Gentium S.r.l. is a Jazz Pharmaceuticals company. Located in Villa Guardia, Italy, Gentium’s manufacturing plant and QC laboratories supply active pharmaceutical ingredients (API) to Jazz and various other pharmaceutical companies around the world. Medical and sales support for Jazz’s products in Italy is provided by Jazz Healthcare Italy S.r.l.
With our state-of-the-art manufacturing facility, Gentium sets a new standard for the manufacturing and control of active ingredients extracted from biological tissues and has over 40 years of experience in this field. The team has developed efficient manufacturing methods and controls in accordance with current Good Manufacturing Practices (GMP) assuring the drug’s potency, identity, strength, quality and purity.
In addition, Gentium capability includes QC testing, stability and batch release of biological medicinal products. Gentium is inspected by the major Regulatory Agencies, including AIFA, US-FDA, PMDA and ANVISA.
Our production technology and quality control are continuously aligned with the latest technological standards and international quality requirements. We work hard to ensure that for each batch of drug product or drug substance that is manufactured, a robust and documented traceability chain exists. This allows us, our customers and the authorities to have the ability to identify all of the sources for every batch that is made.
As an Eco-Management and Audit Scheme (EMAS) Registered Organization, we have published the following environmental policies and certifications which can be accessed by clicking on each of the links below.
Please refer to the contact details below if you have any questions regarding our API manufacturing capabilities.
Gentium S.r.l.
Piazza XX Settembre 2
22079 Villa Guardia (CO)
Italy
Company Registered in Como, No. 240386
Tax Code and VAT Registration number: 02098100130
Tel. +39 031 5373 200
Fax +39 031 5373 784
E-mail: Gentium@jazzpharma.com
