Polfa Tarchomin S.A DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

RFQ update indenter and matrix Empagliflozin

01 Apr 2025

// PRESS RELEASE

RFQ Punches indenter & matrix Empagliflozin – ABM

27 Mar 2025

// PRESS RELEASE

Z61/5914/1 – Stamps, indenter and Empagliflozin matrix

27 Mar 2025

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

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DIGITAL CONTENT

1 Vlog #PharmaReel, 11 Corporate Content #SupplierSpotlight, 2 Data Compilation #PharmaFlow, 37 News #PharmaBuzz

media
1 Vlog #PharmaReel
11 Corporate Content #SupplierSpotlight
2 Data Compilation #PharmaFlow
37 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

5 All APIs, 1 USDMF, 1 CEP/COS, 5 Listed APIs

5 All APIs
1 USDMF
1 CEP/COS
5 Listed APIs

FINISHED DOSAGE FORMULATIONS

72 FDF Dossiers, 2 Europe, 70 Listed Dossiers

72 FDF Dossiers
2 Europe
70 Listed Dossiers

SERVICES

API Manufacturing, Drug Product Manufacturing, API & Drug Product Development, Packaging

pharmaServices
API Manufacturing
Drug Product Manufacturing
API & Drug Product Development
- 1 Preformulation & Material Science
- 4 Formulation Development
Packaging
- 3 Contract Services

KEY SERVICES

CMO of Parenteral Dosage Forms, R&D & Production of Highly Potent Injectables

CMO of Parenteral Dosage Forms
R&D & Production of Highly Potent Injectables

INSPECTIONS & REGISTRATIONS

15 EDQM

inspections
15 EDQM

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

About

Polfa Tarchomin located in Warsaw is pharmaceutical company with long tradition and experience in manufacturing and sales of pharmaceutical products. Our core business is related with: anti-infectives, CNS medicines, dermatology drugs and human insulin preparations. In general we are in position to produce: tablets and coated tablets; hard gelatinous capsules; dry bottled syrups; sterile powders for injections in glass vials and liquids in glass ampoules; insulin cartridges; dermatological: aerosols, solutions, gels. Polfa Tarchomin will be in position to produce high-potency injectables (vials and prefilled syringes) in 2025.

CPhI North America CPhI North America

Industry Trade Show

Not Confirmed

20-22 May, 2025

Pennsylvania Conv Center, Philadelphia
DIHADDIHAD

Industry Trade Show

Attending

29 April-01 May, 2025

Dubai World Trade Centre
PharmaVenuePharmaVenue

Industry Trade Show

Attending

26-27 May, 2025

Madrid

CONTACT DETAILS

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Country

Poland

Address

A. Fleminga 2 street, 03-176 Warsaw

Telephone

+48 225108333

info@tzf.pl

Website

https://www.polfa-tarchomin.com.pl/en/home/

https://www.linkedin.com/company/polfa-tarchomin/

YouTube

https://www.youtube.com/@PolfaTarchominSA

Digital content

Explore the latest content creation from this company

VLOG #PharmaReel

Taking on Challenges, Developing Effective Treatments

CORPORATE CONTENT #SupplierSpotlight

Product List 2023

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Corporate Presentation

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API Product List 2023

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FDF Product List 2023

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Contract Manufacturing Services

