Polpharma B2B

Manufacturer of Generic Drugs and Active Pharmaceutical Ingredients

Pharmaceutical Works, Pelpińska 19, 83-200 Starogard Gdański, Poland



Polpharma is a leader on the Polish pharmaceutical market.

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

About Polpharma

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.

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.

Out-Licensing (OL)

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.

The Polpharma Group

What is most important for us, in the Polpharma Group, is the human. Supporting people with ideas and connecting people with passion who have a similar view of the world.

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.

Polpharma B2B to Attend CPhI China

One of the most prominent industry events in the Asian region is coming soon. Polpharma B2B has announced it will take a part in key event for the pharmaceutical industry, CPhI China 2018.

Polpharma B2B Continues its Presence at Trade Shows in 2018

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.

Polpharma B2B

Pharmaceutical Works

Pelpińska 19

83-200 Starogard Gdański

Poland

+48 22 364 64 11 +48 22 364 61 62 www.polpharmab2b.com www.api.polpharma.com www.polpharma.pl/ www.linkedin.com/company/polpharma
Strategic Partner, Farmaprojects

Santa Eulalia 240-242

L'Hospitalet de Llobregat

08902

Barcelona

Spain

+34 93 508 05 00 +34 93 508 05 01
Contract Manufacturing

ul Łokietka 10

98-200 Sieradz

Poland

+48 43 829 92 39 +48 43 829 92 31 +48 43 829 92 41
Latvia, Lithuania

18, E Ozeskienes St

LT-3000 Kaunas

Lithuania

+370 373 251 31 +370 373 251 31 www.polpharma.lt
Belarus

7-409, Bechterewa St

220026 Mińsk

Belarus

+375 172 91 59 98 +375 172 91 59 98 www.by.polpharma.com
Ukraine

8, Illinskaya Str

11 Entrance, Floor 5

04070 Kiev

Ukraine

+380 44 498 90 07 +380 44 498 93 87 www.polpharma.ua
Kazakhstan

Al-Farabi ave. 17/1

Business center ‘Nurly Tau’ 5B, 19th floor

050013 Almaty

Kazakhstan

+772 73 111 289 298 +772 72 584 348 www.kz.polpharma.com
Russia

Polskie Lekarstva LLC

Kosmodamianskaya Naberezhnaya 52, bld 5

115054 Moskwa

Russia

+74 95 721 36 97 (98) +74 95 231 79 76 +74 95 723 72 89 www.polpharma.ru
Uzbekistan

Chekhov St. 32

100031 Tashkent

Uzbekistan

+998 711 403 026/027 www.uz.polpharma.com
Azerbaijan, Armenia, Georgia

Caspian Business Centre

Dj Djabbarli St 44

Az 1065

Baku

Azerbaijan

+994 12 497 07 15 +994 12 497 07 15 www.az.polpharma.com www.am.polpharma.com www.ge.polpharma.com
Czech Republic

Organizační Složka

Květnového vítězství 332/31

149 00 Praha - Chodov

Czech Republic

+420 272 656 940 +420 272 681 435 www.cz.polpharma.com
Bulgaria

Polpharma Bulgaria

85 ‘Z’ Simeonovsko shousse blvd

Office center Magnolia, entrance B, floor 5, office 10

1700 Sofia

Bulgaria

www.bg.polpharma.com
Vietnam

59 A Ly Thai To Street

th floor, 425 Room

Hoan Kiem District

Hanoi

Vietnam

Polpharma SA Trade Office

6 Bobrowiecka Street

00-728

Warsaw

Poland

+48 22 364 64 11
Contract Manufacturing

10 Łokietka Street

98-200

Poland

+48 43 829 92 39 www.polpharmab2b.com/cm