Quality, consistency and compliance are the basis of our Quality Management System and are enshrined in the stringent controls that we put in place throughout our supply chain.

Moreover, we have a fully vertically integrated manufacturing network, consisting of 7 main production facilities, plus several subsidiaries worldwide, which enable us to provide unmatched traceability and security in our supply chain.

As a group, we have the following UNI EN ISO Ceritifcates.

  • Quality Management
  • Environmental Management
  • Health & Safety At Work
  • Energy Certification

Regulatory compliance

Committed to the highest standards of quality and regulatory compliance.

Our long experience in the manufacturing process of bile acids derivates and our extensive knowledge in managing specific issues related to animal derived products, allows us to maintain industry-leading quality & safety standards at each of our sites around the world.

ICE Pharma Quality Team is a global organisation that ensures the harmonisation of standards and procedures. Internal corporate audits, customer audits and regulatory agency audits are performed on a very regular basis.

Safety Assurance

We ensure the safety of our products of animal origin through the use of suppliers authorised by the national health authorities and through our robust manufacturing processes.

Our bile only comes from qualified sources and the material is accompanied by veterinary certificates issued by the competent authorities declaring the origin of the animals and that they are disease free. Our procedures ensure that the origin of the raw materials is traced throughout our whole production process affording our customers total confidence in the final product.

Although bile from bovine origins is an auto-immunizing substrate our procesess have been designed to guarantee irreversible disruption and denaturation of all viral structures.

We support our customers with regulatory filings in all the main markets

The group is certified by the main Regulatory Agencies worldwide and can support its customers in the registration of their products at international level.

We are authorized by the following Health Authorities.

  • Italy
  • USA
  • Europe
  • Japan
  • New Zealand
  • Canada
  • India
  • South Korea
  • Brazil
  • Russia


Strengths of our quality system

  • Experienced

    We have decades of experience in the manufacturing process of bile acids and their derivatives.

  • Accredited

    Our sites are regularly inspected and authorised by the main Health Authorities worldwide, including AIFA, FDA and the PMDA.

  • Harmonised

    ICE Quality team is global and ensures the harmonisation of quality standards across all manufacturing locations.

  • Fully integrated

    From bile collection until the manufacture of API or FDF all production steps are under ICE’s quality control and supervision.