Laboratorios Roemmers reconoce que Internet es un medio de comunicación global; sin embargo, la industria farmacéutica está sujeta al marco regulatorio específico de cada país.
La sección Productos está exclusivamente destinada a satisfacer la necesidad de mayor información de los profesionales de la salud, para un uso adecuado de los medicamentos.
The Roemmers production facility for penicillin based antibiotics opened in 1992 and was recognized as a model plant. It was later expanded in 2007 to increase the storage areas, incorporate new technology and optimize industrial processes. These upgrades also reduced contamination risks while increasing its total productive capacity.
This facility produces products like AMOXIDAL, AMOXIDAL RESPIRATORIO, OPTAMOX, OPTAMOX DÚO as well as products for export according to national (ANMAT) and international standards (FDA – Food and Drug Administration - and EU – European Union).
This facility meets IRAM certification in GMP “Good Manufacturing Practices in Penicillinic Antibiotics for Oral Use” as well as ISO 14001 certification granted by DNV (Det Norske Veritas) for its environmental efficiency system and the GMP MERCOSUR Certification issued by the Argentine government as well as the equivalent certificate issued by INVIMA of Colombia.
This facility covers a 4,800-m2 area and has a production capacity of 35 million units per year. It operates with a staff of 90 highly qualified and trained people which include professionals, technicians and other employees.
All pharmaceutical services are controlled and supervised by a state-of-the-art Distributed Automated Control (DAC ) system. Production management is integrated by means of an SAP R/3 supervisory system which uses bar code methodology for pharmaceutical management during all its operations.
This facility features a modern three dimensional design which enables the facility to maximize in surface and volume usage with gravity-based vertical and horizontal flow of materials. Unitary operations (grinding, granulation, mixing) are performed in closed circuits with direct transference of powder from special stainless steel containers into production equipment for the various pharmaceutical shapes.
Production is carried out in high-speed equipment utilizing high-quality electronic control systems, an automatic monitoring system that controls all variables. All production is done in low humidity and controlled temperature conditions (22 to 28 % HRA: 20 to 25° C).
Key features of this facility include:
Samplings and analyses are performed throughout the production process to include raw materials, products in process and finished products thus ensuring the quality of the products that are released to market.