WORLD CLASS SERVICE

    OUR OFFER

    Polpharma provides a one-stop shopping solution of integrated services ranging from API development to finished dosage formulation and scale-up capabilities based on in-house or customer developed technology and the support of the registration file.

    Professional and experienced team of key account managers guarantee customized service package for each client. We are here to advise in project evaluation, educate our clients about our technology and recommend appropriate solutions. We provide assistance in every step of the purchasing process.

    WE OFFER

    • Full support from molecule development to drug delivery
    • Development and production of generic APIs
    • Custom synthesis and toll manufacturing
    • Intellectual Property expertise and guidance
    • Regulatory compliance
    • Development of new salts and polymorphic forms of APIs
    • Adjusted particle size distribution (PSD)
    • Non-infringing process development
    • Wide reaction classes in FDA approved facilities
    • Multipurpose production lines
    • High GMP standards
    • High quality products
    • Excellent service

    SOLUTIONS TAILORED TO YOUR NEEDS

    In addition to a diverse and broad product portfolio of superior quality, excellent customer service and efficient supply chain, Polpharma B2B offers custom-made synthesis service for clients looking for a European manufacturing site for their active substances.

    Polpharma B2B offers full support from process optimization, analytical method development & validation, to process scale-up to pilot plant (kg scale) and fully commercial, multiple tons synthesis in EU cGMP, FDA (US), Anvisa (Brazil), PMDA (Japan) & KFDA (Korea) approved facility.

    The scope of our services includes also preparation of comprehensive regulatory documentation in an eCTD format. The entire process is led by professional project management team coordinating for you all project activities performed by the R&D, RA, QA and other Operational departments of Polpharma - all of this with the sole purpose of you maintaining a full control over your product.

    WE INVEST WITH YOUR FUTURE IN MIND

    We are responsive to the ever-changing dynamics of global markets. Seeing how rapidly the demand for active pharmaceutical ingredients grows, we decided to significantly increase productivity within this area by investing into a complex modernization of API production lines.

    The enterprise will allow us to expand manufacturing capacity and thus become more flexible when responding to customers’ needs.

    The new facility will be compliant with the highest manufacturing standards. Equipment delivered by globally recognized suppliers will ensure safety of API production in conformity with Polpharma quality standards as well as increasing cGMP requirements.

    Our production area has been designed to enable parallel manufacturing of API on two additional production lines – to accommodate for expanding demand of our key products.

    Core competencies & services

    Process upscaling

    • 5 multipurpose production lines
    • GMP Pilot plant,
      temperature range -40° to 120° C
    • Well equipped R&D for innovative chemistry
    • Process development
    • Optimization to up scaling simulation
    • DoE, Chemometrics, QbD, PAT

    Hazardous chemistry

    • Grignard Chemistry, Hydrogenation
    • Strong base handling – Sodium metal, hydride
    • Reaction with sodium amide
    • Reactions with Lewis Acid
    • Reactions with liquid and/or gas ammonia and Chlorine
    • Bromination, Bisphosphonation
    • Friedel Crafts Alkylation

    Solid state chemistry

    • Particle size modulation and optimization
    • Polymorph study and crystallization, new salts
    • Co-crystals and adducts

    Network of Alliances

    • Impurity synthesis
    • Chiral purification
    • Continuous process
    • Biocatalysis
    • Supercritical fluid chemistry and analysis
    • Peptide chemistry
    • Polymerisation chemistry
    • Supply chain management

    Environment-friendly operations

    • RTO – Regenerative thermal oxidizer, recycling to balance PMI, hazardous material management, green chemistry initiatives

    Quality, optimization and customer satisfaction
    are the driving forces behind our work

    Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF).

    Material and product testing is performed in line with the European and United States Pharmacopeias. However, our products can be additionally tested in compliance with the customer’s specifications.

      Production facilities

    Polpharma utilizes up-to-date technologies, which ensure the safety of products, employees, and the natural environment.

      We have the capabilities...

