The Dutch Oté Group has been marketing innovative contact lens care solutions for more than 30 years now. Oté has a strong market position both in the Netherlands and other countries developing, producing and marketing sterile solutions in plastic packaging.
Rest assured that with us, your products and formulations are in trusted hands. We can support and guide your product initiatives together with you from product design to final product. We are specialists in sterile aseptic solutions from 10 ml to 500 ml.
Flexibility and customisation are focal points in all aspects of our organisation. We will transform your product specifications into products with appropriate primary and secondary packaging, Meeting your logistical needs while seamlessly integrating with your internal organisation.
All products are manufactured in the Netherlands, with various disciplines and product lines for sterile filling of plastic packaging available to you. We are specialists in lens care, eye care and nasal care.
Oté Pharma is a reliable partner for high-quality medical device products such as contact lens solutions, eye drops, eye sprays and nose sprays. Oté Pharma’s mission is to continuously exceed customer expectations by offering exceptional quality, customised designs and personal service.
Oté Pharma continuously strives for innovation both for its products and its manufacturing processes. Oté Pharma therefore has a new, high-tech, cGMP production plant incorporating the most modern techniques available for production of pharmaceutical solutions and aseptic filling. The production plant is highly automated using a recipe-driven control system. This guarantees batch uniformity and quality at the highest pharmaceutical level.
The high-tech factory was designed, built and qualified in accordance with ISPE Pharmaceutical Engineering Guides. Process control is in accordance with ISA 88, GAMP and 21 CFR Part 11. The production plant therefore meets the most stringent pharmaceutical quality requirements in Europe and US (FDA).
All Oté Pharma products are certificated for marketing in various countries. All Oté Pharma products are certificated in accordance with the Medical Device Directive (MDD 93/42/EC) for access to the EU market and certificated according to ISO 13485 and NEN-EN-ISO 13485 quality management systems. Oté Pharma also operates according to other guidelines, e.g. NEN-ISO 13408-1.
Oté Pharma uses DEKRA Certification BV as its certification institute. DEKRA performs conformity assessments of Oté Pharma’s quality systems and products under Notified Body number CE0344.
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Oté Optics is the sales subsidiary of Oté. Its high-quality products and services target the worldwide optics market.
As THE specialist for optics businesses in the world of vision, Oté Optics looks forward to assisting you in a wide range of fields.
Vluchtoord 38
5406 XP Uden
The Netherlands
T +31 (0)413 - 25 77 06
F +31 (0)413 - 25 21 60
E export@ote.nl
IBAN NL89 RABO 0171 5864 09
Bank RABONL2U
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