Altergon Italia
The Sodium hyaluronate manufacturing plant (designed by Altergon Italia following the principles of Quality and Safety by Design), started the bulk production in 2011. The state-of-the-art facility produces high quality hyaluronic acid suitable for the pharmaceutical, medical and dermocosmetic industries. Altergon Sodium Hyaluronate Powder complies with the main standards, such as ICH Q7 and cGMP Eudralex volume IV part II, and the well qualified staff ensures the consistent production of highly purified and very safe sodium hyaluronate. The company is also proud of its integrated quality policy which guarantees, on the one hand, minimal ecological impact due to the use of non-polluting construction materials, TSE/BSE/virus free raw materials, the control of waste and effluents and on the other hand, protection of personal health and security.
The production plant is entirely dedicated to the production of highly purified, ultrapure sodium hyaluronate: no product cross-contamination issues. The equipment and the process were designed according to ISPE guidelines (Active Pharmaceutical Ingredients and Biopharmaceuticals manufacturing facilities): no external contamination possible (the entire cycle is closed). A robust quality system, a highly qualified and motivated staff, an exhaustive validation and calibration policy (more than 1,000 calibrations made every year) ensure that all suppliers, components, process steps and equipment are validated, qualified and monitored according to current rules and cGMP requirements.
Altergon Injectable Hyaluronate
Ultrapure Plus Standard
Endotoxins
≤5 EU/GRAM) ≤0.005 I.U/mg
Endotoxins
≤500 EU/GRAM) ≤0.5 I.U/mg
Molecular Weight range:
40-3,000 kDa
Molecular Weight range:
40-3,000 kDa
Molecular Weight range:
40-3,000 kDa
Intrinsic Viscosity:
0.2-3.2 m3/Kg
Intrinsic Viscosity:
0.2-3.2 m3/Kg
Intrinsic Viscosity:
0.2-3.2 m3/Kg
Intended use:

  • Intra-articular administration
  • Intra-ocular administration
  • For Cross-link
  • For Viscosupplements and Viscoelastics
Intended use:

  • Parenteral administration
  • Eye drops
  • Intravesical application
  • Aerosol
Intended use:

  • Functional Food
  • External Medicine