    We have the capabilities to provide customers with materials ranging from clinical quantities up to in-market supply. We have full and vertical integration of processes from R&D, pilot plant, scale-up to the manufacturing leverage of our competences in place so that cost-effective and on-time solutions are delivered to our partners. API manufacturing is carried out in cGMP-compliant and FDA-approved multipurpose plant.

      Comprehensive list of basic processes

    • Amidation
    • Alcylation
    • Acetylation
    • Bromination
    • Bisphosphonation
    • Chlorination
    • Chlorosulphonation
    • Cyclization
    • Coupling
    • Carboxylation
    • Dehydrogenation
    • Esterification
    • Friedl-Craft’s alcylation
    • Grignard’s reaction
    • Hydrogenation
    • Methylation
    • Metho-/Ethoxylation
    • Oxidation/Reduction
    • Phosgenation (with triphosgene)
    • Saponification
    • Strong base reactions

      Available Capacity

      Dedicated Multipurpose
    Glass lined 90,000 L 40 reactors 342,000 L 165 reactors
    Stainless steel - 25,000 L 15 reactors
    Auxiliary tanks - 150,000 L
    Tank Farm 900 m3 -


    Equipment type

    • Reactors
    • Columns
    • Crystallizers
    • Centrifuges
    • Dryers
    • Filter-dryers
    • Mills Micronizers

    Operating ranges

    • Temp. –20°C to +200°C
    • Pressure –1 to +10 bars
    • pH in the full range


    Operating ranges
    Pilot Plant

    • Temp. –80°C to +200°C
    • Pressure –1 to +10 bars
    • pH in the full range

    REGULATORY SERVICE

    We provide full support from the beginning of cooperation up to the marketing authorization. Registration documentation for API (ASMF, CEP, US DMF, Japanese DMF) is prepared in an eCTD format using the DocuBridge software. Documentation is prepared in accordance with the highest quality standards. It has been submitted and evaluated by authorities from Europe, USA, Japan, Canada, Israel, Australia & New Zealand, Brazil, Mexico, China, India, Egypt, Korea, Singapore, Indonesia, Malaysia, Philippines, Sudan, Vietnam and many others. Head of Polpharma Regulatory Team is an Expert in one of EDQM API Working Groups.

    We work in close cooperation with key global health authorities: EMA and EDQM (Europe), FDA and USP (USA) and TPD (Canada) and manufacture our products in agreement with the most rigorous requirements of USFDA, EMA, EDQM, SKFDA, PMDA, ANVISA and Polish Main Pharmaceutical Inspectorate.

    New requirements and guidelines appear every year which enforce higher quality of both measuring processes and that of finished API. In order to maintain the position of one of the best on the market, we not only follow requirements but we are ahead of them.

    COMPLIANCE WITH REGULATIONS

    GLOBAL AUTHORITIES

    USFDA compliant, EDQM, SKFDA, PMD, ANVISA compliant, Polish GIF compliant

    ISO

    ISO 14001, OHSAS 18001, PN-N 18001

    REGULATORY DOCUMENTATION

    Regulatory documentation (DMF/CEP) recent and restrictive requirement from authorities

    Out-licensing offer

    Our services include EU standard dossiers for finished dosage formulations based on APIs developed in-house or outsourced. Our out-licensing portfolio secures the most comprehensive offer for our clients.

    What can we offer to our partners?

    • High level of customer service
    • Excellent products with CTD dossiers meeting EU requirements
    • Regulatory knowledge and expertise
    • Full support in developing registration strategies to meet the customers’ needs
    • Execution and support of registration procedures upon customers’ request
    • QA service and Pharmacovigilance service (PSUR)
    • Intellectual property expertise
    • Professional and competent team skilled in project management techniques
    • Partnership in a win-win strategy

    What makes us different from licensing competitors?

    Vertically integrated products

    Relatively low cost production

    Comprehensive offer and business service




    CONTACT US:   salesb2b@polpharma.com