We are proud to share that our U.S. subsidiary, Milla Pharmaceuticals Inc., has received Abbreviated New Drug Application (ANDA) approval from the FDA for our 8.4% Sodium Bicarbonate Injection, USP (50 mEq/ 50 mL vials).
Sodium Bicarbonate for Injection is an essential alkalinizing agent used in hospitals and clinics. However, since 2013, this critical medicine has intermittently appeared on the FDA drug shortages list. By securing this FDA approval and preparing for launch, A.forall is taking a concrete step to bring stability back to the market. We are committed to combatting these persistent shortages and ensuring that healthcare providers have a reliable, high-quality supply of the medicines they need most.
This approval marks our 10th generic product in the United States and our second injectable designed to correct severe metabolic acidosis, following the launch of Tromethamine in January 2025.
