Vertically integrated pharmaceutical
company in the Baltic States

cGMP Compliant operations

All assignments concerning APIs are managed under strict cGMP requirements.

The supply of APIs is performed under Supply and Quality or Technical Agreements.

API production site is regularly inspected by the State Agency of Medicines of Latvia (SAM),  foreign authorities as well as it is audited by the API Customers from all over the world:

  • SAM GMP inspections are performed at least every 3 years, GMP Certificates are issued for human and veterinary APIs;
  • USA FDA pre-approval inspections recognize the API manufacturing unit of “«Grindeks»” as acceptable  to export three APIs to the USA market;
  • Australian TGA inspection issued GMP Certificate for one API;
  • Pharmaceutical Inspection of Russia recognized the API manufacturing unit of “«Grindeks»” as acceptable;
  • Third party audits were performed successfully by European API Committee on behalf of our Customers;
  • Customer Audits are performed frequently – 10 to 15 audits per year.