FDF

Licensing-out and supply

  • 14 years of experience in FDF supply to third parties in 40 countries, more than 25 dossiers a year developed by 4 R&D Centers
  • Successful launch of products at day zero of patent expiry and registration in Latin America, Australia, Africa and Russia
  • 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

Dossier list Dossiers under development

Key milestones

2001
2001

First worldwide supply to third parties of injectable forms

2002

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

2002
2008

First supply to third parties from in-house production

2008

Expansion of injectable portfolio with the launches of Pantoprazole and Clarithromycin

2009
2009

Launches of Metoprolol Succinate:
Europe, LATAM and Asia

2011

Launch of Orlistat in Europe with the biggest multinational generic companies

2011
2012
2012

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

2013

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

2013
2014

In-house production transfer of Simvastatin

2014

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

2015

Territory expansion to new markets in Asia and America

2015

11 dossiers under development become available

Value added services

Logistic services

  • Transport according to customer needs
  • Import/Export services
  • Artwork management

Quality services

  • Audit report availability of suppliers
  • QA consultancy service:
    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

Pharmacovigilance

  • Periodic Safety Update Report (PSUR)
  • Risk Management Plan (RMP)
  • Addendum to the clinical overview

Quality Control

  • ICH stability studies and monitoring
  • Storage of stability samples on request
  • Batch analysis for finished products
  • Finished product analysis
  • Analytical method transfers