Development and manufacturing for ENT treatments: multi-technology expertise

A rapidly evolving ENT market: practicality, efficacy, and safety

The ENT market is rapidly evolving, driven by increasing demand for practical and effective solutions: nose, throat, and ear sprays, isotonic or hypertonic saline solutions, ear care products, “cough & cold” syrups, and preservative-free pediatric formats.

In this context, laboratories are looking for CDMOs capable of combining galenical innovation, speed of execution, and international compliance.

Unither specializes in sterile and non-sterile liquid forms. Thanks to its presence on four continents (Europe, United States, Brazil, China), the company supports the development and manufacturing of ENT/OTC products with a high level of regulatory compliance (EMA, FDA, ANVISA, NMPA).

ENT / OTC formats we can produce

Liquid solutions adapted to patient needs and global market requirements.

Blow-Fill-Seal

Sprays

Stick packs

Vials

Development of ENT / OTC products

Production

Unither supports your ENT/OTC projects from development to commercial production, with recognized expertise in all liquid forms.

An integrated process

  • Pre-formulation and galenical optimization

  • Analytical development & ICH stability

  • Formulation / pump / bottle compatibility

  • GMP pilot batches and industrial scale-up

  • Multi-region regulatory support

Technical mastery of liquid forms

We handle both simple solutions and complex formulations (suspensions, emulsions, sensitive active ingredients) thanks to proven expertise in:

  • stability, viscosity, homogeneity

  • spray performance (plume, droplets)

  • secure management of sensitive substances

Agility and speed of execution

For a demanding OTC market, we offer:

  • Rapid re-formulation

  • Quick packaging adjustments

  • Flexible multi-site lines to improve time-to-market

Learn more

An integrated process

  • Pre-formulation and galenical optimization

  • Analytical development & ICH stability

  • Formulation / pump / bottle compatibility

  • GMP pilot batches and industrial scale-up

  • Multi-region regulatory support

BFS - Sprays - Flacons - StickPack

Out-licensing – our turnkey documentation and products (ENT/OTC)

Unither offers a portfolio of ENT products ready for registration that cover market needs:

  • Throat sprays and nasal sprays (medical devices and drugs)

  • Isotonic and hypertonic saline solutions

  • Liquid “cough & cold” sticks

  • Syrups and oral solutions

  • Formulations integrating Carragelose®

This portfolio facilitates a rapid market launch with proven formulas, comprehensive stability studies, and international compliance.

Out-licensing

Our Proprietary Technologies

 Table: Our Proprietary Technologies
BFS (Blow-Fill-Seal) Volume Category Status Dossier Country
Isotonic Saline Solution 0.9% 5 mL Rhinology, Ophthalmology Medical Device (ls) CE Mark Contact us
Multi-Purpose Isotonic 0.9% 5 mL Eyes, Nose, Ear, Wound, Inhalation MD (IIa) CE Mark Contact us
Seawater 5 mL Rhinology Medical Device (lls) CE Mark Contact us
Ofloxacin 1.5mg/0.5mL 0.5 mL Ear Medicine CE Mark Contact us

Our proprietary technologies

Carragelose

Carragelose

With the integration of Carragelose, a unique muco-adhesive technology offering a natural protective barrier against viruses and irritants, Unither expanded its portfolio of innovative solutions for the nose and throat. This technology complements our current range of unique technologies, such as Unistick®, and our international expertise in Blow-Fill-Seal, enabling the development of high-performance nasal sprays, oral solutions, and ENT products that are adapted to patient expectations and international regulatory requirements.

Key advantages:

  • Natural physical barrier against viruses and irritants

  • Prolonged hydration of mucous membranes

  • Efficacy demonstrated in several clinical studies

  • Safe, proven, and well-tolerated ingredients

  • Suitable for throat sprays, nasal sprays, and eye drops

Carragelose is available in several ENT and ophthalmic formulations available for out-licensing.

Find out more

Why trust us?

Talk to our experts

Global presence on four continents

Multi-technology expertise: BFS, multidose, sticks, sprays, bottles

Significant experience in OTC & medical devices

Agility: rapid re-formulation, packaging adaptations and optimization, reliable and fast execution.

End-to-end: pre-formulation, ICH stability, GMP pilot batches, industrialization, regulatory support

Do you have a project?

Talk to our experts

Simonne FARINA

OTC Director

Isabelle HERBET

Business Development Manager

Julie DELVAUX

Business Development Manager

Murielle DORSO

Business Development Manager

Do you have any questions? - Consult our FAQ

We operate several sites specialized in sterile single doses and ENT products in Europe, the United States, Brazil, and China. Our offering covers complete development: formulation, excipient selection, analytical development, stability studies, clinical batches, and industrial validation. We also provide support during regulatory procedures and tech transfer to the group’s production sites.

Blow-Fill-Seal (BFS) technology forms, fills, and seals the container in a single step, using a fully aseptic process with no direct human intervention, in a fully controlled environment. Our lines are suitable for preservative-free products and operate in compliance with international GMPs (EU, FDA, ANVISA, NMPA).

Blow-Fill-Seal (BFS) technology forms, fills, and seals the container in a single step, using a fully aseptic process with no direct human intervention, in a fully controlled environment. Our lines are suitable for preservative-free products and operate in compliance with international GMP (EU, FDA, ANVISA, NMPA).

Our regulatory support covers all product categories developed or manufactured at our sites:

 

  • Medicinal products: new chemical drugs, generics/hybrids, orphan drugs, prescription-only or OTC products according to local guidelines (EMA, FDA, etc.), etc.
  • Medical devices: CE-certified (in accordance with MDR regulation 207/745) or intended for registration outside Europe based on CE marking.
  • Other health products: food supplements or other products, as applicable.

 

Each project benefits from tailored support adapted to the regulatory frameworks of the target markets.