About polpharma

Polpharma is a modern international pharmaceutical company that started its activity in the domestic Polish market and has become one of the top 20 generic drug manufacturers in the world. Today Polpharma employs nearly 7 300 people and has 8 manufacturing sites in Poland, Russia and Kazakhstan, as well as 6 Research and Development centers.

We manufacture prescription-only medicines and medicines restricted to hospital use, OTC medicines, food supplements and medical devices. Our principal domains are cardiovascular, gastrointestinal, neurological, respiratory, anti-infectious, dermatological and ophthalmic drugs.

We provide drugs of the highest quality and reliable medical knowledge. We are one of the most innovative companies in Poland according to the ranking prepared by the Institute of Economic Sciences of the Polish Academy of Sciences (PAN). We contribute to scientific development as well as health education and promotion.

Polpharma is the largest manufacturer of Finished Dosage Forms in Poland and one of the largest Active Pharmaceutical Ingredients manufacturers in Europe, competing successfully in the developed markets of EU and United States. Our well-balanced and expanding portfolio, along with scientific know-how and experience, allow us to offer attractive solutions to the pharmaceutical companies worldwide.




POLPHARMA B2B



In order to boost Polpharma’s internationalization and sales to third parties with a customer-centric perspective in mind, a Business to Business unit has been created to provide a wide range of integrated solutions:

As a highly customer-centric organization, Polpharma B2B Unit delivers a wide range of products and services. We offer APIs supply and custom-made synthesis from EU & US FDA-approved site, FDF licensing-out and supply, also based on vertically integrated API. This in turn constitutes to our Clients a guarantee of high security of the supply chain and IP competitive products. Possessing strong R&D centers we are able to provide our Partners with tailor-built solutions addressing all of their business needs. In addition, Polpharma B2B is providing Contract Manufacturing services from top-class facilities located in the center of Europe giving access to a variety of technologies supported by a skilled Project Management team.

In B2B environment we use our skills to build a vision and bring the best solutions to our partners. Our experience and expertise is crucial for better understanding of your needs in a strictly regulated pharma environment. Operating in the pharmaceutical industry, we are accepting the responsibility for human health and life. That is why the quality of our products and the safety of patients are our priorities:

  • We care for quality at each stage of the product development, production, storage, distribution and sale.

  • Our products are manufactured in accordance with the highest standards of Good Manufacturing Practice (GMP).

  • We have GMP certificates issued by the Polish Main Pharmaceutical Inspectorate for all drugs and substances manufactured.

  • We use the latest technologies which ensure the safety of products, employees and the environment.

API

Custom-made synthesis

As a significant European API producer with cGMP-compliant and FDA-approved multipurpose facilities, we are present in 60+ countries in 6 continents. Regular and successful FDA audits enabled us to register and sell a number of APIs in the US market thus confirming our reliability and credibility towards all Polpharma business partnerships around the world.

In addition to “ready to use” API products, 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, multi-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 (ASMF, CEP, US DMF, Japanese DMF, Chinese DMF). 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.

Product list Pipeline CUSTOM-MADE SYNTHESIS

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FDF

Finished dosage form

Always seeking to be at the forefront of generic products development, Polpharma Group develops more than 25 dossiers every year at its 4 R&D centers. Our goal is to offer the most attractive and interesting products meeting registration timelines and time-to market approach.

We have a comprehensive portfolio of CTD dossiers meeting EU requirements and complying with cGMP. Our experience of more than 20 years with third parties, allows us to offer full support to submit Marketing Authorization Applications for our products and regulatory support to ensure that MA is obtained successfully and in a timely manner. Our clients receive comprehensive intellectual property assistance and are assured of developing strategy 2x2 for blockbuster products, successful launch with minimal risk and constant price optimization.

We guarantee that our dossiers will be adapted to meet specific local requirements. We have successfully registered dossiers in Latin America, Australia, Africa and CIS. Our key products have stability studies conducted for countries in climatic zone IV.
Registration documentation for finished dosage forms is prepared in the CTD format compliant with the EU requirements.

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CM

Contract manufacturing

Polpharma offers 80 years of experience and expertise in drug manufacturing. As one of the top 20 generic drug manufacturers and the leader on the Polish pharmaceutical market, we provide extensive capabilities and capacity for a wide variety of solid and liquid dosage forms.
We offer customized contract manufacturing services with full analytical support in our five European cGMP-compliant production plants. We have broad experience in production of medicinal products (Rx and OTC), dietary supplements, medical devices and cosmetics. High quality standards combined with professional project management and competitive pricing makes POLPHARMA an attractive CMO for pharmaceutical companies interested in outsourcing their manufacturing activities.

Contract manufacturing services
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