History

SYNTHESIA, a. s. is a major European manufacturer active in the area of special chemicals, backed up by 100 years of history. It manufactures hundreds of products for customers in 70 countries all over the world. Synthesia employs around 1600 workers, its total annual sales in 2019 achieved approximately 161 million EUR.

From the medical point of view, Synthesia is an original Czech manufacturer of oxidized cellulose based haemostatic products, marketed under the registered trademark OKCEL®, which are used in biomedical segment with particular focus on professional surgery. OKCEL® product range is manufactured within the Business Unit Oxycellulose, which is a part of SBU Nitrocellulose, one of the strategic business units of Synthesia, a.s.

 

Main historical milestones
  1. 1920

    the history of our company begins with foundation of “Československá akciová továrna for explosive chemicals”

  2. 1923

    start of nitrocellulose production (energetic grades)

  3. 1925

    start of production of nitric and sulphuric acid

  4. 1939

    start of plant construction for the production of dyes and pharmaceuticals in Pardubice - Rybitví

  5. 1942

    start of API (Active Pharmaceutical Ingredients) production

  6. 1950

    start of nitrocellulose production (industrial grades)

  7. 1994

    Synthesia is transformed into a joint stock company

  8. 90´s

    gradual development of oxidized cellulose production

  9. 2004

    OKCEL® trademark assignment

  10. 2006

    new plant for production of oxidized cellulose and its derivatives

  11. 2009

    the only majority shareholder becomes AGROFERT HOLDING, a.s

  12. 2010

    assingment of CE mark for haemostatic products marketed under the brand OKCEL®
    launch of products OKCEL® H-T (standard knitted form) and OKCEL® H-D (heavy duty knitted form)

  13. 2012

    introduction of a non-woven absorbable haemostat OKCEL® F with layered structure

  14. 2020

    OKCEL® S introduction - new innovative strengthened cotton wool form of oxidized cellulose based haemostat

Quality and manufacturing

OKCEL® haemostats are classified as a class III medical device. They are CE marked by The Institute for testing and Certification, Inc., that confirmed compliance with all relevant EU standards regulating the production of medical devices.

Our  quality management system has been designed to maximize overall efficiency throughout the process chain as well as customer satisfaction and meet requirements of the international standard ISO 13485: 2016 and the European directive 93/42/EEC on medical devices. Our company has been certified by Lloyd´s Register Quality Assurance to ISO 13485:2016 Quality Management System Standard and by Bureau Veritas Certification Holding to ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018. Besides, Synthesia belongs to founder members of a programme called “RESPONSIBLE CARE”. After its successful ninth defense in August 2018, we acquired the right to use this logo until October 2022.

We put emphasis on the trained production staff, our employees keep in their mind that OKCEL® products, they manufacture, have been designed for human use and must be thus safe and effective. At all levels, we strive to simplify surgical procedures while improving patient care.

25

years of experience with haemostats

8

millions of surgical procedures

4

world continents

The BU Oxycellulose quality policy:

TOP management undertakes to manufacture safe and fully functional medical devices in accordance with applicable legal / regulatory requirements and to adhere to the surveillance and vigilance procedures relating to medical devices in order to ensure customer and end user satisfaction.

To achieve this goal, we have a team of skilled and competent staff, where each manager is responsible for enhancing quality in their department, while taking into account the quality improvement objectives not only in their area but throughout the company. Thus, each worker contributes to realizing the company's strategic goals.

In addition, TOP management undertakes to maintain the effectiveness of the quality management system using a process-based approach to setting goals for each quality management system area that is annually reviewed.

 

ISO 9001:2015
ISO 14001:201
ISO 45001:2018
ISO 13485:2016
EC 1023 No. 20 0029 QS/NB
EC 1023 No. 20 0030 QS/NB
Responsible Care

Cooperation

We are aware that research and development is a key area for further company progress. Annually, we invest higher and higher financial resources from net sales back into research projects, facilities and qualified human resources. We understand R&D as something that pushes us forward and creates a daily edge over our competition.

In order to maintain a high standard of product quality and end-users satisfaction in the introduction of new product innovations, Synthesia, a.s. cooperates closely with educational institutions in the chemical and technical fields, research institutes, surgeons and other medical professionals, including the following:

Association of Manufacturers and Suppliers of Medical Devices
University of Pardubice, Faculty of Chemical Technology
High School of Chemistry in Pardubice
Technical University of Liberec
University of Veterinary and Pharmaceutical Sciences in Brno
University of Chemistry and Technology in Prague
CEITEC - Central European Institute of Technology
VUOS a.s. (Research Institute of Organic Synthesis)
Nemocnice Pardubického kraje, a.s

 

Our cooperation with educational institutions takes many forms, including excursions, apprenticeships and assisting students in preparing their expert theses. We offer a TRAINEE programme designed specifically for university graduates.