Date: 2016-10-03
Type of information: Opening of new premises
Compound: manufacturing and R&D site in Paullo (MI), Italy
Company: Cambrex (USA - NJ)
Therapeutic area: Technology - Services
Type agreement: opening of new premises
Action mechanism:
Disease:
Details:
- • On October 3, 2016, Cambrex announced the validation and ISO certification of a new pilot plant at its state-of-the-art manufacturing and R&D site in Paullo (MI), Italy. The cGMP plant, which can produce batch sizes from 1kg to 15kg, was constructed in order to meet customer demand for small-scale API volumes, both for validation to support a DMF filing for Abbreviated New Drug Applications or generic registrations, and for API supply to niche markets, including ophthalmic drugs.
- The new facility will also provide custom manufacturing of NCEs and intermediates for early stage drug development and clinical trials. It is equipped with a hydrogenator that can operate at 30 Bar and two separate lines of 150 liter glass lined and stainless steel reactors. ISO 8 classified, the plant is also equipped with a static dryer, milling and micronization capabilities.
- Cambrex plans a further upgrade of the pilot plant in 2017 to support production of Class 3/4 high potency products.
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Is general: Yes
