High quality dossier

Always seeking to be at the forefront of generic products development, Polpharma Group develops 25 dossiers every year at its 3 R&D centers.

Our goal is to offer the most attractive and interesting products meeting registration timelines and time-to-market approach.

We have a comprehensive portfolio of CTD dossiers meeting EU requirement and complying with cGMP.

We provide full support to submit Marketing Authorization Applications for our products and regulatory support to ensure that MA is obtained positively and in a timely manner. We guarantee that our dossiers will be adapted to meet specific local requirement. We have successfully registered dossiers in Latin America, Australia, Africa and CIS.

  • Selected products with stability studied conducted for countries in climatic zone IV
  • Minimum risk in supply: API and manufacturer 2x2 strategy for blockbuster products
  • Constant price improvement to enhance our customers’ competitiveness
  • Change Management control to improve the competitiveness and quality of products
  • Customers satisfaction & loyalty: most of our customers renew supply agreement and our top 10 clients have on average 4 molecules in supply
  • Both in-house and external manufacturing capabilities

Key milestone


First worldwide supply to third parties of injectable forms

Launches of the first oral forms: Simvastatin, Citalopram and Gabapentin

Expansion of injectable portfolio with the launches of Pantoprazole and Clarithomycin

Launches of Metoprolol Succinate: Europe, LATAM and Asia

Launch of Orlistat in Europe with the biggest multinational generic companies

30 different molecules in supply with 500 SKUs (counting units)

Orlistat: Ingoing supply in 12 countries where our clients have 46% of market share

41 different molecules in supply with 571 SKUs (counting units)

Territory expansion to new markets in Asia and America


Value added services

For Finished Dosage Forms, we offer a wide range of value added services to meet the needs of our customers:

Licensing out

New products constitute a key factor for corporate growth when product life cycles are continuously getting shorter.

Our services include EU standard dossiers for finished dosage formulations based on vertically integrated APIs.

What can we offer?

Continuous licensing-out activity of our generic products with favorable conditions for our clients

Dossiers meeting European guidelines adapted to local non-EU requirements

Very wide portfolio to offer comprehensive dossiers

10 products in development and 20 products in early stage development

Excellent products with CTD dossiers meeting EU requirements

New products predominantly based on internally manufactured API

Comprehensive manufacturing experience focused on lowering production cost

3 x R&D New products developed In 3 R&D centers

Key competitive advantages

Flexibility in license models

License + Supply

License + Tech Transfer + Supply of API (if vertically integrated)

License + Tech Transfer (if internal production limitations for specific countries)

Production Safety

Risk management – 2 API suppliers in a dossier

Production for domestic markets guarantees production continuity

Alternative in-house packaging for non-EU manufacturers

Selected external manufacturing sites mainly in Europe

Wide range of value - added services

Adaptation to new markets

New products tested in IV climatic zone conditions

Adaptation of dossiers to different non-EU market requirements (including US)