The IBI production plant, certified by the AIFA and FDA regulatory authorities, consists of various production departments, which can manufacture sterile products (solutions or freeze-dried powder or aseptic doses) and non-sterile products (oral and topical) following cGMPs. Among the sterile products IBI stands out in the production of injectable β-lactam drugs, and has a whole segregated area devoted to this. Furthermore, it is also authorized to manufacture biological finished products and/or products for clinical trials.
Thanks to the wide use of single-use systems the production operations are streamlined and project planning is reduced, cutting the time taken to arrive at the sales phase.
PARENTERAL DOSAGE FORMS (solutions and freeze-dried powders)
Dosing for vials that go from 2 to 100 ml and syringes that go from 0.5 to 5 ml can be performed in a laminar flow hood, protected by C-RABS. The company also has a dosage line dedicated to phase 1 experimental batches.
ORAL AND TOPICAL DOSAGE FORMS
- Tablets, capsules, sachets, syrups (solutions, suspensions and emulsions)
DEPARTMENTS DEDICATED TO β-LACTAM PRODUCTS
- Production of sterile penicillin using crystallization and freeze-drying methods in completely segregated and automated departments (150,000 kg/year)
- Aseptic dosage of sterile powder in vials (from 250 mg to 40 g / vial)
- Approx. 45 million vial/year
- Automatic visual inspection control
EXPERIMENTAL MEDICINE PRODUCTION
- Formulations for pre-clinical and clinical trials
- Injectable and oral finished products (also biotechnological)
- Special dosage line for products for phase 1 and 2 trials