Inspected Quality

mcko delivers best quality in compliance with cGMP (current Good Manufacturing Practice)

mcko passed successfully many relevant inspections and audits:

• mcko is approved by the FDA (Food and Drug Administration) USA
• mcko is GMP certified in Nov 2007 and September 2010 according to Art 111 (5) of Directive 2001/83/EC.
• The Minister of the MHLW, Japan certified that mcko is an accredited foreign manufacturer according to the provision of Article 3.3 of the Pharmaceutical Affairs Law.
• mcko has in addition been successfully audited by many national and foreign customers.