Regulatory Status

Production to International Standards

Boehringer Ingelheim's biopharmaceutical production is compliant with all relevant national and international standards. Our products are developed for worldwide registration. We maintain approvals in more than 120 countries.

The highest level of compliance

The highest level of complianceAll our production plants operate under cGMP and are approved by the competent European, US, Canadian and Japanese authorities. In addition to the requirements we adhere to, all our facilities are subject to regular scrutiny by the health authorities, consultants and quality assurance units of our partners. Our company's policy is to maintain the highest level of compliance.

Our multi-product manufacturing facilities at Biberach (Germany) and Vienna (Austria) are inspected by the European Medicines Evaluation Agency (EMEA), the Food and Drug Administration (FDA) and Health Canada. They hold the licence for numerous products. All plants meet the requirements of the World Health Organization and the Pharmaceutical Inspection Convention.