Operon S.A.

Camino del Plano 19
50410 Cuarte de Huerva / Zaragoza
Spain

Phone: +34 976 503597
Fax: +34 976 503531

Operon. Immuno & molecular diagnostics


sales@operon.es

Manufacturers
OEM
Service

Company Contacts
Department/ Name Address

General Manager / Tomas Toribio t.toribio@operon.es

Sales&Mkt Manager/Francisco J. Munoz f.munoz@operon.es

Sales&Mkt/Isabel Ruiz i.ruiz@operon.es

Sales&Mkt/Paula Las Heras p.lasheras@operon.es
Company Figures
Number of employees 50-99
Sales volume 1-9 Mio US $
Export content > 75%
Year of foundation 1973
Area of business Diagnostics

Company Profile

Operon: your right decision for any IVD challenge
HISTORY
Operon S.A. is a Spanish company active since 1973, focusing its activity on research, development, manufacturing and sales of in vitro diagnostic products ( IVD ). The Company’s target was to satisfy the needs of the Spanish market. In 1982 Operon started its international sales operation.

COMPANY STRATEGY
All the immunological IVD products offered by Operon have been developed and are produced in its own facilities. The products are sold in many countries around the world with own brand name, on an OEM basis or in bulk.

HUMAN RESOURCES
Operon employs 40 people, 14 of them in R&D.

PHYSICAL RESOURCES
2000 square meters (own) laboratories and manufacturing facilities located close to Zaragoza (Spain).

TECHNOLOGIES
Operon has large experience in the following technologies:

– direct latex agglutination reagents.

– immunocromatographic assays (one-step tests).

– development and production of monoclonal antibodies.

– production of recombinant proteins.

Its principal products are IVD rapid tests for Clinical, Veterinary and Food Diagnostics based on the above mentioned technologies.

QUALITY STANDARDS
Our quality systems meet the most important standards focusing our efforts to manufacture our products with the highest quality and safety.

The Quality Management System of OPERON S.A. has been approved, since July 1998, by Lloyd’s Register Quality Assurance to the following Standards : ISO 9001:2000 and UNE EN ISO 9001:2000. The system is applicable to the Development and Production of “in vitro” diagnostic products.

OPERON S.A. has also been certificate in UNE-EN-ISO 13485:2001 corresponding to the internationally known GMP.

Moreover, we comply with the requirements of the European “in vitro” Diagnostic Directive 98/79/EC or its Spanish transposition Real Decreto 1662/2000, which allows the CE labelling of our products.

AGREEMENTS
Operon is seeking distributors world-wide. The company is also open to consider co-operations in different countries which could imply development of new tests, technology transfer and joint ventures.

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