Oté Pharma
Manufacturer and contract producer of sterile ophthalmic and eye-care products. Operates cleanroom sterile-filling facilities and automated production lines to produce contact lens solutions, eye drops, ocular sprays and related consumables. Provides private-label and OEM services, product design and regulatory support, and holds certifications for medical-device quality systems used for EU and international markets.
Industries
Nr. of Employees
small (1-50)
Oté Pharma
Products
All-in-one contact-lens solutions (lubricating and disinfecting)
Multipurpose solutions for soft and rigid lenses combining cleaning, disinfection, protein removal, rinsing, storage and rewetting functions; variants include hyaluronate or provitamin B5 and PHMB preservatives.
Hydrogen-peroxide disinfection systems
3% hydrogen-peroxide based disinfection systems with neutralization components for soft contact lenses.
Buffered preservative-free saline solutions
Buffered, preservative-free saline solutions for rinsing and storing contact lenses and ocular surfaces.
Eye drops and ocular sprays (preservative-free formulations)
Preservative-free lubricating eye drops and eyelid sprays based on hyaluronate or provitamin B5 for symptomatic relief of dry or irritated eyes.
Eyelid and instrument cleaning wipes
Single-use cleaning wipes for eyelid hygiene and for hygienic cleaning of instruments and small surfaces.
Enzymatic cleaning tablets and abrasive cleaners
Enzymatic cleaning tablets and abrasive cleaners for intensive removal of deposits on contact lenses, especially for rigid lenses and heavy soiling.
All-in-one contact-lens solutions (lubricating and disinfecting)
Multipurpose solutions for soft and rigid lenses combining cleaning, disinfection, protein removal, rinsing, storage and rewetting functions; variants include hyaluronate or provitamin B5 and PHMB preservatives.
Hydrogen-peroxide disinfection systems
3% hydrogen-peroxide based disinfection systems with neutralization components for soft contact lenses.
Buffered preservative-free saline solutions
Buffered, preservative-free saline solutions for rinsing and storing contact lenses and ocular surfaces.
Eye drops and ocular sprays (preservative-free formulations)
Preservative-free lubricating eye drops and eyelid sprays based on hyaluronate or provitamin B5 for symptomatic relief of dry or irritated eyes.
Eyelid and instrument cleaning wipes
Single-use cleaning wipes for eyelid hygiene and for hygienic cleaning of instruments and small surfaces.
Enzymatic cleaning tablets and abrasive cleaners
Enzymatic cleaning tablets and abrasive cleaners for intensive removal of deposits on contact lenses, especially for rigid lenses and heavy soiling.
Services
End-to-end private-label service covering product selection, formulation support, packaging, labeling and design for eye-care assortments.
Contract production and filling of sterile liquids in plastic packaging, including eye drops, sprays and certain other sterile product groups.
Support for product concept, formulation development, product sheets and labeling to prepare market-ready ophthalmic products.
Support for quality systems, documentation and conformity assessment to enable market access under medical-device regulations and ISO standards.
End-to-end private-label service covering product selection, formulation support, packaging, labeling and design for eye-care assortments.
Contract production and filling of sterile liquids in plastic packaging, including eye drops, sprays and certain other sterile product groups.
Support for product concept, formulation development, product sheets and labeling to prepare market-ready ophthalmic products.
Support for quality systems, documentation and conformity assessment to enable market access under medical-device regulations and ISO standards.
Expertise Areas
- Sterile ophthalmic manufacturing
- Private-label and OEM contract manufacturing
- Ophthalmic formulation development
- Quality management for medical devices (ISO 13485)
Key Technologies
- Cleanroom sterile filling
- Automated filling and packaging lines
- Filter-based sterile filling for preservative-free formulations
- Hydrogen peroxide contact-lens disinfection systems
News & Updates
Facility audit by the US FDA assessing GMP-compliant manufacturing; inspection was successful with no Form 483s issued.
Operational changes to increase capacity including adding weekend production shifts and other capacity measures.
Reporting on improved production efficiency following installation of a new buffer tank.
Quality-management system certified to ISO 13485 and products assessed for conformity to EU medical-device requirements; conformity assessment performed by a Notified Body.
Facility audit by the US FDA assessing GMP-compliant manufacturing; inspection was successful with no Form 483s issued.
Operational changes to increase capacity including adding weekend production shifts and other capacity measures.
Reporting on improved production efficiency following installation of a new buffer tank.
Quality-management system certified to ISO 13485 and products assessed for conformity to EU medical-device requirements; conformity assessment performed by a Notified Body.