Manufacturing sites in Italy

Innovation and technology, the Italian way

The IBSA Group is present in five different continents and over 80 countries, including Italy, where it has manufacturing sites in Cassina De’ Pecchi and Lodi.

In addition to embodying Italian quality and excellence, our two Italian plants also express the Group’s potential in terms of innovative know-how and expertise. This is demonstrated by the patented hi-tech production lines that make IBSA one of the few European players that manufactures both pharmaceutical and nutraceutical products.

THE LODI PLANT, LOMBARDY, ITALY

Over the years, the Lodi plant, which was purchased by the Swiss Group Institute Biochimique SA in 2001, has seen a complete and radical revamping of the existing production areas and the construction of a new state-of-the-art manufacturing facility equipped with cutting-edge production lines for the development of novel delivery systems for medicinal products, medical devices and food supplements.

The plant covers a total surface area of 12,000 m², housing 12 production departments, the warehouse and starting material sampling areas, the dispensing department for the preparation of work orders, the Research & Development labs, the chemistry and microbiology Quality Control labs, and the Regulatory Affairs, Quality Assurance, Production, Engineering and Maintenance offices.
The pharmaceutical production area and the starting materials warehouse occupy 5,500 m², whereas the food supplement manufacturing area and its dedicated warehouse occupy a surface area of 1,000 m².
The plant is staffed by a workforce of 185 resources.

The nearby Lodi 2 area is home to the Management Offices and the packaging materials and finished product warehouse. This warehouse is currently being extended and once the construction work is complete it will occupy an area of over 2,500 m².

The plant manufactures products for injection, both in sterile conditions and terminally sterilised, in conventional ampoules and pre-filled syringes, preparations for topical use (creams, gels and solutions) in BoV (Bags on valves) and soft capsules (soft gel).

The plant’s production lines, which in 2019 manufactured approximately 24.5 million pieces, boast state-of-the-art technology and are environmentally sustainable.

The hefty investments made for the modernisation of the industrial plant and processing lines have made it possible to achieve production plants with high efficiency standards.

The annual production capacity of the various product ranges is as follows:

• Conventional ampoules: 12 million units
• Pressurised cans (BOV): 7.5 million units
• Aluminium tubes: 2 million units
• Pre-filled syringes: 19 million units
• Soft capsules - pharma line: 160 million units
• Soft capsules - nutraceutical line: 130 million units

The pharmaceutical products manufactured at the Lodi 1 plant serve the IBSA group and supply a number of markets including, in addition to Italy, Switzerland, Great Britain, Hungary, Slovakia, Czech Republic, Poland, Greece, Spain, Scandinavian countries, Russia, Egypt, Turkey, United Arab Emirates, USA, Brazil and Korea.

AUTHORISATIONS:

• Italian Medicines Agency (AIFA) (for the pharmaceutical products mentioned - two-yearly inspections)
• GMP Certificate
• FDA Certificate (for certain specific products)
• Quality System: Certified in accordance with ISO 9001: 2015 and ISO 13485 2016 (IMQ)
• Manufacture of Medical Devices: subject to regular inspections by the various European Notified Bodies
• Manufacture of nutraceuticals: authorised by the Ministry of Health and supervised by the Local Health Service.

THE CASSINA DE’ PECCHI PLANT, LOMBARDY, ITALY

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The Cassina De’ Pecchi plant, which was founded in 1994 and purchased by IBSA in 2010, boasts 20 years’ experience in the production of patches containing diclofenac, fentanyl, nitro-glycerine and piroxicam.

In 2017, it started manufacturing sildenafil in orodispersible film (ODF) and in 2019 it commenced the production of food supplements, again in orodispersible film form.

The productions with a higher technological and innovative content manufactured at the plant include orodispersible film (ODF). A patented technology has allowed IBSA to become one of the few companies in Europe to manufacture both pharmaceutical and nutraceutical products.

A second field of production with a high technological and innovation content are the medicated transdermal patches based on drug-in-adhesive technology that allows controlled release of the medicinal product.

The plant covers a total surface area of 10,520 m², including research and development laboratories, a dedicated quality control department and offices. The production areas and warehouse occupy an area of 5,450 m² and utilities 3,404 m². More than 70 people work there.

Production focuses on the following technologies and pharmaceutical forms:

• Medicated patches for topical and transdermal administration
• Patches with natural active ingredients for cosmetic applications and medical devices
• Basic plasters and special wound dressings
• Orodispersible film (ODF)

Annual productive capacity for the various pharmaceutical forms is:

• Topical patches:
  • transdermal patches: 20 million units
  • orodispersible film: 16 million units
• Dressings: 25 million units
• Nutraceuticals in ODF: 15 million units

The products manufactured at the Cassina plant serve both the IBSA Group and directly supply a number of markets, including, in addition to Italy, France, England, Hungary, Slovakia, Czech Republic, Spain, the Baltic Republics, Scandinavian countries, the EMEA area and South America.

AUTHORISATIONS:

• The Quality System is certified in accordance with ISO 9001: 2015 and ISO 13485 2016 (IMQ)
• AIFA authorisation and GMP compliance certificate (Directive 2001/83/EC and Legislative Decree 219/2006) for:
  • production, primary and secondary packaging, control of non-sterile medicinal products (“impregnated matrices”, transdermal patches, orodispersible film)
  • manufacturing of non-sterile investigational medicinal products (“impregnated matrices”, transdermal patches, orodispersible film)
• Authorisation for psychoactive and psychotropic substances (Italian Presidential Decree 309 of 09/10/1990)