PSK Pharma Obtains Registration Certificates for Sitagliptin and Calcium Folinate
PSK Pharma, a Russian pharmaceutical company with a full-cycle GMP-compliant facility in the Dubna Special Economic Zone, has expanded its portfolio with two essential medicines form the List of Vital and Essential Medicines: calcium folinate (oncology) and sitagliptin (endocrinology).
Calcium Folinate will be manufactured by PSK as a solution for intravenous and intramuscular administration in two concentrations: 5 mg/ml and 10 mg/ml. It is used to reduce the toxicity of antitumor therapy in both adults and children undergoing cancer treatment.
Sitagliptin will be marketed under the trade name Sitagliptin PSK in tablet form with three dosages: 25 mg, 50 mg, and 100 mg. It is indicated for adults aged 18 and older as monotherapy or combination therapy to control blood sugar levels in type 2 diabetes mellitus.
According to the International Diabetes Federation, 643 million people worldwide will suffer from diabetes by 2030, increasing to 783 million by 2045. Type 2 diabetes accounts for 92.33% of all diabetes cases and is closely linked to obesity epidemics and lifestyle factors.
A large-scale Russian epidemiological study (NATION) revealed that type 2 diabetes is more prevalent in Russia than official statistics suggest. Among adults, 19.3% had had prediabetes, while 54% of cases had not been previously diagnosed.
"Diabetes and cancer are diseases of the 21st century. It is critical to ensure timely access to safe and high-quality products for patients diagnosed with these conditions, regardless of external factors influencing availability of necessary therapies. PSK Pharma's manufacturing capabilities allow flexible adaptation to growing demand for VED -listed medications, thereby minimizing the impact of these diseases on patients' lives," commented Evgenia Shapiro, General Director of PSK Pharma.