Manufacturer of Generic Drugs and Active Pharmaceutical Ingredients
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Polpharma is a leader on the Polish pharmaceutical market and an international pharmaceutical group that operates in central and Eastern Europe, the Caucasus and central Asia.
Active pharmaceutical ingredients
Polpharma's portfolio includes 600 products with another 200 being developed. The company is expanding its branded generic/OTC business, food supplements and medical devices from Poland to other markets with a primary focus on CEE and CIS regions.
We offer Rx and OTC medicines and pharmaceuticals restricted to hospital use, food supplements and medical devices. Our key therapeutic areas are cardiology, gastroenterology, neurology, dermatology, respiratory, anti-infectious and ophthalmic drugs.
The company develops its operations in the field of biotechnological drugs such as biosimilars and biobetters. We are one of the leading European manufacturers of active pharmaceutical ingredients (APIs), which compete in the developed markets of the EU and US.
Under our B2B unit, we offer customised support and key account management approach with our experienced international sales team. We have gained the trust of our customers worldwide with our high-quality products and services.
The B2B unit provides a wide range of integrated solutions including:
- API supply
- FDF licensing out and supply
- Contract manufacturing services
Polpharma is one of the leading API producers in more than 60 countries on six continents, and is growing in Europe, North America and Asia.
The company is focusing on further expansion in Latin America, Middle East and North Africa. We provide full regulatory support until marketing authorisation.
Located in the centre of Europe near Gdansk International Airport and seaports in Gdansk and Gdynia, our cGMP-compliant and FDA-approved multipurpose facilities enables manufacturing of products in line with rigorous requirements of customers and healthcare authorities.
This includes FDA, EMA, EDQM, SKFDA, PMDA, ANVISA and Polish main pharmaceutical inspectorate requirements.
Regular FDA audits and registration documentation (ASMF, CEP, US DMF, Japanese DMF, Chinese DMF) issued in an eCTD format allows us to register and sell a number of APIs in the US market.
Finished dosage forms
Polpharma Group develops its own generic product dossiers, including more than 25 dossiers every year at its four R&D centers and offers both licensing out and in-house or external supply.
More than 20 years of experience in supplying FDFs to third parties makes us a reliable partner as we anticipate our customers' needs. Our main objective is a successful product launch at day zero of patent expiry to enable our partners to gain the maximum market share and maximise their sales through the product's entire lifecycle.
Our expertise in the generics market guarantees a successful launching process and minimal risk due to a non-interrupted supply and 2x2 API and manufacturer strategy for blockbuster products.
We have an extensive portfolio of comprehensive CTD dossiers that meets EU requirements and complies with good manufacturing practices (GMP).
Polpharma offers 80 years of experience and expertise in drug manufacturing. We provide extensive capabilities and capacities for various solid and liquid dosage forms.
We offer customised contract manufacturing services with full analytical support in our five European cGMP-compliant production plants. The company has broad experience in the production of medicinal products (Rx and OTC), dietary supplements, medical devices and cosmetics.
High quality standards combined with project management and competitive pricing makes Polpharma an ideal CMO for pharmaceutical companies interested in outsourcing their manufacturing activities.
With a turnover of $1bn and in-depth experience, Polpharma is among the top 25 generic companies in the world. It is a valued employer for more than 7,500 people in Poland and international markets, and is committed to health education and the development of science.
83-200 Starogard Gdański
+48 22 364 61 62
+48 22 364 64 11