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.

The group also offers both licensing out and in-house or external supply.

Almost 20 years of experience in supplying finished dosage forms (FDF) to third parties makes Polpharma a reliable partner as it 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 the optimum market share and optimise their sales through the product’s entire lifecycle.

The company has an extensive portfolio of comprehensive common technical document (CTD) dossiers, which meet EU requirements and comply with good manufacturing practices (GMP).

Polpharma provides full support to submit marketing authorisation applications (MAA) for its products alongside regulatory support to ensure marketing authorisations (MA) are obtained successfully and in a timely manner.

The company guarantees that its dossiers will be adapted to meet specific local requirements. It has already registered dossiers in Latin America, Australia, Africa and Commonwealth of Independent States (CIS) locations.

Polpharma’s key products have stability studies conducted for countries in climatic zone IV.

For FDFs, Polpharma offers a wide range of value-added services to meet the needs of its customers, including:

  • High-quality services
  • Pharmacovigilance
  • Quality control
  • Logistics services

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