Certification

Highest standards

ASM works strictly to the following standards: GMP, cGMP as well as ISO 9001 : 2015, ISO 13485 : 2016 and ISO 22716 : 2007. ASM can also offer services for CE registration for medical devices. ASM was audited in May 2015 by FDA and received approval i.e. FDA Registration (FEI-No. 3005439256).

ASM has been licensed to manufacture the following medicinal products:

  • pharmaceuticals and medicinal products in liquid form
  • semi-solid pharmaceutical preparations
  • sprays (aerosols)
  • bulk manufacture
  • pharmaceutical products for clinical trials
  • products involving highly active or allergenic active ingredients

 Processing of the following products is not included

  • aseptically manufactured products
  • biological products (immunological medicinal products, medicinal products involving living organisms)

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