The Italian manufacturing plant of Italfarmaco is located in the northern area of Milan.
The building, rising on an area of approximately 16,000 m2 with multiple blocks of about 10,000 m2, is totally devoted to the manufacturing of injectable preparations and oral solid products.
The manufacturing meets the highest international quality standards: Italfarmaco is authorized by the Italian Medicines Agency (AIFA) to the manufacturing of prefilled syringes, ampoules with terminal sterilization and the major oral solid forms both for clinical trials and business supplies. The manufacturing unit has been approved since 2004 by the American Agency Food and Drug Administration (FDA) for the manufacturing of prefilled syringes with an aseptic procedure.
The plant is among the most qualified in terms of manufacturing standards with annual manufacturing capacity for
80 million pre-filled syringes
50 million ampoules
1.5 billion tablets
Currently, Italfarmaco is the most important Italian manufacturer of pre-filled syringes, and among the few existing in Europe.
The Italfarmaco plant has been manufacturing pre-filled syringes since 1987 and over the years it has acquired a remarkable experience and skills thanks to the constant industrial investment in the most sophisticated and updated technologies.
In the last decade over one billion pre-filled syringes have been manufactured.
The manufacturing procedure of sterile solutions begins, among the first worldwide, as Cleaning and Sterilization in Place, and has been updated and consolidated over the years by employing all the most recent Hardware e Software technologies.
The inspection and packaging lines of syringes have been provided with the most advanced quality systems by an image picker front camera for the control and interception of potential defects of each single manufactured unit.
During the 2005 – 2015 decade, about 30 million euro were invested in the manufacturing plant, of which two thirds in new facilities or to replace existing ones and over 10 million euro employed only for the packaging lines of pre-filled syringes.
Investments are constant in order to maintain the highest quality standards.
All these technologies are also available for partner companies interested in the pre-filled syringe pharmaceutical form for research/development of new drugs or for industrial manufacturing. The manufacturing plant produces, in fact, also on behalf of many Italian and multinational companies.
The most recent certifications obtained from bodies and national and international regulatory authorities are:
Kenyan AuthorityGMPJune 2019
Lybian AuthorityGMPFebruary 2019
Russian AuthorityGMPJanuary 2019
USA FDAGMPSeptember 2018
Certiquality(ISO 45001)March 2021
CertiqualityScientif. Inform.February 2022
Certiquality(ISO 9001:2015 – QMS)March 2019
CETH (Belarus)GMPDecember 2015
TMMDA (Turkey)GMP & PAIFebruary 2015