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Services / QUALITY ASSURANCE
API manufacturing quality assurance

QUALITY ASSURANCE

Inke has been successfully inspected by every major global authority for a wide
array of products (last US-FDA inspection in May 2016)
  • FDA inspected facilities approved since 2002
FDA inspected facilities approved since 2002
  • GMP certification by Health Authorities
GMP certification by Health Authorities
  • ISO 9001:2015
ISO 9001:2015
  • Full implementation of GMP
Full implementation of GMP
Patents in force on new synthetic processes

OUR RESULTS

· High-quality products, low impurity levels
· Successful internal/external audits
· High regulatory performance
· More than 85 granted patents in force on new synthetic processes, polymorphic forms and salts
Employees involved in quality assurance
Quality driven:
37% of our employees are involved
in quality assurance activities
Electronic Document Management System:
Open text · GMP training programme · Self-inspection programme