Quality Management System

“Products of Indar – are the medications of high quality as confirmed by clinical trials that were specifically conducted to affirm the product quality. Cooperation between “Indar” and Oswaldo Cruz Foundation/ FIOCRUZ is on the rise, we are working at opportunities for new agreements, therefore regarding possibilities of signing similar agreements for medications’ manufacturing on the territory of Ukraine”.

Heine Filippe da Silva
Director of the Farmanguinhos Institute/ FIOCRUZ (FR Brazil)

The high quality of products and appropriate manufacturing standards of PrJSC “Indar” are approved by:

  • State inspection on quality control for medicinal products of the Ministry of Healthcare of Ukraine – License Provisions for production of medicinal products (2009);
  • Supreme Board of Drugs and Medical Appliances (SBDMA) under the Ministry of Public Health and Population of the Republic of Yemen – compliance of the production and of the quality assurance system of pharmaceutical products with the GMP rules. Recommendation for registration in the Republic of Yemen was issued (2009);
  • State inspection on quality control for medicinal products of the Ministry of Healthcare of Ukraine – the compliance of conditions of production of FPPs with the GMP rules. GMP Certificate was issued (2010);
  • Inspection of Ministry of Health of the Hashemite Kingdom of Jordan – compliance of the quality assurance system and technical status of production of recombinant human insulin substance and insulin medications with the GMP rules. Recommendation for registration in the Hashemite Kingdom of Jordan was issued (2011);
  • State Administration of Ukraine on Medicinal Products – compliance of License Provisions for business activities for industrial production of medicinal products (2011);
  • State Administration of Ukraine on Medicinal Products – industry-specific certification of Quality Control Laboratories (2012);
  • State Organisation “Ukrmetrteststandard” – compliance of the Quality Control Laboratories with State Metrological System requirements (2012);
  • State Administration of Ukraine on Medicinal Products – compliance of the Good manufacturing practice requirements. GMP certificate was issued (2012);
  • National Agency for Sanitary Surveillance (ANVISA) of Brazil. GMP certificate was issued (2013).