The injection, available in a 50 mEq/50 mL (1 mEq/mL) single-dose vial, is bioequivalent and therapeutically equivalent to Abbott Laboratories’ reference listed drug, the company said in an exchange filing.
Glenmark said it will begin distributing the product in November 2025.
According to IQVIA, sales data for the 12 months ending August 2025, the market for 8.4% Sodium Bicarbonate Injection, 50 mEq/50 mL (1 mEq/mL) achieved annual sales of approximately $63.8 million.
Sodium Bicarbonate Injection is used to treat metabolic acidosis, a condition where the body produces excess acid. This can happen in cases such as severe kidney disease, uncontrolled diabetes, shock or dehydration, heart failure during cardiac arrest, or high levels of lactic acid in the blood.
"We are pleased to announce the expansion of our injectable portfolio to include the upcoming launch of 8.4% Sodium Bicarbonate Injection USP, which further reinforces our dedication to bring quality and affordable alternatives to market to patients in need," Marc Kikuchi, President and Business Head, North America, Glenmark Pharmaceuticals Inc., USA, said.
Glenmark’s 8.4% Sodium Bicarbonate Injection USP is approved only for the indications listed in its approved label. The company clarified that the market data includes both the brand and all available therapeutic equivalents, but Glenmark’s product will be marketed only for its approved indications.
Shares of Glenmark were trading 1.21% lower at ₹1,874.95 apiece on the BSE at around 9.40 am.
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