB

    Product
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    04

    GMP Certified

    EU
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    ChemOutsourcing
    Attending

    Polpharma

    Type : GMP Certificates

    Number : ISF.405.57....

    EudraGMDP Key : 169911

    Country : Poland

    Issue Date : 2024-05-24

    Post Code :

    NCA Ref : WTN044

    City : Sieradz

    Polpharma CB

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    05

    GMP Certified

    EU
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    ChemOutsourcing
    Attending

    Polpharma

    Type : GMP Certificates based on a Distant Assessment

    Number : ISF.405.57....

    EudraGMDP Key : 169909

    Country : Poland

    Issue Date : 2024-05-24

    Post Code :

    NCA Ref : 168058770557...

    City : Sieradz

    Polpharma CB

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    Stock Recap
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    06

    GMP Certified

    EU
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    ChemOutsourcing
    Attending

    Polpharma

    Type : GMP Certificates

    Number : ISF.405.57....

    EudraGMDP Key : 169908

    Country : Poland

    Issue Date : 2024-05-24

    Post Code :

    NCA Ref : WTN_0037_03

    City : Sieradz

    Polpharma CB

    Product
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    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    07

    GMP Certified

    EU
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    ChemOutsourcing
    Attending

    Polpharma

    Type : GMP Certificates

    Number : ISF.405.57....

    EudraGMDP Key : 169907

    Country : Poland

    Issue Date : 2024-05-24

    Post Code :

    NCA Ref : WTN044

    City : Sieradz

    Polpharma CB

    Product
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    08

    GMP Certified

    EU
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    ChemOutsourcing
    Attending

    Polpharma

    Type : GMP Certificates

    Number : ISF.405.38....

    EudraGMDP Key : 169263

    Country : Poland

    Issue Date : 2024-04-24

    Post Code :

    NCA Ref : 167031645823...

    City : Starogard Gdanski

    Polpharma CB

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    Stock Recap
    #PipelineProspector

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    #PharmaFlow

    09

    GMP Certified

    EU
    arrow
    ChemOutsourcing
    Attending

    Polpharma

    Type : GMP Certificates

    Number : ISF.405.22....

    EudraGMDP Key : 168462

    Country : Poland

    Issue Date : 2024-02-27

    Post Code :

    NCA Ref : 167031645823...

    City : Starogard Gdanski

    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
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    10

    GMP Certified

    EU
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    ChemOutsourcing
    Attending

    Polpharma

    Type : GMP Certificates

    Number : ISF.405.22....

    EudraGMDP Key : 168464

    Country : Poland

    Issue Date : 2024-02-27

    Post Code :

    NCA Ref : 167031645823...

    City : Starogard Gdanski

    Polpharma CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

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    GDUFA

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    GDUFA fees paid

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

    Paid in : 2025

    Polpharma

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Zaklady Farmaceutyczne Polphar...

    Business Address : 19, Pelplinska Str Starogard...

    FEI Number : 3002807920

    Country : Poland

    Paid in : 2025

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    ABOUT THIS PAGE

    Contact Polpharma and get a quotation

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