Ready-to-distribute solutions, with simplified implementation

As part of its out-licensing program, Unither Pharmaceuticals offers a range of ready-to-use, certified medical devices developed in-house and designed for immediate registration and commercialization in your priority markets. These are high-value-added products, developed using advanced technology: stick pack, multi-dose vial, spray, BFS, etc.

  • Pre-certified products (CE or international equivalent)
  • Complete technical dossiers available
  • Customizable packaging, claims, or leaflets
  • Controlled production at our certified ISO 13485-compliant industrial sites

Products adapted to multiple segments

Our portfolio of white-label medical devices that are ready for distribution covers several therapeutic areas:

  • Ophthalmology: lubricants, cleansing solutions
  • ENT / Respiratory care: decongestion, cold relief

Technologies available:

Blow-Fill-Seal

Multi-doses with preservatives

Sprays

Product List

Collaboration models

Licensing out

Licensing of certified devices:

  • Licensing rights for our CE-certified medical devices.
  • Customizable commercial materials: packaging, leaflet, visual identity.

Sale of technical dossiers:

  • Complete transfer of regulatory documentation (tech file).
  • Support available for adaptation or re-registration according to your target market.

Why choose a licensed Unither medical device?

Products developed in line with the requirements of the European Regulation (MDR)

CE-certified or internationally validated devices

Certified ISO1348-compliant industrial sites

Global presence: products marketed in over 100 countries

FAQ - Medical device licensing

Unither Pharmaceuticals’ medical devices are CE marked, in accordance with the European Regulation (EU) 2017/745 (MDR). They are approved by Notified Bodies of the European Union.
In addition, Unither follows international quality standards (ISO 13485 is generally associated with this type of production, although not explicitly mentioned on their site).

Yes, Unither offers several ophthalmic medical devices available for out-licensing (assignment or transfer of Marketing Authorization, sale of pharmaceutical dossiers).
These products are available as sterile single-doses (BFS) or multi-doses with preservatives, and some are already registered in certain markets.

No. We are a CDMO with no proprietary brand. There is no conflict of interest with your commercial operations. We handle production and compliance and leave marketing and distribution to our partners.