Development and manufacturing for respiratory treatments

Chronic respiratory diseases (asthma, COPD, cystic fibrosis) require safe, sterile, and optimized formulations for inhaled administration. There is increasing demand for more tolerable, preservative-free solutions adapted to current nebulization practices.

Unither has developed unique expertise in sterile forms for inhalation, particularly through global-scale mastery of Blow-Fill-Seal (BFS). This closed and aseptic technology allows the production of sterile single doses that are perfectly suited to nebulization, offering high stability and optimal tolerance.

We also support laboratories in the development of multi-dose respiratory solutions and suspensions, with or without preservatives, adapted to international regulatory requirements (EMA, FDA, ANVISA, NMPA).

The respiratory formats we can produce for you

Licensing-out – Our turnkey solutions and products (Respiratory)

Unither offers a portfolio of respiratory products ready for registration, covering the main market needs:

• Inhalation and rhinology solutions (isotonic and hypertonic saline solutions, seawater) in sterile single-dose form

• Nasal sprays and throat sprays (medical devices and medicines)

• Liquid “cough & cold” sticks (single oral doses, with or without preservatives)

• Syrups and drinkable solutions for the treatment of respiratory symptoms

• Formulations incorporating Carragelose®

These dossiers enable accelerated market launch, with proven formulas, comprehensive stability data, and international regulatory compliance.

 Table: Licensing-out – Our turnkey solutions and products (Respiratory)
 Product Volume Respiratory Indication Format / Technology Status
Hypertonic Saline Solution 3%, 6%, 7% 4 mL Inhalation BFS unit dose MD
Isotonic Saline Solution 0.9% 2,5 mL / 5 mL Inhalation BFS unit dose MD IIb
Isotonic Saline Solution 0.9% 5 mL Rhinology BFS unit dose MD
Multi-purpose Isotonic Solution 0.9% 5 mL Inhalation BFS unit dose MD IIa
Seawater 5 mL Rhinology BFS unit dose MD
Dextromethorphan (preservative-free) 5 mL Cough and cold Stick-pack Drug
Oxomemazine (sugar-free) 10 mL Cough and cold Stick-pack Drug
Paracetamol / Vitamin C / Pheniramine maleate 1,483 g Cough and cold Stick-pack Drug
Ambroxol hydrochloride 5 mL Cough and cold Stick-pack Drug
Ambroxol hydrochloride (sugar-free) 150 mL Cough and cold Bottle Drug
Dextromethorphan (preservative-free) 125 mL Cough and cold Bottle Drug
Carragelose Nasal Spray 20 mL Cough and cold Spray MD IIa
Carragelose Throat Spray 20 mL Cough and cold Spray MD IIa

Our proprietary technologies

Carragelose

Carragelose

We integrate innovative technologies into our respiratory range. For example, Carragelose (recently acquired) is a patented molecule that forms a protective film on mucous membranes, blocking the interaction of viruses and allergens with the nose and throat. This technology is utilized in antiviral/antiallergic nasal and oral sprays. Other platforms (Sol-Gel, micro-beads, etc.) are also being developed for specific respiratory applications, leveraging our multi-area therapeutic experience.

Learn more

Why trust us?

30+ years of experience in OTC respiratory liquid formats

4 continents: Europe, USA, Brazil, China

5 billion single doses/year BFS Leader

Do you have a project?

Talk to our experts

Simonne FARINA

OTC Director

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Manufacturing

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Development

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Regulatory Support

Comprehensive regulatory support, from pharmaceutical development to CTD/eCTD document submission.

Got questions? - Consult our FAQ

Unither Pharmaceuticals is the world leader in Blow-Fill-Seal (BFS) technology and a specialist in sterile liquid formats. Our presence in Europe, North and South America, and Asia ensures volume security, supply continuity, and proximity to your markets.

With robust cGMP processes, expertise in international regulations, and an efficient co-development model, Unither accelerates and supports your projects, from formulation to commercial manufacturing.

Unither offers several flexible collaboration models, tailored to the needs of pharmaceutical industry players, from innovative start-ups to large international pharmaceutical companies.

Collaboration models tailored to your projects

Depending on your objectives, Unither offers different types of partnerships:

  • Contract manufacturing: production of clinical and commercial batches at industrial scale
  • Licensing-out: turnkey product solutions designed to meet patient and market needs
  • Co-development: close collaboration to design, develop, and industrialize a new product