Cambrex Opens New Pilot Plant at Its Milan, Italy Site
October 03 2016 - 3:00AM
Cambrex Corporation (NYSE:CBM), the leading manufacturer of small
molecule innovator and generic Active Pharmaceutical Ingredients
(APIs), today 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.
“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.
About CambrexCambrex
Corporation is an innovative life sciences company that provides
products, services and technologies to accelerate the development
and commercialization of small molecule therapeutics. The
Company offers Active Pharmaceutical Ingredients (APIs), advanced
intermediates and enhanced drug delivery products for branded and
generic pharmaceuticals. Development and manufacturing capabilities
include enzymatic biotransformations, high potency APIs, high
energy chemical synthesis and controlled substances. For more
information, please visit www.cambrex.com.
Contact: Alex Maw
Director, Marketing and Communications
Phone: +44 7803 443 155
Email: alex.maw@cambrex.com
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