Santa Farma Pharmaceuticals, one of Türkiye’s established pharmaceutical manufacturers, has successfully completed another key regulatory audit reinforcing its global market presence. The company’s manufacturing facility located in GEBKİM Dilovası, Kocaeli, passed the GMP (Good Manufacturing Practices) inspection conducted by Peru’s health authority, DIGEMID (Dirección General de Medicamentos, Insumos y Drogas).
The comprehensive inspection, carried out between November 17–21, 2025, concluded with a “successful” evaluation. Following the completion of the official procedures, Santa Farma was granted a GMP certificate valid until November 2030.
Compliance with International Standards Confirmed
During the DIGEMID inspection, key areas such as manufacturing infrastructure, cleaning validation, deviation and documentation management, training systems, computerized systems validation, and risk management practices were thoroughly evaluated.
Santa Farma demonstrated strong performance across quality management systems and operational processes, reaffirming that its production capabilities align with global pharmaceutical manufacturing standards.
CEO Kiresepi: “Quality Is at the Core of Our Culture”
Santa Farma CEO Sami Kiresepi emphasized that quality is a fundamental pillar of the company’s corporate culture.
Kiresepi stated:
“At Santa Farma, we view quality not merely as a requirement but as a core element of our corporate culture, and we consistently reflect this approach across all our operations. Successfully completing the DIGEMID GMP inspection clearly demonstrates that our manufacturing infrastructure and quality systems fully comply with international standards. This outcome will further strengthen and sustain our regulatory approval and market access processes in the region.”
Strengthening Position in Global Markets
With more than 80 years of experience in the pharmaceutical industry, Santa Farma continues to enhance its manufacturing and quality infrastructure in line with international regulatory standards. The successful DIGEMID inspection represents an important milestone for the company, particularly in expanding its presence in Latin American markets.
