Polpharma B2B Manufacturer of Generic Drugs and Active Pharmaceutical Ingredients
Polpharma is an international pharmaceutical group based in Poland, which operates in Central and Eastern Europe (CEE), the Caucasus, and central Asia.
Active pharmaceutical ingredients (API)
Polpharma’s portfolio includes 600 products, with another 200 being developed. The company is expanding its branded generic / over-the-counter (OTC) business, food supplements, and medical devices from Poland to other markets, with a primary focus on CEE and Commonwealth of Independant States (CIS) regions.
The company offers Rx and OTC medicines, as well as pharmaceuticals that are restricted to hospital use, food supplements, and medical devices. Polpharma’s 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. The company is one of the leading European manufacturers of active pharmaceutical ingredients (API), which compete in the developed markets of the EU and US.
Under Polpharma’s business-to-business (B2B) unit, it offers customised support and a key account management approach, with the company’s experienced international sales team. Polpharma has gained the trust of its customers worldwide, with high-quality products and services.
The B2B unit provides a wide range of integrated solutions including:
- API supply
- Finished Dosage Formulation (FDF) licensing out and supply
- Contract manufacturing services
- Contract development and manufacturing organisation (CDMO) 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, the Middle East, and North Africa. It provides full regulatory support until marketing authorisation.
Located in the centre of Europe near Gdańsk International Airport and seaports in Gdańsk and Gdynia, Polpharma’s current good manufacturing practice (cGMP) compliant and US Food and Drug Administration (FDA) approved multipurpose facilities enable manufacturing of products in line with rigorous requirements of customers and healthcare authorities.
This includes the FDA, European Medicines Agency (EMA), European Directorate for the Quality of Medicines (EDQM), Southern Kaduna Fulani Development Association (SKFDA), Pharmaceuticals and Medical Devices Agency (PMDA), ANVISA, and Polish main pharmaceutical inspectorate requirements.
Regular FDA audits and registration documentation, including active substance master file (ASMF), certificates of suitability (CEP), US drug master files (DMF), Japanese DMF, and Chinese DMF, issued in an electronic common technical document (eCTD) format allows Polpharma 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 research and development (R&D) centers. It also offers both licensing out and in-house or external supply.
More than 20 years of experience in supplying FDFs to third parties makes Polpharma a reliable partner as it anticipates its customers’ needs. The company’s main objective is a successful product launch at day zero of patent expiry to enable partners to gain the maximum market share and maximise their sales through the product’s entire lifecycle.
Polpharma’s expertise in the generics market guarantees a successful launching process and minimal risk due to a non-interrupted supply and 2×2 API and manufacturer strategy for blockbuster products.
The company has an extensive portfolio of comprehensive common technical document (CTD) dossiers, which meet EU requirements and complies with good manufacturing practices (GMP).
Polpharma offers 80 years of experience and expertise in drug manufacturing, providing extensive capabilities and capacities for various solid and liquid dosage forms.
The company offers customised contract manufacturing services, with full analytical support in its five European cGMP-compliant production plants. Polpharma 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 contract manufactruing organisation (CMO) for pharmaceutical companies interested in outsourcing their manufacturing activities.
Polpharma CDMO service
Polpharma B2B offers custom CDMO services for clients looking for a European manufacturing site for their active substances.
With broad experience in complex chemistries, dedicated project management and R&D teams, a corporate quality system, and service excellence, the company delivers tailored solutions to meet your every needs.
Polpharma B2B’s strengths and expertise within CDMO include:
- Successful tracking of FDA inspections
- Development from lab to market
- Professional project management
- World-class regulatory service
- State-of-the-art R&D
- cGMP pilot plant
- Comprehensive experience
- Easy-access location
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.
Products and Services
Polpharma B2B’s Product Pipeline
This white paper showcases Polpharma B2B's product pipeline of active pharmaceutical ingredients (API) in development, including Baricitinib, Ozanimod, and Sotagliflozin.
Polpharma Active Pharmaceutical Ingredient (API) Product List
This brochure shows Polpharma B2B's active pharmaceutical ingredient (API) product portfolio.
Polpharma B2B has announced it will be present at the CPhI North America in Philadelphia, PA.Read more
83-200 Starogard Gdański
Santa Eulalia 240-242
L'Hospitalet de Llobregat
ul Łokietka 10
18, E Ozeskienes St
7-409, Bechterewa St
8, Illinskaya Str
11 Entrance, Floor 5
Al-Farabi ave. 17/1
Business center ‘Nurly Tau’ 5B, 19th floor
Polskie Lekarstva LLC
Kosmodamianskaya Naberezhnaya 52, bld 5
Chekhov St. 32
Caspian Business Centre
Dj Djabbarli St 44
Květnového vítězství 332/31
149 00 Praha - Chodov
85 ‘Z’ Simeonovsko shousse blvd
Office center Magnolia, entrance B, floor 5, office 10
59 A Ly Thai To Street
th floor, 425 Room
Hoan Kiem District
6 Bobrowiecka Street
10 Łokietka Street