WHO confirms prequalification status for dexamethasone (sodium phosphate) injection
The World Health Organization (WHO) has confirmed continued prequalification status for Farmak Group’s dexamethasone (as sodium phosphate) injection following a routine requalification in March 2025.
The outcome confirms that the product continues to meet WHO prequalification standards of quality, safety, and efficacy.
The product was first prequalified in 2020, at the height of the global pandemic, when intensive-care units worldwide faced unprecedented demand. The 2025 renewal reflects consistent performance across the value chain, including manufacturing, quality systems, regulatory compliance, and reliable supply planning.
WHO Prequalification is a stringent assessment process that supports access to quality-assured health products. Prequalified products are eligible for procurement by UN agencies and many global health partners, subject to program requirements and local regulations.
WHO prequalification is not a one-time milestone, it requires sustained evidence that a product and its supporting systems remain robust. The 2025 requalification confirms our day-to-day discipline across Regulatory, Quality, and Manufacturing. We appreciate the cross-functional work that keeps this medicine consistently aligned with international expectations.
Dmytro Firsovskyi Head of Regulatory Affairs, Farmak International
About the product: dexamethasone (as sodium phosphate) injection
Dexamethasone sodium phosphate is a parenteral corticosteroid used in hospital and critical-care settings for its anti-inflammatory and immunosuppressive effects. Dexamethasone sodium phosphate may be used in hospital and critical-care settings in accordance with local labeling and clinical guidelines.. Dexamethasone is included on the WHO Model List of Essential Medicines. Formulations of the phosphate salt are water-soluble, enabling intravenous or intramuscular administration and a rapid onset of action.
Note: Indications, dosing, and presentations may vary by country. Healthcare professionals should consult the locally approved prescribing information (SmPC/PI).
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