Cambrex Corp. (East Rutherford, N.J.; www.cambrex.com) the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), announced the validation and ISO certification of a new pilot plant at its manufacturing and R&D site in Paullo (Milan), Italy.
The cGMP plant, which can produce batch sizes from 1 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.
“We currently have a product portfolio comprising over 70 generic APIs, which are manufactured under cGMP, for the global generic pharmaceutical industry,” commented Aldo Magnini, Managing Director, Cambrex Milan. “We have invested in the pilot plant to expand our small-scale volume offering for customers worldwide and to give us greater speed, flexibility and capacity in this market space.”
The new facility 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.