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We deliver quality

API Polpharma is a significant European producer of Active Pharmaceutical Ingredients delivering products to pharmaceutical companies worldwide. We are present on 6 continents, in 60+ countries, and our market share is constantly growing. Our well-balanced and expanding portfolio, along with our scientific know-how and experience, allow us to offer attractive solutions for drug developers.

We provide a one-stop shop solution of vertically integrated services from API development to FDF formulation and manufacturing, scale-up capabilities based on in-house or external custom developed technologies, to regulatory support.

Regular FDA audits enabled us to register and sell a number of APIs in the US market and confirm our reliability and credibility towards our business partners around the world. At Polpharma quality comes first.

Our history

  • 1935

    Polpharma's foundation - manufacturing on Bayer technology

  • 1939

    Taken over by Bayer

  • 1949

    Reconstruction of Polpharma after The Secound World War

  • 1949

    First product after the war - redistrilled water in glass ampoules

  • 1951

    Minister of Industry established Starogard Pharmaceutical Plant, making salicylates and sulfonamides.

  • 1959

    Plant becomes part of Union Of Pharmaceutical Industry and renames to Pharmaceutical Works "Polfa" Starogard

  • 1995

    ,,Polfa" Starogard transformed into a Join Stock Company with 100% shares belonging to the State Treasury

  • 1995

    Company returned to its old name - Pharmaceutical Works POLPHARMA S.A.

  • 2000

    Spectra Holding and Prokom Investments (Polish capital) bought the majority of the Company shares converting it to a private company

  • 2007

    Strategic alliance with Akrikhin, major generic pharma player in the Russian market

  • 2010

    Acquisition of antibiotic business of Bioton Poland together with a cephalosporin manufacturing plant in Duchnice, Poland

  • 2011

    Polpharma becomes a key partner of Chimpharm, Kazahstan

  • 2012

    Polpharma becomes a major shareholder of Polfa Warsaw, Poland

  • 2012

    First laboratories are opened in a biotech center in the Gdańsk Science and Technology Park

  • 2014

    Decision about building BIOTECH Manufacturing facility in Duchnice

  • 2017

    Decision about Parental Manufacturing consolidation and building new facility for sterile products in Starogard

  • 2018

    FDA audyt for API Plant

  • 2019

    Spin-off of Biotech buissness as Polpharma Biologics SA

  • 2019

    Completion of the investment in Sieradz (non-sterile liquids)

  • 2020

    Integration IPOCHEM to Polpharma API

Core competences

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.

We offer solutions tailored to your needs:

Values
Expertise
& experience
Regulatory
service
Intellectual
property

Capabilities

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.

Solid state
chemistry
Hazardous
chemistry
Our
capacity
Green
chemistry
Production
facilities
Network
of alliances

We invest with your future in mind

A completely rebuilt and modernized production facility for the production of API was put into operation in February 2017 extending our production capacity.We invest in innovative technologies which enhance production efficiency, the comfort of medication delivery and safety of our processes for humans and the environment

Our newly modernized facility is compliant with the highest manufacturing standards. Equipment delivered by globally recognized suppliers ensures 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

Tailored solutions

Professional
and experienced team

Team of key account managers guarantee customized service packages 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.

Control over your product

The scope of our services includes preparation of comprehensive regulatory documentation in an eCTD format.

The process is performed by the R&D, RA, QA and other Operational departments of Polpharma. All of this with the sole purpose of maintaining full control over your product.

Full support

Polpharma API 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.

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

  • 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

  • Process upscaling

  • Development of new salts and polymorphic forms of APIs

  • Adjusted particle size distribution (PSD)

