Production
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.
- Biphosphonates.
- Friedel-Craft reactions.
- Hormone synthesis.
- Particle size reduction by micronizing.
Main capabilities:
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.
Production Facilities:
- 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.