Polpharma B2B Manufacturer of Generic Drugs and Active Pharmaceutical Ingredients
Polpharma B2B Unit is a world-class provider of high-quality products and services that offers customised support through its international sales team and experienced research and development (R&D) experts. The company provides you with tailor-made solutions addressing all of your business needs.
Polpharma is one of the leading European manufacturers, with sites located in Poland, the heart of Europe.
It provides a wide range of integrated solutions, including active pharmaceutical ingredients (API), finished dosage formulation (FDF) licensing out and supply and contract manufacturing and contract development and manufacturing organisation (CDMO) services.
Manufacturing of APIs for drug development
Polpharma B2B manufactures APIs at its current good manufacturing practice (cGMP) compliant and US Food and Drug Administration (FDA) approved multipurpose facilities. These plants passed FDA inspections in 2004, 2009, 2012, 2015 and most recently in May 2018.
The company ensures its manufacturing processes are in line with stringent requirements of customers and healthcare authorities, including the FDA, the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM), the Southern Kaduna Fulani Development Association (SKFDA), the Polish Main Pharmaceutical Inspectorate, the Pharmaceuticals and Medical Devices Agency (PMDA) and Brazilian health regulatory agency ANVISA.
Strict compliance with cGMP procedures, well-documented standards of practice (SOP), and a modern quality control laboratory also ensures that all APIs produced by Polpharma are of the highest quality.
Finished dosage forms
More than 20 years of experience in supplying finished dosage form (FDF) products demonstrates Polpharma as a reliable partner that 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 optimal market share and sales throughout 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 comply with good manufacturing practices (GMP).
Contract manufacturing organisation services for medical products
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 both prescription (Rx) and over-the-counter (OTC) drugs, dietary supplements, medical devices, and cosmetics.
High-quality standards, combined with project management and competitive pricing, makes Polpharma an ideal contract manufacturing organisation (CMO) for pharmaceutical companies interested in outsourcing their manufacturing activities.
Drug master file (DMF) documentation for all Polpharma’s products are prepared in accordance with the latest EDQM, International Council for Harmonisation of Technical Requirements (ICH), PMDA and the FDA.
Polpharma CDMO service
Polpharma is a European API producer with cGMP-compliant and FDA-approved multi-purpose facilities. It also provides a CDMO service.
The company’s custom development and manufacturing services are dedicated to clients looking for a European manufacturing site for their active substances.
With broad experience in complex chemistries, dedicated project management and R&D team, corporate quality system and service excellence, we deliver tailored solutions to meet your every need.
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
Polpharma’s portfolio includes 700 products, with another 250 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 Central and Eastern Europe (CEE) and Commonwealth of Independent 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.
Products and Services
Finished Dosage Forms (FDF)
The Polpharma Group develops its own generic product dossiers, including more than 25 dossiers every year at its three research and development (R&D) centres.
Polpharma’s services include EU standard dossiers for finished dosage formulations based on active pharmaceutical ingredients (API) developed in-house or outsourced. The company’s out-licensing (OL) portfolio secures the most comprehensive offer for its clients.
Contract Manufacturing (CM)
Polpharma offers customised contract manufacturing (CM) services, with full analytical support in its five European current good manufacturing practices (cGMP) compliant production plants.
Active Pharmaceutical Ingredients (API)
Located in Poland, Polpharma is a significant European active pharmaceutical ingredient (API) producer with current good manufacturing practice (cGMP) compliant and US Food and Drug Administration (FDA) approved multipurpose facilities.
API Contract Development and Manufacturing Organisation (API CDMO)
Polpharma B2B has broad experience in complex chemistries and it offers custom contract development and manufacturing organization (CDMO) services for clients looking for a European manufacturing site for their active substances.
Polpharma Finished Dosage Formulation Dossier – Under Development
This white paper outlines Polpharma B2B's finished dosage formulations (FDF) that are currently under development.
Polpharma B2B’s API Product List
This whitepaper showcases Polpharma B2B's product pipeline of active pharmaceutical ingredients (API) in development, including Apixaban, Baricitinib and Rivaroxaban.
WuXi Biologics’ Biologics Manufacturing Facility, Dundalk, Ireland
Agilent Technologies’ New Pharmaceutical Facility, Frederick, Colorado
Polpharma is a manufacturing company, and all manufacturing processes have an impact on the environment and environmental resources.Read more
Last year was full of fruitful meetings that strengthened business relationships. This year, Polpharma B2B continues its presence at key trade shows to discuss the possibility of its B2B offer and find the perfect solutions to your challenges.Read more
Polpharma has announced that the Main Pharmaceutical Inspectorate (MPI) have completed two inspections at its active pharmaceutical ingredients (API) plant in Poland.Read more
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