  • Non-infringing process development

  • Multipurpose production lines

  • High GMP standards

  • High quality products

  • Excellent service

  • Wide reaction classes in FDA approved facilities

RECENT NEWS
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Values

OUR VALUES EQUAL COMMITMENT TO:
  • Offer custom-made synthesis and individual approach to non-standard queries and projects
  • Highest confidentiality and IP protection standards
  • Find innovative solutions to use our APIs in breakthrough finished dosage forms
  • Pioneer non infringing solutions applied in the process development stages, at minimum risk exposure for all of our customers
  • Serve our Client’s best interest at all times
  • Offer competitive prices for our superior quality products and services
  • Foster sustainable development, product stewardship and efficient supply chain
  • Build on science and expertise, state-of-the-art technology, best design processes and practices to deliver attractive solutions for drug development
KAIZEN MEANS CHANGE FOR BETTER:
  • Comprised of highly skilled professionals, our Customer Service Team is committed to helping your business grow in the dynamic pharma environment. We put our customers at the core of what we do. Thus, in our ongoing effort to provide you the highest quality of service, we adopted the Kaizen methodology at the heart of which lies the idea of sustained continual improvement.

Offer custom-made synthesis and individual approach to non-standard queries and projects

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Experience & Expertise

Our prime assets are the knowledge and extensive expertise of our people.

A key to the success is a combination of in-house expertise and effective co-operation with scientific institutions.

Our company enjoys the benefit of the experience of specialized external laboratories and institutions both Polish and international, the majority of which are located in Germany, Italy, Sweden, Switzerland, The Netherlands, China and India.

The external cooperation is carried out in the following areas:

  • Innovative processes and process techniques development
  • Analytical method development and validation
  • Kilo-lab and pilot-plant up-scaling

To implement wide regulations into our processes, we developed the following practices:

  • Pipeline Committee
  • Project Management
  • Resources planning program
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Regulatory service

We provide full support from the beginning of cooperation to the marketing authorization. We assist customers through the entire registration lifecycle process. All deficiency letters from regulatory agencies are treated with highest priority to provide full responses before deadline.

Our registration documentation for APIs (ASMF, CEP, US DMF, JAPANESE DMF, CHINESE DMF) is prepared in an eCTD format using the software DocuBridge. It has been submitted and evaluated by authorities from: Europe, USA, Japan, Canada, Israel, Australia &New Zealand, Brasil, Mexico, China, India, Egypt, Korea, Singapore, Indonesia, Malaysia, Philippines, Sudan, Vietnam and many others.

We work in close cooperation with key global health authorities.

Global Authorities: US FDA compliant, EDQM, SKFDA, PMD, ANVISA compliant, Russian MIT, Polish GIFcompliant

ISO: ISO 14001, OHSAS 18001, PN-N 18001

REGULATORY DOCUMENTATION: EU DMF/ CEP, US DMF, Chinese DMF, Japanese DMF, Korean DMF

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Intellectual property

INTELLECTUAL PROPERTY:
  • API Polpharma is a holder of several process patents and the rate is targeted to minimum 10 applications per year
  • Time-to-market and First-to-File business oriented objectives have intensified creative work at all levels of API development
  • We respect legal principles governing intellectual property
  • We provide financial incentives for creation of our invention
  • We actively pursue the protection of our intellectual property rights however we respect the freedom of culture movement and freedom of knowledge
PATENT APPROACH:

Respecting all third party intellectual rights, our own patent team is dedicated to designing and defending our processes. We are experienced in designing new synthesis routes for producing APIs; our patent portfolio proves it.

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Solid state chemistry

  • Particle size modulation and optimization
  • Polymorph study and crystalization, new salts
  • Co-crystals and adducts
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Hazardous chemistry

The use of hazardous chemistry has an aim to reduce the number of synthesis steps as well as the amount of impurities. Our key hazardous chemistry includes:

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

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
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Green Chemistry

Polpharma is engaged in efforts to make its environmental contribution more extensive than ever. We pledge to contribute to a sustainable future for the environment through technological innovation that reduces pollution. We follow the European ISO Standards.

  • Integrated Pollution prevention and Control Licence (IPPC)
  • Certificate of ISO 14001:2004 (UKAS accreditation)
  • Certificate of ISO 18001:2007 (OHSAS and PN-N, UKAS accreditation)
  • Waste management (own waste incinerator; capacity 200 kg/h, solids and liquids)
  • Sewage management (own waste water treatment plant; capacity 8500 m3/day)
  • VOC Emission Control System
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Production facilities

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

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.

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Network of alliances

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