Certificates and approvals

Our company and our products are certified and approved according to international quality standards.

Our Mesalazine is registered in more than 90 countries. We are therefore ideally placed to support customers with our specialist knowledge of the registration processes in numerous countries. In our experience, this saves our customers a lot of time and energy when they enter a new market or register a new product.

In short:

  • Our Mesalazine meets Ph.Eur. and USP specifications
  • Our Mesalazine has been approved in more than 90 countries, including the EU, the US, Canada, Japan, Australia and  Russia
  • We hold a CEP from EDQM
  • We are US FDA approved
  • Our production meets the requirments of cGMP and we hold a GMP certificate from the Danish Health and Medicines Authority

 


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