Active Pharmaceutical Ingredients

Polpharma B2B – Manufacturer of Generic Drugs and Active Pharmaceutical

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 organization (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 with no observations on the form 483 in 2004, 2009, 2012 and 2015.

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 organization 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.

Polpharma’s business-to-business (B2B) unit offers a customised support and a key account management approach and has an experienced international sales team


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