GMP Certificate 2024

Corporate Video

Polfa 200 Years

Facility Video

TZF IMA- FAT Tests

DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals

The contract development and manufacturing organization (CDMO) sector witnessed significant activity in the first quarter (Q1) of 2025, characterized by strategic investments, facility expansions, and collaborative partnerships.The quarter saw some significant deals. WuXi Biologics agreed to sell its vaccine manufacturing facility in Dundalk, Ireland, to Merck for € 500 million (US$ 521 million). Quadria Capital announced the acquisition of a 10 percent stake in Aragen for US$ 100 million. This investment will help Aragen accelerate its research and development efforts.Some CDMOs, like India-based Syngene International and Belgium-based Ardena expanded their presence in the US market. Syngene completed the acquisition of its first US biologics facility that it had purchased from Emergent Manufacturing Operations Baltimore for US$ 36.5 million. And, leading nanomedicine developer Ardena purchased a drug manufacturing unit in New Jersey from Catalent. View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Axplora expands its ADC capacities; Quotient Sciences wraps up HPAPI unit upgradeThe antibody-drug conjugate (ADC) market saw considerable investments by CDMOs. Axplora expanded its commercial payload production capabilities at its Le Mans site in France, reinforcing its position as a leading player in ADC manufacturing. This expansion is part of the France 2030 program and builds on Axplora’s track record of supplying 40 percent of the world’s marketed ADCs and 50 percent of ADCs approved by the US Food and Drug Administration (FDA).Samsung Biologics said it will support a series of LigaChem Biosciences’ ADC programs at its new dedicated ADC facility. Similarly, Cerbios-Pharma announced significant enhancements to its ADC production capabilities. Cerbios also announced the expansion of its high potency active pharmaceutical ingredients (HPAPIs) production capabilities. On March 31, Cerbios-Pharma got acquired by Healthcare Advanced Synthesis, a leading developer of APIs, HPAPIs and anticancer compounds. Both these global players are based in Switzerland. Overall, HPAPIs saw significant investments. Quotient Sciences made headlines with the successful completion of a US$ 1.4 million project designed to improve high potency handling capabilities at its Philadelphia (US) facility. The initiative focused on upgrading infrastructure and implementing advanced safety protocols to manage HPAPIs more effectively.Polfa Tarchomin achieved significant milestones in enhancing its pharmaceutical manufacturing capabilities. The company successfully completed the site acceptance test (SAT) for its vial filling and packaging line at the Center for Development and Production of Highly Potent Drugs, ensuring full functionality and compliance with good manufacturing practice (GMP) standards.Additionally, Polfa Tarchomin is installing a high-tech, high-containment robotic ONCO LINE designed for aseptic production of highly potent pharmaceutical products, including lyophilisates and liquid formulations in vials and pre-filled syringes. Developed in collaboration with leading global suppliers, this line supports multiple packaging formats and comes with advanced systems. With an annual production capacity of up to 6 million units, this line will set a new benchmark in pharmaceutical manufacturing.In a significant development for analytical testing, SK Pharmteco launched an enhanced laboratory specifically designed for HPAPIs. The new facility is in California (US). View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Evonik expands RNA portfolio; Catalent to support Galapagos’ CAR-T therapy trialsThe success of mRNA vaccines and the growing interest in RNA therapeutics is luring CDMOs to rapidly expand their capabilities in this emerging area. Evonik, in collaboration with ST Pharm, announced plans to expand its portfolio of RNA and nucleic acid therapeutic services during Q1. The partnership enables Evonik to provide customized nucleic acids from ST Pharm alongside its portfolio of lipid and lipid nanoparticle (LNP) drug product development services.ReciBioPharm secured a grant from the Bill & Melinda Gates Foundation to advance RNA manufacturing technologies that meet FDA standards with a focus on improving access to RNA therapeutics in low- and middle-income countries.The cell and gene therapy sector also witnessed remarkable activity in Q1 2025. Catalent announced it will support Galapagos’ decentralized CAR T therapy trials for GLPG5101 for relapsed/refractory non-Hodgkin lymphoma indications.Similarly, AGC Biologics announced it will manufacture and supply lentiviral vectors for Adaptimmune’s solid tumor cell therapy initiatives. And, Genenta and AGC Biologics strengthened their cell therapy manufacturing pact through a collaboration agreement. This grants Genenta access to the exclusive GMP suite at the AGC Biologics Cell and Gene Center of Excellence in Milan, dedicated to manufacturing cell therapy products. View CDMO Activity Tracker for Q1 2025 (Free Excel Available) EUROAPI, StrainChem join hands to develop peptides; Fermion expands flow chemistry capabilitiesEven traditional therapeutics like peptides and small molecules saw considerable investments by CDMOs. For instance, EUROAPI and StrainChem announced a collaborative venture to develop liquid phase peptides. The partnership aims to harness advanced synthesis techniques and innovative technologies for more efficient peptide manufacturing. Through this collaboration, EUROAPI and StrainChem will offer their customers a one-stop shop solution for peptides. In one of the most ambitious expansions announced this quarter, CordenPharma unveiled plans to invest over € 1 billion (US$ 1.10 billion) over the next three years in building and expanding small, medium, and large peptide manufacturing facilities across Europe and the US. That includes a new greenfield facility for peptide manufacturing in the Basel region of Switzerland, valued at over € 500 million (US$ 553 million).In obesity treatments, Viking Therapeutics agreed to pay US$ 150 million to CordenPharma for the production of its dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) agonist VK2735.In a show of confidence, Indian CDMO Neuland Labs’ board approved a ₹ 3.42 billion (approximately US$ 42 million) capital expenditure plan. The approved capex is earmarked for enhancing the company’s peptide synthesizer reactor capacity and building additional capacity to meet growing demand.In the small molecule space, Fermion announced a strategic investment to expand its flow chemistry capabilities, aiming to enhance processes and sustainability by integrating continuous flow techniques into manufacturing. This technology offers advantages in scalability, process control, and safety, positioning Fermion at the forefront of pharmaceutical innovation.Recipharm announced a major expansion of its aseptic filling capabilities, encompassing process development, pilot-scale production, and clinical supply operations. Similarly, Curia announced significant expansions to its global network of sterile fill-finish sites, aiming to enhance production capacity, streamline supply chains, and improve overall quality in sterile pharmaceutical manufacturing. View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Our viewDuring Q1 2025, the CDMO sector continued to evolve towards higher-value and more complex services. This only underscores the crucial role CDMOs are playing in supporting growth and innovation in the pharmaceutical industry.With the Trump administration in the US triggering a global tariff war, drugmakers have no option but to reshape their supply chains. And this means more business for CDMOs that manufacture drugs in the US. In the coming quarter, we expect strong dealmaking and increased focus on innovation in the CDMO sector.

Impressions: 1700

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.

Impressions: 2895