At Unither Pharmaceuticals, we leverage our industrial and regulatory expertise to serve a wide range of therapeutic areas, extending far beyond our traditional fields. Thanks to our aseptic technologies, innovation capabilities, and agile CDMO model, we support our partners in high-potential markets: wellness, food supplements, OTC, medical devices, veterinary care, etc.
Development and manufacturing for all treatments
Cutting-edge technologies for stand-out products
Ready-to-use solutions to expand your portfolio
Out-licensing
Our product portfolio includes turnkey formulas available for licensing, with marketing authorization or CE marking, ready for registration and commercialization. The indications covered are varied: cough and cold, fever and pain (adults and children), gastroenterology, oral health, and addiction.
Content type: Solution
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Content type: Solution
Solution
Content type: Solution
Solution
Why trust us?
4 continents
global presence
+100 countries
where our customers' products are distributed
5 billion doses/year production capacity
world leader in BFS
Do you have a project?
Talk to our experts!
Natalia SERVOL
Ophthalmic Division Director
Ni ZENG
Head of Co-Development
Simonne FARINA
OTC Director
End-to-end support from the initial phases: from concept to product
Development
Formulation and analytical development, manufacture of clinical batches, stability studies, and expertise in ophthalmic development.
Manufacturing
From technology transfer to industrial manufacturing, from small clinical batches to commercial volumes.
Regulatory Support
Comprehensive regulatory support, from pharmaceutical development to CTD/eCTD document submission.
Co-Development Program
An innovative partnership to reduce time-to-market for your products.
Got questions? - Consult our FAQ
Which therapeutic areas is BFS used in?
Blow-Fill-Seal can be used in several therapeutic areas:
- Ophthalmology: eye drops for glaucoma, dry eye, infections, or post-surgery treatments.
- ENT: physiological saline solutions for nasal and pediatric hygiene.
- Respiratory care: nebulization solutions for asthma, COPD, or cystic fibrosis.
- Injectables
BFS allows the production of sterile preservative-free single doses, thus improving safety during delivery and facilitating compliance among patients suffering from these conditions.
Are regulatory services included or are they extra?
Yes. Certain regulatory support is always included during development and manufacturing projects. In some cases, we also offer additional regulatory services:
- Registration strategy,
- Full preparation of CMC modules (IMPD/IND, CTD/eCTD)
- Variation management and inspection support.
Can Unither provide CMC regulatory support (dossier preparation, variations, and exchanges with authorities)?
Yes. Our regulatory teams can assist with the preparation and updating of CMC modules, including drafting dossiers, managing variations, and handling exchanges with health authorities (EMA, FDA, etc.).
We work closely with technical teams to ensure compliance with ICH and GMP requirements and have extensive experience in orphan products and projects with stringent regulatory requirements.