Accelerate your product launches

In addition to its CDMO activities, Unither Pharmaceuticals offers licensing opportunities to access high value-added drugs and medical devices, developed within its technological platforms.

Designed and evaluated by our teams, these products are immediately available for registration, market launch, and industrial production.

The objective is to facilitate faster market entry, while ensuring a high level of quality, regulatory compliance, and industrial reliability.

A fast, simple, and differentiating solution

Spray Production
  • No R&D investment
    Products are formulated, documented and sometimes already registered in several countries
  • Reduced time-to-market
    Direct access to industrializable solutions
  • Differentiating dosage forms
    BFS single-dose, stick-packs, sprays, vials, etc.
  • No conflict of interest
    Unither is a pure-play CDMO, with no proprietary brands
  • Guaranteed manufacturing
    Products are manufactured at our EMA, FDA, ANVISA-certified sites, etc.

Products tailored to your markets

Our licensing solutions cover a wide range of therapeutic areas:

Collaboration models

Collaboration
  • Drug with existing Marketing Authorization:
    → Licensing agreement or transfer of Marketing Authorization possible
  • Drug without Marketing Authorization in your territory:
    → Sale of the dossier (CTD) for submission by your teams
Drug licensing
Dispositif médical certifié CE
  • CE-certified medical device
    → Granting of distribution rights in certain geographical areas, as desired
Medical device licensing

Tailored regulatory services

Unither also offers a range of optional extras:

  • Strategic regulatory advice for market launch
  • Dossier updates for submission (after acquisition)
  • Support for Marketing Authorization submissions
Discover our regulatory support

Why trust us?

Over 30 years of experience in contract manufacturing

Products developed in-house using tried-and-tested technologies

Modular and adjustable documentation based on the regulatory specificities of each market

Products marketed in over 100 countries

A global industrial network, covering four continents and recognized by multiple certifications

FAQ - Pharmaceutical out-licensing

In the pharmaceutical industry, out-licensing allows a company to commercialize a product developed by a third party under license or through an assignment of rights, without going through the full R&D process. This allows stakeholders to rapidly extend their market reach and product ranges without having to worry about regulatory aspects. Unither Pharmaceuticals has a unique portfolio of out-licensing products, in addition to its CDMO activity.

Our turnkey products allow our partners to focus on marketing and distribution while we handle production and compliance.

Yes. Our CTD dossiers are designed to allow for local adjustments (claims, information document, language, packaging, national regulations, etc.).
If necessary, our Regulatory Affairs teams can assist with submission and correspondence with local authorities to ensure the registration process goes smoothly.

Yes. Licensed medicines are manufactured at Unither sites with GMP certifications (EMA, FDA, ANVISA, etc.).
Our production lines already produce these products, which ensures continuity of supply, full traceability, and compliance with health authority requirements.