Our manufacturing facilities and manufacturing systems comply with the highest standards of cGMP, which is guaranteed by:
- A continuous improvement.policy.
- A staff of operators, technicians and professionals highly trained, with a long expertise and background in the industry.
- The conviction that quality is made by operators.
- The highest proud for the well done job.
- The support of state-of-the-art equipment and facilities and a well designed system of documentation and procedures.
Processes – areas of expertise:
Our organization has developed the following areas of expertise:
- Grignard reactions.
- Borane reductions.
- Friedel-Craft reactions.
- Hormone synthesis.
- Particle size reduction by micronizing.
The total reactor capacity is about 10 m3, including glass lined, stainless steel and glass reactors, some of them with single fluid heating and cooling systems, in a temperature range between -15 to 150ºC and pressures between 20 mbar to 6 bar.
Isolation, drying, milling and packaging of final products are performed in class ISO 8 (M6.5) areas.
- General purposed reactors area (800 m²).
- Solids handling area class ISO 8 (M6.5), pharma designed (300 m²).
- Hormones production segregated facilities, class ISO 8 (M6.5).
- Production area for injectable forms, class ISO 7 (M5.5), pharma designed.
- Warehouses for solid raw materials, intermediates and, with temperature control, for finished products. (422 m²).
- Dispensing area class ISO 7 (M5.5).
- Sampling area class ISO 7 (M5.5)
- Warehouses for flammable solvents.