Manufacturing
Manufacturing
At Jazz, we are developing life-changing medicines and bringing them to people with unaddressed needs around the world, and we take this responsibility very seriously. As a global biopharmaceutical company, Jazz employees continuously work to ensure that our medicines are manufactured to the highest quality, safety and efficacy standards.
Our Teams
Our manufacturing and technical operations teams play a vital role at every point of the product lifecycle, encompassing formulation research, process development, manufacturing and global supply chain management to consistently deliver the highest quality medicines to patients. Our teams take a multi-faceted approach toward operational excellence, questioning even the most established processes and procedures with the goal of finding better ways to achieve our goals.
Jazz is committed to providing a safe and healthy work environment for employees, and to preserving and protecting the environment.
Health and Safety
Health and safety are top priorities for Jazz. We aim to avoid accidents and to promote health and well-being for all employees.
To create and sustain a safe workplace where health is protected, Jazz implements proper risk evaluation, education and training of employees, use of appropriate personal protective equipment, and compliance with relevant national and international health and safety standards.
Environment
Jazz pursues sustainable development through careful use of resources with minimal environmental impact.
We continuously strive to reduce consumption of materials and energy, and to cut the quantities of waste and emissions generated by our facilities. Wherever possible, we strictly separate and recycle waste and always correctly dispose of any toxic, hazardous and biological materials.
Manufacturing Sites
Villa Guardia, Italy (Gentium S.r.I.)
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.
Environmental Standards
- EHS Policy
- Environmental Statement
- EMAS Registration Certificate
- ISO 14001 Certificate
- ISO 45001 Certificate
Ethical Standards
Please refer to the contact details below if you have any questions regarding our API manufacturing capabilities.
Contact Us
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
Athlone, Ireland (Jazz Pharmaceuticals Ireland Limited)
The Jazz Pharmaceuticals Ireland Manufacturing and Development facility is located in Monksland, west of Athlone Town, in an area zoned for industrial development by Roscommon County Council, just over 70 miles from our Dublin headquarters. Opened in 2016, it was the first directly owned and operated Jazz facility capable of developing, manufacturing and packaging drug products. The site is approved by multiple regulatory authorities and manufactures products for clinical and commercial use.
The site prides itself on its excellent safety and compliance record. Its efficient performance to deliver products to patients is done with an agile, flexible and high-performing team committed to the pursuit of excellence.
For the project execution and opening of the Athlone facility, Jazz was named winner of one of the 2017 International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA). Jazz is honored that the Athlone facility has been recognized as one of the innovative sites setting the standard in the industry, and we are committed to continued quality, safety, efficiency and technological advancement.
Contact Us
Monksland, Co. Roscommon,
Ireland
N37 AX84
Tel. +35 31 637 2022 or +353-1 634 7800