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.

  • 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.

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

  • Selected products with stability studied conducted for countries in climatic zone IV
  • Minimum risk in supply: 2x2 strategy for blockbuster products
  • Improve competitiveness and quality of products
  • Both in-house and external manufacturing capabilities
  • Hard-to-make & Generic Plus products

Key milestone

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2011
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2014
2015
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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

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Value added services

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

  • Audit report availability of suppliers
  • QA consultancy - audits conducted on behalf of our customers
  • QP release - Finished Product ready to be marketed in EU
  • Additional batch documentation
  • Product Quality Reviews
  • Dossier Compliance
  • Release site
  • Periodic Safety Update Report (PSUR)
  • Risk Management Plan (RMP)
  • Addendum to the clinical overview
  • ICH stability studies and monitoring
  • Storage of stability samples on request
  • Batch analysis for finished products
  • Finished product analysis
  • Analytical method transfers
  • Transport according to customer needs
  • Import/Export services
  • Artwork management

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

  • License + Supply
  • License + Tech Transfer + Supply of API (if vertically integrated)
  • License + Tech Transfer (if internal production limitations for specific countries)
  • 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

  • Intellectual property knowledge and expertise
  • Support in assessment of patent situation of offered products on the territory of client’s interest
  • Worldwide Regulatory knowledge and expertise
  • Design of registration strategies
  • Execution and support of registration procedures
  • Full Regulatory support within the area of authorization of medical products

Adaptation to new markets

New products tested in IV climatic zone conditions

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

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