Santa Farma Successfully Passes ANVISA GMP Inspection

Santa Farma, a well-established pharmaceutical manufacturer in Turkey, has successfully completed another significant inspection as part of its growth strategy in international markets. The company's production facility in Kocaeli GEBKİM Dilovası passed a GMP (Good Manufacturing Practices) inspection conducted by Brazil's health authority ANVISA with a "Successful" rating.

Following a four-day inspection between 29 September and 2 October 2025, the facility earned GMP certification valid through January 2028. This inspection, conducted on behalf of Brazil—Latin America's largest and the world's ninth-largest pharmaceutical market—once again confirmed that Santa Farma's production and quality infrastructure complies with international standards.

Compliance with Global Standards Confirmed
Operating for over 80 years, Santa Farma continuously develops its quality systems in line with its vision of "becoming a reference company in the global health market that meets local needs with global quality standards."

During the ANVISA inspection process, particular emphasis was placed on:

-Modern production infrastructure

-Integrated structure of production and quality management systems

-Cleaning validation practices

-Computerised system validation

-Risk management procedures

among strong points.

"A Strong Indicator of Our Global Quality Approach"
Santa Farma CEO Sami Kiresepi commented on the inspection as follows:

"The successful completion of the GMP inspection conducted by one of the world's most competent health authorities like ANVISA is an important indicator of Santa Farma's global quality approach. This outcome achieved in Brazil, the largest pharmaceutical market in Latin America, reinforces confidence in the transparency of our production processes, our technical competence and our quality-focused working culture. Our aim is to continue providing products that patients can safely access in all markets where we operate, with our sustainable quality approach."

Strong Contribution to Latin America Strategy
Santa Farma, which manages all processes from development to production in-house, has strengthened its ability to advance licensing procedures in the Latin American market more swiftly and securely with this certification.

ANVISA approval is expected to increase the company's competitive strength in international markets while providing significant momentum to its growth strategy in the region, particularly in Brazil.